Patient-controlled sedation versus intravenous sedation for colonoscopy in elderly patients: a prospective randomized controlled trial

BACKGROUND: A prospective randomized trial was conducted to compare the safety, effectiveness, and patient acceptance of patient-controlled sedation and intravenous sedation for colonoscopy in a group of elderly patients undergoing outpatient colonoscopy. METHODS: One hundred patients over 65 years of age were recruited and randomized to patient-controlled sedation (n = 50) or intravenous sedation (n = 50) groups by means of computer-generated numbers. In the patient-controlled sedation group, a mixture of propofol and alfentanil was delivered by means of a patient-controlled pump; each bolus delivered 4.8 mg propofol and 12 microg alfentanil. No loading dose was used and the lockout time was set at zero. In the intravenous sedation group, fixed doses of diazemuls (0.1 mg/kg) and meperidine (0.5 mg/kg) were given with further increases in dosages administered at the discretion of the endoscopist. Outcome measures assessed included cardiopulmonary complications, recovery time, pain score, and satisfaction score. RESULTS: The mean (SD) age of patients in the patient-controlled sedation and intravenous sedation groups were, respectively, 72.4 years (5.3) and 73.5 years (6.1). The mean dose of propofol consumed in the patient-controlled sedation group was 0.79 (0.46) mg/kg. The mean doses of diazemuls and meperidine consumed in intravenous sedation group were, respectively, 5.8 (1.3) mg and 30.1 (6.8) mg. Hypotension occurred in 2 (4%) patients in the patient-controlled sedation group and 14 (28%) in the intravenous sedation group (p < 0.01). Oxygen desaturation was recorded for 4 patients (8%) in the intravenous sedation group. The median (interquartile range [IQR]) recovery time was significantly shorter in the patient-controlled sedation group compared with the intravenous sedation group (respectively, 0 minutes [IQR 0-5] vs. 5 minutes [IQR 5-10]; p < 0.01). There were no statistically significant differences between groups for pain and satisfaction scores. CONCLUSIONS: Patient-controlled sedation appears to be safer than intravenous sedation, with comparable effectiveness and acceptance, in elderly patients undergoing elective outpatient colonoscopy.     

Relaxation music decreases the dose of patient-controlled sedation during colonoscopy: a prospective randomized controlled trial.

BACKGROUND: A prospective randomized controlled trial was performed to test the hypotheses that music decreases the dose of sedative medication required for colonoscopy and that the combination of music and patient-controlled sedation improves patient acceptance of colonoscopy. METHODS: One hundred sixty-five patients scheduled to undergo elective colonoscopy were randomized to receive 1 of 3 different modes of sedation: Group 1, a combination of music and patient-controlled sedation with a mixture of propofol and alfentanil; Group 2, patient-controlled sedation alone; Group 3, music alone with diazemuls and meperidine administered intravenously if requested by the patient. Each bolus of patient-controlled sedation delivered 4.8 mg propofol and 12 microg alfentenil. Music was provided by means of a portable compact disc machine with headphones. Outcome measures assessed immediately after colonoscopy and 24 hours later included dose of patient-controlled sedation used, complications, recovery time, pain score, satisfaction score, and willingness to repeat the procedure with the same mode of sedation. RESULTS: The mean (SD) dose of propofol used in Group 1 was significantly less than Group 2 (0.84 mg/kg [0.69 mg/kg] vs. 1.15 mg/kg [0.83 mg/kg]; p = 0.02, t test). The mean (SD) satisfaction score was higher in Group 1 (7.8 [2.1]) compared with Group 2 (6.8 [2.3]) and Group 3 (7.4 [2.3]) (p = 0.05, 1-way analysis of variance). The majority of patients in Group 1 were willing to repeat the same mode of sedation when queried immediately after colonoscopy (87%) and 24 hours later (75%), which was significantly different from the corresponding results in the other 2 groups; p = 0.04 and p < 0.01 respectively, chi-square test. CONCLUSIONS: Music can decrease the dose of sedative medication required for colonoscopy. The combination of music and patient-controlled sedation was the best-accepted mode of sedation among 3 groups.     

Conscious analgesia/sedation with remifentanil and propofol versus total intravenous anesthesia with fentanyl,midazolam, and propofol for outpatient colonoscopy

BACKGROUND: This study tested the hypothesis that, for colonoscopy, analgesia/sedation with remifentanil and propofol might be more effective compared with anesthesia by intravenous administration of midazolam, fentanyl, and propofol. METHODS: In a prospective, randomized trial, 100 adult patients received either conscious analgesia/sedation (Sedation group) or total intravenous anesthesia (TIVA group). Analgesia/sedation was achieved by infusion of remifentanil (0.20 to 0.25 microg/kg/min) and propofol in titrated doses. TIVA was induced by intravenous administration of fentanyl (2 microg/kg), midazolam (0.05 mg/kg) and propofol (dosage titrated). Cardiorespiratory parameters and bispectral index were monitored and recorded. The quality of the analgesia was assessed with a Numerical Pain Rating Scale (NRS); recovery level and return of psychomotor efficiency were evaluated with, respectively, the Aldrete scale and a Modified Post Anesthesia Discharge Scoring (MPADS) system. RESULTS: Both groups of 50 patients were comparable with respect to demographic data, initial parameters, and duration of colonoscopy. All patients in the TIVA group found the colonoscopy painless (NRS score 0). In the Sedation group, the average pain intensity score was 0.4 (0.8). There was a marked difference between the Sedation and TIVA groups with respect to the time from the end of the procedure until the maximum MPADS score was reached: respectively, -6.9 (4.0) versus 25.7 (8.4) minutes (p < 0.001). In the TIVA group, changes in mean arterial pressure and heart rate and signs of respiratory depression were significant (p < 0.05). CONCLUSIONS: Combined administration of remifentanil and propofol for colonoscopy provides sufficient analgesia, satisfactory hemodynamic stability, minor respiratory depression, and rapid recovery, and allows patients to be discharged approximately 15 minutes after the procedure.     

Nurse-administered propofol versus midazolam and meperidine for upper endoscopy in cirrhotic patients

OBJECTIVES: Upper GI endoscopy is often performed in patients with chronic liver disease to screen for esophageal and gastric varices. Propofol is currently under evaluation as an alternative to the combination of midazolam and meperidine for sedation during endoscopic procedures. The purpose of this study was to compare nurse-administered propofol to midazolam and meperidine for sedation in patients with chronic liver disease undergoing diagnostic upper GI endoscopy. METHODS: Twenty outpatients who had known chronic liver disease (Child-Pugh class A or B) and were undergoing variceal screening were randomized to receive propofol or midazolam plus meperidine for sedation. Administration of sedation was performed by a registered nurse and supervised by the endoscopist. Outcome measures studied were induction and recovery times, efficacy and safety of sedation, patient satisfaction, and return to baseline function. RESULTS: The mean dose of propofol and meperidine/midazolam administered was 203 mg (SD 43.7, range 150-280) and 71.3 mg (SD 17.7, range 50-100)/5.3 mg (SD 0.9, range 3.0-6.0), respectively. The mean time to achieve adequate sedation was 3.6 min (SD 1.2) for the propofol group in comparison to 7.3 min (SD 2.8) for the meperidine/midazolam group (p<0.05). Procedure times between the groups were similar: propofol, 3.9 min (SD 1.9); midazolam/meperidine, 2.7 min (SD 0.8) (p=0.11). The level of sedation achieved by the propofol group was greater (p=0.0001). Time to full recovery was faster in the propofol group: 34.9 min (SD 10.3) versus 51.6 min (SD 18.4) (p<0.05). The mean time to reach a maximal level of alertness on the Observer's Assessment of Alertness and Sedation Scale for the propofol group was 15 min (SD 3.6) versus 29 min (SD 10.5) (p=0.001). Although both groups recorded a high level of satisfaction, patients receiving propofol expressed greater overall mean satisfaction with the quality of their sedation at the time of discharge (p<0.05), and reported a return to baseline function sooner in the majority of cases. Propofol achieved comparable levels of efficacy and safety to meperidine/midazolam in our study group. Both were well tolerated with minimal complications. CONCLUSIONS: Propofol sedation administered by registered nurses in the setting of adequate patient monitoring is efficacious and well tolerated in patients with liver disease who are undergoing variceal screening by upper endoscopy. Patients were more satisfied with the quality of sedation, and return to baseline function was usually sooner compared to results achieved with midazolam/meperidine. Propofol offers advantages over meperidine/midazolam in cirrhotic patients.     

Technical performance of colonoscopy in patients sedated with nurse-administered propofol

OBJECTIVES: Nurse-administered propofol has gained attention as a safe and effective means of sedation for patients undergoing endoscopic procedures. However, little is known about the effect of propofol on the technical performance of colonoscopy. METHODS: Three separate studies were conducted. In the first study, we reviewed procedure notes from consecutive colonoscopies performed by a single experienced endoscopist at our hospital endoscopy unit on patients sedated with either nurse-administered propofol (n = 162) or midazolam/narcotic (n = 164). In the second study, 100 eligible colonoscopy outpatients were randomized to receive either nurse-administered propofol (n = 50) or midazolam/fentanyl (n = 50). In both studies, the measured parameters included visualization of the cecum, time required to reach the cecum, repositioning of the patient, and the application of abdominal counterpressure. In a third study, we reviewed the rate of cecal intubation and colonic perforation in the first 2357 patients in our unit receiving nurse-administered propofol. RESULTS: In the retrospective comparative study, there was no difference in the cecal intubation rate in those receiving propofol (99.4%) compared to those receiving midazolam/narcotic (97%; p= 0.1), and three of five failed cecal intubations in the latter group resulted from obstructing masses. Patients sedated with propofol were repositioned less frequently compared to those receiving midazolam/narcotic (3.7%vs 26.2%) (p < 0.0001). Abdominal pressure was employed in 9.9% of patients sedated with propofol compared to 19.5% (p= 0.01) of those given midazolam/narcotic. The mean time to reach the cecum was lower in the propofol group than in the midazolam/narcotic group (4.6 min vs 6.0 min, p= 0.002). In the prospective randomized study, the endoscopist intubated the cecum in all 100 patients. Patients in the propofol group were repositioned less frequently than those in the midazolam/fentanyl group (2%vs 24%, respectively, p= 0.001). The number of cases requiring abdominal counterpressure was not significantly different between the propofol and midazolam/fentanyl groups (12%vs 24%, respectively, p= 0.1). The mean time to reach the cecum in the propofol group (3.2 min) was similar to that in the midazolam/fentanyl group (3.8 min, p= 0.08). Among the first 2357 patients in our unit undergoing colonoscopy with nurse-administered propofol, the rate of complete colonoscopy was 99.2% and there were no perforations. CONCLUSION: Nurse-administered propofol sedation is safe and simplifies the technical performance of colonoscopy compared to midazolam/narcotic sedation.     

Sedation and Analgesia for Gastrointestinal Endoscopy

We compared analgesia and sedation provided by one of four different opioids in combination with midazolam during gastrointestinal endoscopy. Patients were given 1–3 mg midazolam and meperidine 50–100 mg, fentanyl 50–100 μg, sufentanil 5–10 μg, or alfentanil 150–300 μg, plus additional opioid and/or midazolam if needed. No untoward effects ( i.e. , O₂ saturation <85%, nausea, vomiting, severe bradycardia) occurred. Sedation and analgesia were comparable in the upper gastrointestinal groups. The number of patients with amnesia for the exahmination was highest in the meperidine group. Recovery time generally was shorter with alfentanil and sufentanil. Recovery time of the lower gastrointestinal patients was significantly longer in the meperidine group than in the other groups; analgesia scores for sufentanil were significantly lower than for meperiodin. sedation scores of these patients were highest in the meperiding group. The number of patients given meperidine who wee amnesic was significantly greater than for the other opioids. Meperidine was better than the other opioids with regard to patients comfort and amnesia during colonoscopy.     

Propofol versus midazolam/meperidine for outpatient colonoscopy: administration by nurses supervised by endoscopists

BACKGROUND: Propofol is under evaluation as a sedative for endoscopic procedures. METHODS: Eighty outpatients (ASA Class I or II) undergoing colonoscopy were randomized to receive either propofol or midazolam plus meperidine, administered by a nurse and supervised by an endoscopist. Endpoints were patient satisfaction, procedure and recovery times, neuropsychological function, and complications. RESULTS: The mean dose of propofol administered was 218 mg; mean doses of midazolam and meperidine were, respectively, 4.7 mg and 89.7 mg. Mean time to sedation was faster in the propofol patients (2.1 min vs. 7.0 min; p < 0.0001), and depth of sedation was greater (p < 0.0001). On average, after the procedure, the propofol patients could stand at the bedside sooner (14.2 vs. 30.2 min), reached full recovery faster (14.4 vs. 33.0 min), and were discharged sooner (40.5 vs. 71.1 min) (all p < 0.0001). Patients who received propofol also expressed greater overall mean satisfaction on a 10-point visual analog scale (9.3 vs. 8.6; p < 0.05). At discharge, the propofol group had better scores on tests reflective of learning, memory, working memory span, and mental speed. Four patients in the midazolam/meperidine group developed minor complications (1 hypotension and bradycardia, 2 hypotension alone, and 1 tachycardia) and 1 patient in the propofol group had oxygen desaturation develop during an episode of epistaxis. CONCLUSION: For outpatient colonoscopy, propofol administered by nurses and supervised by endoscopists has several advantages over midazolam plus meperidine and deserves additional investigation.     

Sedation with propofol for routine ERCP in high-risk octogenarians: a randomized, controlled study

OBJECTIVES: Adequate patient sedation is mandatory for diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP). In this respect it is known that the short-acting anesthetic propofol offers certain potential advantages for sedation during ERCP, but there are no controlled studies concerning the feasibility and safety of propofol sedation in elderly, high-risk patients. METHODS: One hundred and fifty consecutive patients aged >or=80 yr with high comorbidity (ASA score >or=III: 91 %), randomly received midazolam plus meperidine (n = 75) or propofol alone (n = 75) for sedation during ERCP. Vital signs were continuously monitored and procedure-related parameters, recovery time, and quality as well as patients' cooperation and tolerance of the procedure were assessed. RESULTS: Clinically relevant changes in vital signs were observed at comparable frequencies with a temporary oxygen desaturation (<90%) occurring in eight patients in the propofol-group and seven patients receiving midazolam/meperidine (n.s.). Hypotension was documented in two patients in the propofol group and one patient receiving midazolam/meperidine. Propofol provided a significantly better patient cooperation than midazolam/meperidine (p < 0.01), but the procedure tolerability was rated nearly the same by both groups. Mean recovery time was significantly shorter in the propofol group (22 +/- 7 min vs 31 +/- 8 min for midazolam/meperidine (p < 0.01)) while the recovery score was significantly higher under propofol (8.3 +/- 1.2 vs 6.1 +/- 1.1(p < 0.01)). During recovery a significant lower number of desaturation events (<90%) were observed in the propofol group (12%) than in the midazolam/meperidine group (26%, p < 0.01). CONCLUSION: Under careful monitoring the use of propofol for sedation during ERCP is superior to midazolam/meperidine even in high-risk octogenarians.     

Effect of magnetic endoscope imaging on patient tolerance and sedation requirements during colonoscopy: a randomized controlled trial

BACKGROUND: Pain during colonoscopy is primarily related to mesenteric stretching from looping of the colonoscope insertion tube. Prompt recognition and removal of loops reduces patient discomfort and may lessen sedation requirements. Magnetic endoscope imaging allows real-time visualization of the colonoscope during insertion. The effect of magnetic endoscope imaging on patient pain and sedation requirements was assessed in a prospective randomized controlled trial. METHODS: A total of 122 consecutive patients undergoing routine colonoscopy by a single experienced endoscopist were randomized to have the procedure performed either with the endoscopist viewing the imager display (n = 62), or without the imager view (n = 60). Procedures began with administration of hyoscine-N-butylbromide alone, and sedative medications (midazolam and meperidine) were self-administered by the patient with a patient-controlled analgesia pump. Cardiorespiratory parameters were recorded and patient pain was assessed with a 100-mm visual analogue scale. RESULTS: The number of attempts at straightening the colonoscope was fewer (median 8 [0-66] vs. 15 [0-87], p = 0.0076) and the duration of looping less (median 4.5 min [0-27.3 min] vs. 6.4 min [0-29.4 min]), when the endoscopist was able to see the imager view. The total number of patient demands (by patient-controlled analgesia) for medication (median 1 vs. 2.5) and total doses of midazolam (median 0.44 mg vs. 0.88 mg) and meperidine (median 16.75 mg vs. 32.5 mg) administered did not significantly differ between patients examined with or without the imager. Patient pain scores were also similar. CONCLUSIONS: Magnetic endoscope imaging allows accurate assessment and straightening of loops during colonoscopy, but without a significant reduction in patient requirements for sedative medication or improvement in patient tolerance. However, the dosages of sedation drugs used were small.     

Routine versus "on demand" sedation and analgesia for colonoscopy: a prospective randomized controlled trial

BACKGROUND: The safety and tolerance of routine sedation and analgesia versus "on demand" sedation were compared in patients undergoing colonoscopy. METHODS: Two hundred forty-nine outpatients were randomly assigned to one of two groups. Group A (n = 125) received midazolam, 0.07 mg/kg intravenously plus meperidine, 0.77 mg/kg intravenously immediately preceding the colonoscope insertion. Group B (n = 124) received the same medication upon request during the procedure. Tolerance was assessed 24 hours later by phone interview performed by a nurse blinded to the medication regimen administered. RESULTS: Eighty-three patients (66%) in Group B required sedation during colonoscopy. Among men in Group B more than 60 years of age, only 23% required sedation. The proportion of patients reporting moderate or severe pain (34% vs. 12.1%, p < 0.001) and of those stating they would not be willing to undergo colonoscopy again in the future (22% vs. 9.7%, p < 0.005) was significantly higher in the "on demand" sedation group. By multivariate analysis the randomization group was the single variable independently associated with both such outcomes. The frequency of side effects was similar in the two groups. CONCLUSIONS: Administration of sedative and analgesic drugs routinely before colonoscopy is superior to "on demand" sedation in terms of tolerance and is not associated with an increase in side effects.     

Patient-controlled sedation with propofol for colonoscopy.

BACKGROUND: Patient-controlled sedation (PCS) allows the patient to titrate the dosage of sedative drugs according to need. METHODS: To compare the efficacy of PCS by using propofol with anesthetist-administered midazolam during colonoscopy, 88 patients were randomized to receive either intravenous midazolam 0.05 mg/kg bolus (1 mg increments as required) or propofol PCS (0.3 mg/kg bolus, zero lockout). Heart and respiratory rates, blood pressure, and oxygen saturation were monitored. Patient cooperation, endoscopist satisfaction, and level of sedation were scored. Patient satisfaction was assessed by questionnaire. To correct for multiple testing of data, statistical significance was asserted only for individually stated p values with p < 0.01. RESULTS: Oxygen saturation and hemodynamics were stable in both groups. Better patient cooperation (good vs. minimal; p = 0.008) and higher endoscopist satisfaction (very good vs. good; p = 0.001) were achieved with PCS. Although more sedated intraoperatively (sedation score 4 vs. 2; p = 0.03 for a single test of hypothesis; correction for multiple testing of data removes this significance), patients in the propofol PCS group were more alert by 30 minutes and discharged earlier (mean and SD times were 43.3 [12.1] min compared with 61.0 [29.7] min; p = 0.001.) More patients in the PCS group (86 vs. 6l%; p < 0.001) were satisfied with their overall level of comfort. CONCLUSION: PCS with propofol is effective and results in high patient satisfaction and faster discharge.     

Midazolam and pethidine versus propofol and fentanyl patient controlled sedation/analgesia for upper gastrointestinal tract ultrasound endoscopy: A prospective randomized controlled trial

BACKGROUND AND OBJECTIVES: The aim of this prospective, randomized study was to compare the standard regimen of midazolam and pethidine administered by the gastroenterologist versus patient controlled sedation with a propofol-fentanyl mixture during upper gastrointestinal tract endoscopic ultrasonography. Our primary end-points were patient satisfaction and patient cooperation assessed by endoscopist. METHODS: Fifty-four consecutive patients, undergoing endoscopic ultrasonography, received sedation with midazolam and pethidine (Group M: n=27) or propofol and fentanyl (Group P: n=27). Group M: pethidine 0.7mg/kg midazolam 0.04mg/kg before examination; boluses of same drugs if the sedation was insufficient plus a sham patient controlled sedation analgesia; Group P: propofol 17mg plus fentanyl 15microg before examination and a patient controlled sedation analgesia pump containing 170mg propofol plus 150microg fentanyl injecting 0.5ml every time the patient pressed the button (no "lock out"). Boluses of 1ml of the same mixture if the sedation was insufficient. RESULTS: Group M: mean dosage of pethidine and midazolam 88.6 and 5mg, respectively. Group P: mean dosage of propofol and fentanyl 119.7mg and 106microg, respectively. Both groups were similar for duration and difficulty of the procedure, the grade of sedation (Observer's Assessment of Alertness/Sedation Score) and judgement by endoscopist and patient about cooperation and satisfaction. The only difference between groups was about the extra boluses administered during the procedure. CONCLUSION: This study demonstrated that a patient controlled sedation analgesia with propofol and fentanyl is an effective and safe technique for upper gastrointestinal tract endoscopic ultrasonography procedures and results in a high level of satisfaction both for patients and operator.     

Propofol for endoscopic sedation: A protocol for safe and effective administration by the gastroenterologist

BACKGROUND: There is increasing interest in the use of propofol, an ultrashort-acting hypnotic agent, for sedation during endoscopic examinations. A protocol was developed for administration of propofol, combined with small doses of midazolam and meperidine, for endoscopic sedation under the direction of a gastroenterologist. Initial experience with using this protocol is described. METHODS: A total of 819 consecutive endoscopic examinations under sedation with propofol, midazolam, and meperidine (or fentanyl), in adherence with the sedation protocol, were reviewed retrospectively. RESULTS: There were 638 colonoscopies and 181 EGDs; 89% of patients were classified as American Society of Anesthesiologists (ASA) class I or II. Mean dosages of medications were: propofol 63 (33.5) mg, meperidine 48 (7.2) mg, and midazolam 1 (0.12) mg. The dose of propofol was inversely correlated with age and ASA class, and positively correlated with patient weight and duration of examination. Hypotension (>20 mm Hg decline in either systolic or diastolic blood pressure) developed in 218 (27%) patients, and hypoxemia (oxygen saturation <90%) developed in 75 (9%). All episodes of hypotension and hypoxemia were transient, and no patient required administration of a pharmacologic antagonist or assisted ventilation. The average time for recovery after colonoscopy and after EGD was, respectively, 25 minutes and 28 minutes. All EGDs and 98% of colonoscopies were completed successfully. CONCLUSIONS: On the basis of this initial experience, it is believed that propofol, potentiated by small doses of midazolam and meperidine, can be safely and effectively administered under the direction of a gastroenterologist. Additional research will be necessary to determine whether propofol is superior to the current methods of sedation.     

Intermittent manually controlled versus continuous infusion of propofol for deep sedation during interventional endoscopy: A prospective randomized trial

Abstract Introduction. Beside the traditional, intermittent bolus application of propofol, continuous propofol infusion via infusion pump is an alternative procedure for deep sedation during long-lasting interventional endoscopy. However, up to now, there are no randomized comparisons for gastrointestinal endoscopy. Methods. One hundred patients (ERCP: n = 60, EUS: n = 40) were randomly assigned to receive intermittent bolus application ("bolus group") or continuous infusion ("perfusor group") of propofol sedation after induction with 3 mg midazolam for deep sedation. Patients in the bolus group received an initial propofol dose according to body weight (bw <70 kg: 40 mg; bw ≥70 kg 60 mg). In the perfusor group, bw-adapted, continuous propofol infusion (6 mg/kg) via the Injectomat 2000 MC (Fresenius-Kabi) was administered after an initial bolus of 1 mg/kg. Vital signs, dose of propofol, patient cooperation (VAS 1-10), sedation depth, and the recovery time as well as the quality of recovery were evaluated. Results. Total propofol dose in the bolus group 305 ± 155 mg (100-570 mg) and in the perfusor group 343 ± 123 mg (126-590 mg, p = 0.5) were comparable. Oxygen saturation below 90% was seen in four patients of each group, with no need for assisted ventilation. Arterial blood pressure <90 mmHg was documented in two patients in the bolus group and seven patients in the perfusor group (p = 0.16). Patients' cooperation was rated as good in both groups (bolus group, 9.1 ± 0.9; perfusor group, 8.9 ± 1; p = 0.17). Recovery time was significantly shorter in the bolus group compared with the perfusor group (19 ± 5 versus 23 ± 6 min, p < 0.001) whereas the quality of recovery was nearly identical in both groups. Conclusion. Both sedation regimens allow nearly identical good controllability of propofol sedation. However, recovery time was significantly slower and hypotension was tended to occur more often in the perfusor group.     

Remifentanil/midazolam versus tramadol/midazolam use for colonoscopy

One of the most commonly performed outpatient procedure is colonoscopy. The pain and anxiety is frequently associated with colonoscopy. The aim of this study was to compare the effectiveness of remifentanil/midazolam, and tramadol/midazolam for iv sedation and analgesia during colonoscopy. Twentysix patients (age range 18-65 years) scheduled for ambulatory colonoscopy were included to study. All patients received midazolam 1 mg intravenous. After two minutes in Group R (remifentanil/midazolam, n=18) remifentanil bolus (10 microg) and infusion 0.03 microg kg(-1) min(-1) were administered until adequate sedation level was achieved. In Group T (tramadol/midazolam, n=18) iv tramadol 50 mg was given concurrently. During procedure 2 L/min oxygen was supplemented via face mask to all patients. Haemodynamic variables, respiratory depression, level of sedation, postoperative recovery, patient and gastroenterologist satisfaction were surveyed. Patients were asked to verbally rate their level of pain, on an 10-point numerical rating scale (1=no pain, 10=severe pain). Chi-square, student t test, and mann whitney U test were used for statistical analysis. Colonoscopy was carried out successfully in all patients. There were no episodes of desaturation or airway compromise. Haemodynamic parameters were similar in both groups. Sistolic arterial and diastolic arterial pressures were increased at 10 and 15 minutes in all patients (P<0.05). There were no significant changes in heart rate in both groups. The level of sedation in group R was higher than group T during colonoscopy. The patients in group T had higher pain scores. Gastroenterologist satisfaction and patient satisfaction were similar in both groups. Our results suggests that, sedoanalgesia with midazolam/remifentanil may be an alternative to sedoanalgesia with midazolam/tramadol for colonoscopy.     

Propofol versus midazolam and meperidine for conscious sedation in GI endoscopy

OBJECTIVE: Propofol (2,6-diisopropyl phenol) is a relatively new intravenous sedative hypnotic with an ideal pharmacokinetic profile for conscious sedation. In this study, we compared the safety and efficacy of propofol versus the conventional regimen of midazolam and meperidine for conscious sedation in GI endoscopy. METHODS: In this prospective study, 274 patients that included many elderly patients with multiple comorbid conditions underwent GI endoscopic procedures at our hospital. A total of 150 patients received propofol (20-120 mg) and fentanyl (0.25-1.5 mg). The control group of 124 patients was given midazolam (2-6 mg) and meperidine (25-75 mg). The dose of medication was titrated according to patient need and the duration of the procedure. A "comfort score" on a scale of 1-4 assessed the efficacy of the drugs based on pain or discomfort to the patient and ease of endoscopy. A "sedation score" was used to assess the degree of sedation on a scale of 1-5. The Aldrete score was used to measure recovery from anesthesia at 5 and 10 min after the procedure. RESULTS: After controlling for age, American Society of Anesthesiologists' Physical Status Classification (ASA grade), and type and duration of procedure, logistic regression analysis determined that propofol resulted in 2.04 times better patient comfort (p = 0.033, 95% CI = 1.058-3.923). Propofol was 1.84 times more likely to produce deeper sedation than the regimen of midazolam and meperidine (p = 0.027, 95% CI = 1.071-3.083). The recovery from sedation was faster in patients receiving propofol, although this did not reach statistical significance. The safety parameters between the two groups were comparable. CONCLUSION: Propofol was associated with a statistically significant improvement in comfort and sedation score when compared to midazolam and meperidine.     

Synergistic sedation with midazolam and propofol versus midazolam and pethidine in colonoscopies: a prospective,randomized study

OBJECTIVE: The aim of our study was to compare the safety and efficacy of the synergistic sedation with a low dose of midazolam combined with propofol versus the standard regimen of midazolam and pethidine for conscious sedation in colonoscopy in a group of patients that included a sufficient number of elderly patients with several comorbidities. METHODS: A total of 120 consecutive patients undergoing colonoscopy in a prospective study were randomly assigned to one of two medication regimens (55 patients were over 65 yr). Patients in group A (n = 64) received i.v. 2 mg (<70 kg b.w.) or 3 mg (>70 kg b.w.) of midazolam and a median dose of 80 mg of propofol (range 40-150). Patients in group B (n = 56) received i.v. a median dose of 5 mg of midazolam (range 3-7) and 75 mg of pethidine (range 50-125). The patient's comfort level was assessed by a 4-point scale 24 h after the procedure. The time to recover from sedation was assessed at 5, 10, and 30 min after the procedure by using the Aldrete score. RESULTS: Multivariate stepwise logistic regression analysis revealed that among sex, age, duration of the test, American Society of Anesthesiologists' Physical Status Classification grade, and the sort of sedation, the synergistic sedation with midazolam and propofol was the only factor associated with a higher level of patient comfort (chi2 = 5.5, p < 0.05). Additional multivariate stepwise logistic regression analysis revealed that among sex, age, duration of the test, American Society of Anesthesiologists' Physical Status Classification grade, and the sort of sedation, the synergistic sedation with midazolam and propofol was the only factor associated with a quicker patient recovery time (chi2 = 24.5, p < 0.01; chi2 = 51.7, p < 0.01; chi2 = 148.4, p < 0.01 for Aldrete in 10 min, 20 min, and 30 min, respectively). The endoscopist's evaluation of patient sedation and cardiorespiratory parameters were similar in both groups and in all age groups. CONCLUSIONS: Our data suggest that the synergistic sedation with a low dose of midazolam combined with propofol was superior to a standard combination of midazolam and the opioid pethidine for colonoscopies as far as the patient comfort and recovery times are concerned.     

Moderate level sedation during endoscopy: a prospective study using low-dose propofol, meperidine/fentanyl, and midazolam

BACKGROUND: Propofol provides several benefits over benzodiazepine and narcotic agents as a sedative medication for endoscopic procedures, including faster recovery and improved patient satisfaction. However, its use generally has been limited to anesthesiologists because of the risks associated with deep sedation. METHODS: One hundred patients undergoing colonoscopy or EGD were sedated with low-dose propofol, midazolam, and fentanyl (or meperidine). Depth of sedation was assessed at 2-minute intervals by an independent observer by using the American Society of Anesthesiologists criteria. Recovery time was determined by using paired neuropsychometric tests. A post-procedure satisfaction survey and 24-hour follow-up questionnaires were administered. RESULTS: For colonoscopy and EGD, respectively, the mean propofol dose was 98 mg and 79 mg, the mean midazolam dose was 0.9 mg and 0.8 mg, the mean fentanyl dose was 69 mcg and 63 mcg, and the mean meperidine dose was 42 mg (for both procedures). There were 628 assessments of the level of sedation performed during 74 colonoscopies and 101 assessments during 26 EGDs. The level of sedation was minimal in 77%, moderate in 21%, and deep in 2% of assessments. Nine of the 13 episodes of deep sedation were recorded during colonoscopy and 4 during EGD. In no instance was more than a single assessment of deep sedation recorded during one procedure. Ninety-eight percent of patients were satisfied with the sedation, and 71% returned to their usual activities within 2 hours of discharge. There was no serious adverse event. CONCLUSIONS: Endoscopic sedation with low-dose propofol, a narcotic agent, and midazolam produces a moderate level of sedation. The quality of sedation and measures of recovery are comparable with the results reported with standard-dose propofol.     

Safety and Efficacy of Deep Sedation with Propofol Alone or Combined with Midazolam Administrated by Nonanesthesiologist for Gastric Endoscopic Submucosal Dissection

Background/Aims

Endoscopic submucosal dissection (ESD) is accepted as a treatment for gastric neoplasms and usually requires deep sedation. The aim of this study was to evaluate the safety and efficacy profiles of deep sedation induced by continuous propofol infusion with or without midazolam during ESD.

Methods

A total of 135 patients scheduled for ESDs between December 2008 and June 2010 were included in this prospective study and were randomly assigned to one of two groups: the propofol group or the combination group (propofol plus midazolam).

Results

The propofol group reported only one case of severe hypoxemia with no need of mask ventilation or intubation. Additionally, 18 cases of mild hypotension were observed in the propofol group, and 11 cases were observed in the combination group. The combination group had a lower mean total propofol dose (378 mg vs 466 mg, p<0.012), a longer mean recovery time (10.5 minutes vs 7.9 minutes, p=0.027), and a lower frequency of overall adverse events (32.8% vs 17.6%, p=0.042).

Conclusions

Deep sedation induced by continuous propofol infusion was shown to be safe during ESD. The combination of continuous propofol infusion and intermittent midazolam injection can decrease the total dose and infusion rate of propofol and the overall occurrence of adverse events.     

Propofol versus midazolam/fentanyl for outpatient colonoscopy: administration by nurses supervised by endoscopists.

BACKGROUND & AIMS: Propofol is under evaluation as a sedative for endoscopic procedures. We compared nurse-administered propofol to midazolam plus fentanyl for outpatient colonoscopy. METHODS: One hundred outpatients undergoing colonoscopy were randomized to receive propofol or midazolam plus fentanyl, administered by a registered nurse and supervised only by an endoscopist. Endpoints were patient satisfaction, procedure and recovery times, neuropsychologic function, and complications. RESULTS: The mean dose of propofol administered was 277 mg; mean doses of midazolam and fentanyl were 7.2 mg and 117 microg, respectively. Mean time to sedation was faster with propofol (2.1 vs. 6.1 min; P<0.0001), and depth of sedation was greater (P<0.0001). Patients receiving propofol reached full recovery sooner (16.5 vs. 27.5 min; P=0.0001) and were discharged sooner (36.5 vs. 46.1 min; P=0.01). After recovery, the propofol group scored better on tests reflective of learning, memory, working memory span, and mental speed. Six minor complications occurred in the propofol group: 4 episodes of hypotension, 1 episode of bradycardia, and 1 rash. Five complications occurred with the use of midazolam and fentanyl: one episode of oxygen desaturation requiring mask ventilation and 4 episodes of hypotension. Patients in the propofol vs. midazolam and fentanyl groups reported similar degrees of overall satisfaction using a 10-cm visual analog scale (9.3 vs. 9.4, P>0.5). CONCLUSIONS: Nurse-administered propofol resulted in several advantages for outpatient colonoscopy compared with midazolam plus fentanyl, but did not improve patient satisfaction.