Double-blind controlled trial of flumazenil in patients who underwent upper gastrointestinal endoscopy

The antisedative effect of flumazenil, a benzodiazepine antagonist, was studied in a double-blind placebo controlled trial in 61 patients who underwent upper gastrointestinal endoscopy and sedation with benzodiazepines. The efficacy of flumazenil in reversing the effect of both benzodiazepines, diazepam and midazolam, was significantly higher than placebo (p less than 0.0001). The effect of flumazenil was prompt and was clearly noticed at the first assessment, 5 min after its administration. In none of the patients was a relapse of the sedative effect of the benzodiazepines noticed. The administration of flumazenil was free of major side effects. Flumazenil administration permits an earlier discharge of patients following endoscopy. Its availability in the endoscopy suite may improve the outcome of serious but rare side effects related to benzodiazepines.     

Unsedated ultrathin upper endoscopy is better than conventional endoscopy in routine outpatient gastroenterology practice： A randomized trial

AIM: to compare the feasibility and patients' tolerance of esophagogastroduodenoscopy (EGD) using a thin endoscope with those of conventional oral EGD and to determine the optimal route of introduction of small-caliber endoscopes. METHODS: One hundred and sixty outpatients referred for diagnostic EGD were randomly allocated to 3 groups: conventional (C)-EGD (9.8 mm in diameter), transnasal (TN)-EGD and transoral (TO)-EGD (5.9 mm in diameter). Pre-EGD anxiety was measured using a 100-mm visual analogue scale (VAS). After EGD, patients and endoscopists completed a questionnaire on the pain, nausea, choking, overall discomfort, and quality of the examination either using VAS or answering some questions. The duration of EGD was timed. Blood oxygen saturation (SaO2) and heart rate (HR) were monitored during EGD. RESULTS: Twenty-one patients refused to participate in the study. The 3 groups were well-matched for age, gender, experience with EGD, and anxiety. EGD was completed in 91.1% (41/45), 97.5% (40/41), and 96.2% (51/53) of cases in TN-EGD, TO-EGD, and C-EGD groups, respectively. TN-EGD lasted longer (3.11 ± 1.60 min) than TO-EGD (2.25 ± 1.45 min) and C-EGD (2.49 ± 1.64 min) (P < 0.05). The overall tolerance was higher (P < 0.05) and the overall discomfort was lower (P < 0.05) in TN-EGD group than in C-EGD group. EGD was tolerated "better than expected" in 73.2% of patients in TN-EGD group and 55% and 39.2% of patients in TO-EGD and C-EGD groups, respectively (P < 0.05). Endoscopy was tolerated "worst than expected" in 4.9% of patients in TN-EGD group and 17.5% and 23.5% of patients in TO-EGD and C-EGD groups, respectively (P < 0.05). TN-EGDcaused mild epistaxis in one case. The ability to insufflate air, wash the lens, and suction of the thin endoscope were lower than those of conventional instrument (P < 0.001). All biopsies performed were adequate for histological assessment. CONCLUSION: Diagnostic TN-EGD is better tolerated than C-EGD. Narrow-diameter endoscope has a level of diagnostic accuracy comparable to that of conventional gastroscope, even though some technical characteristics of these instruments should be improved. Transnasal EGD with narrow-diameter endoscope should be proposed to all patients undergoing diagnostic EGD.     

Pharmacoeconomic evaluation of flumazenil for routine outpatient EGD

BACKGROUND: Flumazenil is a benzodiazepine antagonist indicated for reversal of the sedative effects of benzodiazepines. Previous studies suggest that flumazenil may shorten recovery time after endoscopy, but there are few data on actual recovery room times and charges. METHODS: Fifty patients undergoing routine upper endoscopy were sedated with midazolam alone in the usual titrated manner. Patients were randomized in a double-blind fashion to receive either flumazenil or saline immediately after procedure. Assessments of responsiveness, speech, facial expression, and ptosis (Observer's Assessment of Alertness/Sedation [OAA/S] scale) were made before procedure, immediately after procedure and every 15 minutes thereafter. The patient was discharged from the recovery room when vital signs and OAA/S scale reached preprocedure levels. Recovery room times and charges were recorded. RESULTS: The flumazenil group demonstrated shorter recovery room times and recovery room charges than the placebo group (p < 0.001). The difference in recovery room charges was not statistically different when flumazenil charges were included (p = 0.09). CONCLUSIONS: The routine use of flumazenil after midazolam sedation for upper endoscopy significantly shortened recovery time and charges but did not statistically reduce overall charges.     

Premedication with orally administered midazolam in adults undergoing diagnostic upper endoscopy: a double-blind placebo-controlled randomized trial

BACKGROUND: A double-blind placebo-controlled randomized trial was conducted to investigate the safety and the efficacy of orally administered midazolam as premedication for patients undergoing elective EGD. METHODS: A total of 130 patients were randomized to receive either 7.5 mg of midazolam orally (n = 65) or a placebo (n = 65) as premedication. Outcomes measures included the anxiety score (visual analog scale) during EGD, overall tolerance, extent of amnesia, overall satisfaction, patient willingness to repeat the procedure, recovery time, and hemodynamic changes after medication. RESULTS: The median (interquartile range) anxiety score during the procedure in the midazolam group was significantly lower than that in the control group (2.0 [0-4.9] vs. 3.8 [2.1-7.95], p < 0.001). A significantly greater number of patients in the midazolam group graded overall tolerance as "excellent or good" (70.8% vs. 49.2%, p = 0.012) and reported a partial to complete amnesia response (52.3% vs. 32.3%, p = 0.02) when compared with the control group. Patients in the midazolam group were more willing to repeat the procedure if necessary (89.2% vs. 69.2%, p = 0.005). The median (interquartile range) recovery time was significantly longer in the midazolam group than in the control group (5 [5-15] minutes vs. 5 [5-10] minutes, p = 0.014). There were no statistically significant differences in satisfaction score and hemodynamic changes between groups. CONCLUSIONS: Premedication by oral administration of midazolam is a safe and an effective method of sedation that significantly reduces anxiety and improves overall tolerance for patients undergoing EGD.     

Complications after outpatient upper GI endoscopy in children: 30-day follow-up

OBJECTIVE: Upper GI endoscopy (UGE) is a common procedure performed for evaluation and treatment of various upper GI tract disorders in children. Limited comprehensive data are available on the complications of UGE in adults and particularly in children. The goals of this study were to identify complications and adverse events reported by patients and their parents after outpatient UGE under general anesthesia (GA). METHODS: Pediatric patients who underwent outpatient UGE under GA between April, 2000 and April, 2001 at the James Whitcomb Hospital for Children were identified. The interviewer obtained verbal consent and performed standardized telephone interviews 30 days after the outpatient UGE. RESULTS: A total of 393 patients participated in this survey. Of the patients, 165 (42%) had one or more complications or adverse events. The most common ones reported by patients or parents 30 days after the UGE under GA were sore throat or hoarseness (34.6%), fatigue (6.6%), cough (4.1%), headache (3.3%), excessive gas or burping (2.8%), nausea (2.5%), emesis (2.3%), abdominal pain (2%), fever (2%), behavior problems (1.8%), upper respiratory symptoms (1.3%), excessive drowsiness (0.5%), nosebleed (0.3%), perioral rash (0.3%), and chest pain (0.3%). Ten of 165 patients with complications or adverse events after UGE sought medical assistance. CONCLUSIONS: Approximately one third of pediatric patients complained of sore throat or hoarseness after UGE under GA. All other reported complications or adverse events were infrequent. We conclude that UGE under GA is safe and well tolerated in pediatric patients.     

Ketorolac improves recovery after outpatient anorectal surgery

PURPOSE: The purpose of this study was to evaluate the effectiveness of ketorolac combined with local anesthetics for anorectal surgery. METHODS: From June 1998 through March 1999, 123 outpatients undergoing anorectal surgery were entered into a prospective, randomized, double-blinded study involving three treatment groups. All patients received intravenous sedation consisting of fentanyl and a propofol infusion, with a local anesthesia mixture of lidocaine, bupivacaine, and bicarbonate. Group A (41 patients) received placebo (saline) injections. Group B (41 patients) received 60 mg of intravenous ketorolac at the onset of the procedure, and Group C (41 patients) received 60 mg of ketorolac mixed with the local anesthetic. Data were analyzed using analysis of variance and chi-squared tests. RESULTS: All groups had similar demographic characteristics and operative procedures. Twenty-nine of the 123 patients were human immunodeficiency virus-positive. There was no difference in operative or anesthesia time. Anesthesia and fluids given were similar in across groups. A significantly higher percentage of Group A patients had pain (34 percent) and required additional oral analgesia (20 percent) in the Day Surgery Unit. Only 5 percent of Group B and Group C patients complained of pain, with oral analgesics given to 2 percent of Group B and none in Group C. Voiding difficulties were more common in Group A patients, one patient requiring catheterization. CONCLUSION: The addition of ketorolac (60 mg), either intravenous or injected with local anesthetics, reduces voiding problems and significantly decreases postoperative analgesic requirements in outpatients undergoing anorectal surgery.Read at The American Society of Colon and Rectal Surgeons' 100th Anniversary and Tripartite Meeting, Washington, D.C., May 1 to 6, 1999.     

Trazodone for sleep disturbance after alcohol detoxification: a double-blind, placebo-controlled trial

Background:  Trazodone is a commonly prescribed off-label for sleep disturbance in alcohol-dependent patients, but its safety and efficacy for this indication is unknown.
Methods:  We conducted a randomized, double-blind, placebo-control trial of low-dose trazodone (50 to 150 mg at bedtime) for 12 weeks among 173 alcohol detoxification patients who reported current sleep disturbance on a validated measure of sleep quality or during prior periods of abstinence. Primary outcomes were the proportion of days abstinent and drinks per drinking day over 6-months; sleep quality was also assessed.
Results:  Urn randomization balanced baseline features among the 88 subjects who received trazodone and 85 who received placebo. The trazodone group experienced less improvement in the proportion of days abstinent during administration of study medication (mean change between baseline and 3 months: −0.12; 95% CI: −0.15 to −0.09), and an increase in the number of drinks per drinking day on cessation of the study medication (mean change between baseline and 6 months, 4.6; 95% CI: 2.1 to 7.1). Trazodone was associated with improved sleep quality during its administration (mean change on the Pittsburgh Sleep Quality Index between baseline and 3 months: −3.02; 95% CI: −3.38 to −2.67), but after it was stopped sleep quality equalized with placebo.
Conclusions:  Trazodone, despite a short-term benefit on sleep quality, might impede improvements in alcohol consumption in the postdetoxification period and lead to increased drinking when stopped. Until further studies have established benefits and safety, routine initiation of trazodone for sleep disturbance cannot be recommended with confidence during the period after detoxification from alcoholism.     

The role of flumazenil in outpatient transesophageal echocardiography.

BACKGROUND: Benzodiazepines used for transesophageal echocardiography (TEE) sedation may be associated with postprocedural psychomotor effects that are undesirable. HYPOTHESIS: We hypothesize that flumazenil can reverse cognitive and motor effects from benzodiazepine, promoting earlier return to baseline function. METHODS: We prospectively evaluated the cognitive and motor function of patients who did or did not receive flumazenil following TEE. Patients' gait, level of drowsiness, and recall of items learned before and after benzodiazepine administration were evaluated before TEE, as well as immediately and 30 min after the procedure. RESULTS: Of 207 patients (123 men and 84 women), 93 (45%) were given flumazenil 0.2 or 0.4 mg intravenously, and 113 (55%) were not. The baseline characteristics of the patients who received flumazenil were not significantly different from those who did not receive flumazenil, with the exception of a higher mean dosage of midazolam administered to the flumazenil group. In addition, patients in the flumazenil group appeared more drowsy immediately following TEE. When adjusted for age and midazolam dosage, there were no differences, at any time, between the two groups in gait or recall of items learned prior to sedation. however, at 30 min following TEE, the flumazenil group was able to recall a larger number of new items learned immediately after the procedure (1.92/3 vs. 1.61/3, p = 0.02) than did patients in the group not receiving flumazenil. No adverse effects were encountered in any patient. CONCLUSION: Flumazenil appears safe and effective in reversing anterograde amnesic effects of benzodiazepine following TEE, but has no effects on retrograde amnesia and does not promote earlier return of motor function to baseline. It is useful in clinical situations where high dosages of benzodiazepine have been used and/or excessive drowsiness is evident following TEE. Routine use of the drug, however, is not necessary.     

Randomized placebo-controlled trial on local applications of opioids after hemorrhoidectomy

Background  

Hemorrhoidectomy is associated with considerable postoperative pain. This study assessed whether a small dose of morphine or oxycodone administered in the embedded sponge set in the anus at the end of a hemorrhoidectomy intervention reduced postoperative pain.     

Prospective analysis of complications 30 days after outpatient upper endoscopy.

OBJECTIVE: The aim of this study was to compare complication rates reported by patients 30 days after outpatient upper endoscopy with those discussed at our monthly morbidity and mortality conference. We also intended to establish which complications were reported most frequently 30 days after upper endoscopy, and which patients or procedures involved the highest risk. METHODS: Trained interviewers performed standardized telephone interviews on consecutive outpatients undergoing upper endoscopy over a 1-yr period. Patients were queried regarding potential events related to their upper endoscopy in the 30 days subsequent, including symptoms, emergency room (ER) and/or physician visits, and hospitalizations. The indications, findings, and therapies were reviewed from endoscopic reports. RESULTS: A total of 473 patients were contacted 30 days after outpatient upper endoscopy and agreed to participate in our study. The most common complications reported by patients at 30 days were sore throat (9.5%) and abdominal discomfort (5.3%). Twelve patients (2.5%) required an ER/physician visit and five patients (1.1%) required hospitalization. The minority of both ER/physician visits (16.7%) and hospitalizations (40%) were discussed at our monthly morbidity and mortality conferences. CONCLUSIONS: More complications were reported by patients 30 days after outpatient upper endoscopy than were discussed at our monthly morbidity and mortality conferences. The most frequent complications reported by patients were sore throat and abdominal pain. The minority of ER/physician visits and hospitalizations were discussed at our morbidity and mortality conferences.     

Appropriateness of outpatient gastrointestinal endoscopy in a non-academic hospital

AIM:To assess the appropriate use and the diagnostic yield of upper gastrointestinal endoscopy and colonoscopy in this subgroup of patients.METHODS:In total,789 consecutive outpatients referred for gastrointestinal(GI) endoscopy [381 for esophagogastroduodenoscopy(EGD) and 408 for colonoscopy] were prospectively enrolled in the study.The American Society for Gastrointestinal Endoscopy(ASGE) guidelines were used to assess the relationship between appropriateness and the presence of relevant endoscopic f indings.RESULTS:The overall inappropriate rate was 13.3%.The indications for EGD and colonoscopy were,respectively,appropriate in 82.7% and 82.6% of the exams,uncertain in 5.8% and 2.4% and inappropriate in 11.5% and 15%.The diagnostic yield was signif icant higher forEGDs and colonoscopies judged appropriate and uncertain when compared with those considered inappropriate(EGD:36.6% vs 36.4% vs 11.4%,P = 0.004;Colonoscopy:24.3% vs 20.0% vs 3.3%,P = 0.001).Of the 25 malignant lesions detected,all but one was detected in exams judged appropriate or uncertain.CONCLUSION:This study shows a good adherence to ASGE guidelines by the referring physicians and a significant increase of the diagnostic yield in appropriate examinations,namely in detecting neoplastic lesions.It underscores the importance that the appropriateness of the indication assumes in assuring high-quality GI endoscopic procedures.