A randomized double-blinded multicenter comparison of remifentanil versus fentanyl when combined with isoflurane/propofol for early extubation in coronary artery bypass graft surgery

We compared a fentanyl/isoflurane/propofol regimen with a remifentanil/isoflurane/propofol regimen for fast-track cardiac anesthesia in a prospective, randomized, double-blinded study on patients undergoing elective coronary artery bypass graft surgery. Anesthesia was induced with a 1-min infusion of 0.5 mg/kg propofol followed by 10-mg boluses of propofol every 30 s until loss of consciousness. After 0.2 mg/kg cisatracurium, a blinded continuous infusion of remifentanil at 1 microg. kg(-1). min(-1) or the equivalent volume rate of normal saline was then started. In addition, a blinded bolus syringe of 1 microg/kg remifentanil or 10 microg/kg fentanyl, respectively, was given over 3 min. Blinded remifentanil, 1 microg. kg(-1). min(-1) (or the equivalent volume rate of normal saline), together with 0.5% isoflurane, were used to maintain anesthesia. Significantly more patients (P < 0.01) in the fentanyl regimen experienced hypertension during skin incision and maximum sternal spread compared with patients in the remifentanil regimen. There were no differences between the groups in time until extubation, discharge from the surgical intensive care unit, ST segment and other electrocardiogram changes, catecholamine levels, or cardiac enzymes. The remifentanil-based anesthetic (consisting of a bolus followed by a continuous infusion) resulted in significantly less response to surgical stimulation and less need for anesthetic interventions compared with the fentanyl regimen (consisting of an initial bolus, and followed by subsequent boluses only to treat hemodynamic responses) with both drug regimens allowing early extubation. IMPLICATIONS: Both fentanyl and the newer opioid remifentanil, when each is combined with isoflurane and propofol, allowed for fast-track cardiac anesthesia. The remifentanil regimen used in this study resulted in significantly less hemodynamic response to surgical stimulation.     

Aprotinin versus placebo in major orthopedic surgery: a randomized,double-blinded,dose-ranging study

We conducted a prospective, multicenter, double-blinded, dose-ranging study to compare the risk/benefit ratio of large- and small-dose aprotinin with placebo after major orthopedic surgery. Fifty-eight patients were randomized into three groups: Large-Dose Aprotinin (4 M kallikrein inactivator unit [KIU] bolus before surgery followed by a continuous infusion of 1 M KIU/h until the end of surgery), Small-Dose Aprotinin (2 M KIU bolus plus 0.5 M KIU/h), and Placebo. Bleeding was measured and calculated. Bilateral ascending venography was systematically performed on the third postoperative day. Measured and calculated blood loss decreased in the Large-Dose Aprotinin group (calculated bleeding, whole blood, hematocrit 30%, median [range], 2,023 mL [633-4,113] as compared with placebo, 3,577 mL [1,670-21,758 mL]). The total number of homologous and autologous units was also significantly decreased in the Large-Dose Aprotinin group (2 U [0-5 U] as compared with placebo, 4 U [0-42 U]). No increase in deep vein thrombosis or pulmonary embolism was observed in the aprotinin groups. Large-dose aprotinin was safe and effective in dramatically reducing the measured and calculated bleeding and the amount of transfused red blood cell units after major orthopedic surgery. IMPLICATIONS: Large doses of aprotinin decrease blood loss and transfusion amount in major orthopedic surgery.     

The efficacy and resource utilization of remifentanil and fentanyl in fast-track coronary artery bypass graft surgery: a prospective randomized, double-blinded controlled, multi-center trial

We compared (a) the perioperative complications; (b) times to eligibility for, and actual time of the following: extubation, less intense monitoring, intensive care unit (ICU), and hospital discharge; and (c) resource utilization of nursing ratio for patients receiving either a typical fentanyl/isoflurane/propofol regimen or a remifentanil/isoflurane/propofol regimen for fast-track cardiac anesthesia in 304 adults by using a prospective randomized, double-blinded, double-dummy trial. There were no differences in demographic data, or perioperative mortality and morbidity between the two study groups. The mini-mental status examination at postoperative Days 1 to 3 were similar between the two groups. The eligible and actual times for extubation, less intense monitoring, ICU discharge, and hospital discharge were not significantly different. Further analyses revealed no differences in times for extubation and resource utilization after stratification by preoperative risk scores, age, and country. The nurse/patient ratio was similar between the remifentanil/isoflurane/propofol and fentanyl/isoflu-rane/propofol groups during the initial ICU phase and less intense monitoring phase. Increasing preoperative risk scores and older age (>70 yr) were associated with longer times until extubation (eligible), ICU discharge (eligible and actual), and hospital discharge (eligible and actual). Times until extubation (eligible and actual) and less intense monitoring (eligible) were significantly shorter in Canadian patients than United States' patients. However, there was no difference in hospital length of stay in Canadian and United States' patients. We conclude that both anesthesia techniques permit early and similar times until tracheal extubation, less intense monitoring, ICU and hospital discharge, and reduced resource utilization after coronary artery bypass graft surgery. IMPLICATIONS: An ultra-short opioid technique was compared with a standard fast-track small-dose opioid technique in coronary artery bypass graft patients in a prospective randomized, double-blinded controlled study. The postoperative recovery and resource utilization, including stratification of preoperative risk score, age, and country, were analyzed.     

Ketamine as an adjunct to fentanyl improves postoperative analgesia and hastens discharge in children following tonsillectomy - a prospective, double-blinded, randomized study

Objective: To evaluate the effect of ketamine, as an adjunct to fentanyl, on postoperative analgesia and duration of Postoperative Care Unit (PACU) stay, in children undergoing tonsillectomy. Background: Ketamine, as an N‐methyl‐d ‐aspartate antagonist, has been recognized to have an opioid sparing effect. In addition, it does not depress respiration or affect airway tone. Hence, addition of ketamine could be potentially beneficial in children undergoing tonsillectomy, due to the high incidence of sleep apnea in these patients. Methods: In a double blinded, randomized trial, 60 ASA status I and II children between 2 and 7 years of age, scheduled to undergo elective tonsillectomy were recruited. They were randomly assigned to one of four groups to receive fentanyl 1 mcg·kg^?1 (F1 group), fentanyl 2 mcg·kg^?1 (F2 group), ketamine 0.5 mg·kg^?1 (K group), or fentanyl 1 mcg·kg^?1 plus ketamine 0.5 mg·kg^?1 (FK group) pre‐incision. Postoperative pain was scored on arrival to the PACU and at 30, 60, and 90 min thereafter. Any incidence of nausea/vomiting and time to discharge from the PACU were also recorded. Results: Important predictors found for postoperative pain on arrival to the recovery room are the group (P = 0.02) and duration of surgery (P = 0.02). Least square means and standard errors of pain scores on PACU arrival were 4.87±0.69, 3.04±0.68, 2.10±0.68 and 2.03±0.69 for F1, F2, K and FK groups, respectively. On group‐wise comparison adjusted for surgical time, significant difference was detected between F1 and K (P = 0.02), and F1 and FK (P = 0.0048) groups. Marginal significance was detected in duration of PACU stay among groups (P = 0.08); F2 and FK group had a shorter PACU stay than F1 (P = 0.05 and 0.04 respectively). No significant difference was detected in the need for supplemental analgesia. Conclusion: We conclude that the administration of ketamine 0.5 mg·kg^?1 with 1 mcg·kg^?1 fentanyl in children undergoing tonsillectomy may improve postoperative pain control without delaying home discharge.     

A comparison of remifentanil and fentanyl in patients undergoing surgery for intracranial mass lesions

We compared the effects of remifentanil versus fentanyl during surgery for intracranial space-occupying lesions. Patients were randomly assigned to receive either remifentanil (0.5 microg. kg(-1). min(-1) IV during the induction of anesthesia reduced to 0.25 microg. kg(-1). min(-1) after endotracheal intubation; n = 49) or fentanyl (dose per usual practice of the anesthesiologist; n = 54). Anesthesia maintenance doses of isoflurane, nitrous oxide, and opioid were at the anesthesiologist's discretion for both groups. There were no differences between opioid groups for the frequency of responses (hemodynamic, movement, and tearing) to intubation, pinhead holder placement, skin incision, or closure of the surgical wound. Adverse event frequencies were similar between groups. Times to follow verbal commands (P < 0.001) and tracheal extubation (P = 0. 04) were more rapid for remifentanil. The percentage of patients with a normal recovery score (were alert or arousable to quiet voice, were oriented, were able to follow commands, had motor function unchanged from their preoperative evaluation, were not agitated, and had modified Aldrete Scores of 9-10) at 10 min after surgery was more for remifentanil (45% vs 18%; P = 0.005). By 20 min, no difference between groups existed (P = 0.27). Anesthesiologists used more isoflurane in the fentanyl group (4.22 vs 1.93 minimum alveolar anesthetic concentration hours). Neurosurgeons, blinded to treatment group, favored the use of remifentanil. Similar frequencies of light anesthesia responses and other adverse events suggest that intraoperative depths of anesthesia were similar in the two groups. Under these conditions, emergence was more rapid with remifentanil. This is consistent with the necessity for less isoflurane use in the remifentanil group and the intrinsic rapid clearance of this opioid. IMPLICATIONS: Patients given remifentanil-based anesthesia for craniotomy had faster recovery times from anesthesia than did those given fentanyl-based anesthesia.     

Hemodynamics and emergence profile of remifentanil versus fentanyl prospectively compared in a large population of surgical patients

STUDY OBJECTIVE: To compare the responses to, and hemodynamics associated with surgical stress, recovery profiles, and anesthesiologists' satisfaction following balanced general anesthesia using either remifentanil or fentanyl in a large-scale population. DESIGN: Prospective, 1:1 single blind, randomized, controlled effectiveness study in which patients received either remifentanil or fentanyl in combination with a hypnotic-based anesthesia regimen of either isoflurane or propofol. SETTING: Multicenter study including 156 hospitals and ambulatory surgery facilities. PATIENTS: 2,438 patients (1,496 outpatients and 942 inpatients), 18 years of age or older, scheduled for elective surgeries under general endotracheal anesthesia, with an expected duration of unconsciousness > or =30 minutes. INTERVENTIONS: Patients were randomized to receive either intravenous (IV) remifentanil (0.5 microg/kg/min for induction and intubation, with the infusion rate decreased to 0.25 microg/kg/min after intubation) or IV fentanyl (administered according to anesthesiologists' usual practice) as the opioid during surgery. Concomitant hypnotic drugs were either propofol and/or isoflurane (with or without nitrous oxide) titrated according to protocol. Transition analgesia with either morphine or fentanyl was given to the remifentanil patients and, at the anesthesiologists' discretion, in the fentanyl patients. MEASUREMENTS: Vital signs, adverse events, and emergence profiles were assessed and recorded. Recovery profile was assessed by recording time spent in the postanesthesia care unit and step-down recovery unit, number and timing of adverse events, timing and dosage of rescue medications, and time to eligibility for discharge (to home or to hospital room). Anesthesiologists' satisfaction with the anesthetic regimen was assessed at the end of surgery. MAIN RESULTS: Remifentanil-treated patients exhibited lower systolic and diastolic blood pressures (by 10-15 mmHg) and lower heart rates (by 10-15 bpm) intraoperatively compared to the fentanyl-treated patients. This difference promptly disappeared on emergence. Remifentanil-treated patients responded to verbal command, left the operating room, and (for outpatients) were discharged home sooner than fentanyl-treated patients. Anesthesiologists rated the predictability of response to intraoperative titration, assessment of hemodynamic profiles, and the quality of anesthesia higher in the remifentanil-treated patients. CONCLUSIONS: This study confirms previous observations on the hemodynamic properties associated with remifentanil and extends these to a wider context than previously reported. These characteristics provide clinicians with an alternative in opioid-based anesthesia.     

Remifentanil,fentanyl, and cardiac surgery: a double-blinded,randomized, controlled trial of costs and outcomes

Remifentanil may be beneficial in patients undergoing coronary artery bypass graft surgery, by promoting hemodynamic stability, reducing drug requirements, and attenuating the neurohumoral "stress response." We enrolled 77 cardiac surgical patients in a double-blinded, randomized trial and randomly allocated them to one of three groups: remifentanil infusion at 0.83 micro g. kg(-1). min(-1) (Group R); fentanyl bolus, small dose, at 12 micro g/kg (Group FLD); and fentanyl bolus, moderate dose, at 24 micro g/kg (Group FMD). We found a significant difference in the median time to tracheal extubation: Group FLD, 6.5 h; Group R, 7.3 h; and Group FMD, 9.7 h (P = 0.025). Group R patients had similar times to those of Groups FLD (P = 0.14) and FMD (P = 0.30). Group FLD patients had a longer length of hospital stay (P = 0.030). Patients in Group R had a significantly infrequent rate of hypertension but a frequent rate of hypotension (P < 0.01). The urinary cortisol excretion was larger in Group FLD patients (P < 0.0005), and urine flow was smaller (P < 0.0005). Remifentanil was associated with a propofol dose reduction (P = 0.0005) and a concomitant higher bispectral index (P = 0.032). Three Group FLD patients, but none in groups FMD and R, had postoperative myocardial infarctions (P = 0.032). Remifentanil has larger drug acquisition costs but does not increase the total hospital costs associated with cardiac surgery. IMPLICATIONS: Remifentanil did not significantly reduce the duration of tracheal intubation after cardiac surgery. Remifentanil, when compared with fentanyl (total doses of approximately 15 and 28 micro g/kg), blunts the hypertensive responses associated with cardiac surgery but is associated with more hypotension; when compared with fentanyl 15 micro g/kg, remifentanil reduces cortisol excretion. Larger-dose opioids (remifentanil 0.85 micro g. kg(-1). min(-1) or fentanyl 28 micro g/kg) were associated with a decreased rate of myocardial infarction after cardiac surgery.     

Comparison of remifentanil versus ketamine for paediatric day case adenoidectomy

Few studies exist of using remifentanil and intravenous ketamine for anaesthetic induction in paediatric day case anaesthesia. Therefore, we studied 75 unpremedicated ASA I-II children (age 1-7 years) who were randomly assigned in a double-blind fashion to receive either remifentanil (1 microgram/kg), ketamine (0.7 mg/kg) or placebo before the anaesthetic induction. Anaesthesia was induced with propofol and maintained with O2-N2O-sevoflurane. Induction characteristics, recovery times and the need for postoperative analgesia were evaluated. The required induction dose of propofol was lower in the groups receiving remifentanil and ketamine compared with the group receiving placebo. After tracheal intubation heart rate and blood pressure were better attenuated with remifentanil than with ketamine or placebo. In the recovery room children in the placebo group required more doses of oxycodone than the other two groups but this did not reach statistical significance. There were no differences between the groups in achieving predetermined recovery end-points, attaining full points on the Steward score or in the well being at home. In conclusion, remifentanil provides haemodynamically more stable induction of anaesthesia compared with ketamine or placebo. Ketamine with its' longer duration of action does not prolong recovery but does not have a clear opioid-sparing effect either in the immediate postoperative period.     

Use of remifentanil in ambulatory obstetric-gynecologic surgery. A dose-effect study]

BACKGROUND: Remifentanil, a recently commercialised opioid, is characterised by a predictable and non cumulative effect which vanishes rapidly without determining side effects in the long term. These characteristics make remifentanil an ideal opioid in continuous infusion for the ambulatory surgery setting. Aim of this study was to assess the ideal dose of remifentanil, administered in bolus before propofol, in patients undergoing uterine curettage and assisted by mask ventilation in 100% oxygen. METHODS: Sixty patients, ASA status I-II, scheduled for uterine curettage, were divided into three study groups according to the bolus dose of remifentanil received before the induction agent: group A (n = 20) 1 microgram/kg; group B (n = 20) 2 micrograms/kg; group C (n = 20) 2 micrograms/kg. All patients were assisted by 100% oxygen ventilation with facial mask. During surgery the following were recorded: time to spontaneous ventilation (in case of post induction apnea); incidence of somatic and autonomic responses to surgical stress (treated with remifentanil in bolus). At the end of surgery the times to response to simple verbal commands, to discharge from the recovery room (by Aldrete score every 5') and to discharge from hospital (by PADSS score every 30') were registered. RESULTS: All patients presented post-induction apnea with a significantly more rapid return to spontaneous ventilation in group A. Six patients of group A responded to surgical stress while in groups B and C there was no need for supplementary boluses (p < 0.05). Five patients of group C were treated with atropine for bradycardia, in four of group C it was necessary to administer succinylcholine for thoracic rigidity. No significant differences regarding the anesthesia recovery times were observed. All patients were discharged from the recovery room after 10' from the end of surgery. Overall, the qualification for discharge from hospital was obtained at the second PADSS score control, except for one group A patient who incurred in metrorrhagia. CONCLUSIONS: The administration in bolus of remifentanil, before the inducing agent, permits short-term surgery in ambulatory surgery settings thanks to the rapid recovery of vital functions. Compared to the other doses, the 1.5 micrograms/kg dose guaranteed a good control over surgical stress without influencing the speed of awakening and without determining uncomfortable side effects.     

A randomized,double-blinded comparison of thoracic epidural ropivacaine,ropivacaine/fentanyl,or bupivacaine/fentanyl for postthoracotomy analgesia

Epidural ropivacaine has not been compared with bupivacaine for postthoracotomy analgesia. Eighty patients undergoing elective lung surgery were randomized in a double-blinded manner to receive one of three solutions for high thoracic epidural analgesia. A continuous epidural infusion of 0.1 mL. kg(-1). h(-1) of either 0.2% ropivacaine, 0.15% ropivacaine/fentanyl 5 micro g/mL, or 0.1% bupivacaine/fentanyl 5 micro g/mL was started at admission to the intensive care unit. We assessed pain scores (rest and spirometry), IV morphine consumption, spirometry, hand grip strength, PaCO(2), heart rate, blood pressure, respiratory rate, and side effects (sedation, nausea, vomiting, and pruritus) for 48 h. Thoracic epidural ropivacaine/fentanyl provided adequate pain relief similar to bupivacaine/fentanyl during the first 2 postoperative days after posterolateral thoracotomy. The use of plain 0.2% ropivacaine was associated with worse pain control during spirometry, larger consumption of IV morphine, and increased incidence of postoperative nausea and vomiting. Morphine requirements were larger in the ropivacaine group, with no differences between bupivacaine/fentanyl and ropivacaine/fentanyl groups. Patients in the ropivacaine group experienced more pain and performed worse in spirometry than patients who received epidural fentanyl. There was no significant difference in motor block. We conclude that epidural ropivacaine/fentanyl offers no clinical advantage compared with bupivacaine/fentanyl for postthoracotomy analgesia. IMPLICATIONS: Thoracic epidural ropivacaine/fentanyl provided adequate pain relief and similar analgesia to bupivacaine/fentanyl during the first 2 postoperative days after posterolateral thoracotomy. Plain 0.2% ropivacaine was associated with worse pain control and an increased incidence of postoperative nausea and vomiting. We conclude that epidural ropivacaine/fentanyl offers no clinical advantage compared with bupivacaine/fentanyl for postthoracotomy analgesia.     

瑞芬太尼与芬太尼对老年患者术后认知功能的影响

目的 比较瑞芬太尼和芬太尼全凭静脉麻醉对老年患者术后认知功能的影响.方法 选择ASA Ⅰ或Ⅱ级,年龄65～70岁之间择期行腹腔镜下胆囊切除术患者80例,随机分为两组:瑞芬太尼加丙泊酚靶控输注组(R组,40例);芬太尼加丙泊酚靶控输注组(F组,40例).所有患者于手术前1d及术后1、3、5d于每天16～18时进行成人韦氏量表评分(WAIS).结果 术后睁眼时间、拔管时间、复苏室停留时间R组明显短于F组(P＜0.05).拔管后Steward苏醒评分和Prince-Henry疼痛评分R组明显高于F组(P＜0.05).术后1d两组WAIS评分明显低于术前1d(P＜0.05),术后5d两组WAIS评分明显高于术后1 d(P＜0.05).两组间各时点WAIS评分比较差异无统计学意义.术中阿托品、麻黄碱、乌拉地尔用量组间差异无统计学意义.结论 瑞芬太尼和芬太尼全凭静脉麻醉用于老年患者腹腔镜手术均可引起术后一过性认知功能减低,短期内认知功能会逐渐恢复到术前水平.     

A multicentre audit of single-use surgical instruments (SUSI) for tonsillectomy and adenoidectomy

INTRODUCTION

Prions are resistant to conventional sterilisation procedures and, therefore, could be transmitted iatrogenically through re-usable adenoid and tonsil surgical instruments. Using disposable instruments would avoid the risk of transmission. We present the results of a complete audit loop using BBraun single-use surgical instruments (SUSI).

PATIENTS AND METHODS

This was a prospective multicentre audit. Surgeons were asked to fill in a standardised questionnaire recording details including postoperative complications, and evaluation of each piece of equipment compared with their own experience of conventional re-usable instruments. In the first cycle, constructive criticisms of the instruments were noted and the manufacturers modified the instruments accordingly. A second cycle of audit was subsequently undertaken.

RESULTS

A total of 86 patients were audited in the first cycle and 97 in the second cycle. Postoperative haemorrhage rate for both cycles was well within acceptable range. In the first audit cycle, surgeons generally found the Draffin rods, Boyle-Davis gag and bipolar diathermy forceps of poor quality and difficult to use. These were redesigned and, on repeat evaluation during the second audit cycle, were found to be just as good, if not better, than the re-usable instruments.

CONCLUSIONS

This study suggests that SUSI may be just as good as re-usable instruments. Furthermore, they may be more cost effective.     

Sugammadex versus neostigmine for reversal of rocuronium-induced neuromuscular blockade: A randomized,double-blinded study of thoracic surgical patients evaluating hypoxic episodes in the early postoperative period

Study objectiveThis objective of this study was to determine if reversal of rocuronium-induced neuromuscular blockade with sugammadex versus neostigmine results in a decreased number of hypoxic episodes in the early postoperative period in patients undergoing thoracic surgery with single lung ventilation.DesignSingle-center, randomized, double-blind, two-arm clinical trial.SettingOperating room and postanesthesia care unit.Patients92 subjects aged ≥18, American Society of Anesthesiologists physical status II-IV, and undergoing a thoracic operation necessitating single lung ventilation.InterventionsSubjects received either 2 mg/kg sugammadex or 50 μg/kg neostigmine with 8 μg/kg glycopyrrolate for reversal of moderate neuromuscular blockade.MeasurementsFor the first 90 min postoperatively, all episodes of hypoxia were recorded. Neuromuscular monitoring was performed with acceleromyography (TOF-Watch® SX) and the train of four (TOF) was recorded at 2, 5, 10, and 15 min after administration of the neuromuscular reversal agent.Main resultsSubjects who received neostigmine had a median of 1 episode (interquartile range IQR: 0–2.2) of hypoxia versus subjects who received sugammadex who had a median of 0 episodes (IQR: 0–1) (p = 0.009). The mean time to recovery of TOF ≥ 0.9 was significantly faster with sugammadex at 10 min (95% confidence interval CI: 5–15) compared with neostigmine at 40 min (95% CI: 15–53) (p < 0.001).ConclusionsIn thoracic surgical patients necessitating single lung ventilation, sugammadex provides faster reversal of moderate neuromuscular blockade and results in a decreased number of postoperative hypoxic episodes compared with neostigmine.