Anesthesia and analgesia
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Anesthesia and analgesia · Nov 1997
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialA randomized, blind comparison of remifentanil and alfentanil during anesthesia for outpatient surgery.
We compared remifentanil, an esterase-metabolized opioid, with alfentanil as part of balanced anesthesia with at least 0.8% isoflurane during outpatient surgery in a randomized, double-blind trial. One hundred two patients received remifentanil, and 99 patients received alfentanil. Patients who received remifentanil experienced significantly fewer stress responses to surgical stimuli (52.9% and 65.7%, P < 0.05); significantly fewer remifentanil patients responded to skin closure (11% and 22%, P < 0.05) than patients who received alfentanil. Significantly more patients in the alfentanil group required extra analgesia compared with the remifentanil group (P < 0.05). Time to respond to verbal command was shorter for alfentanil than remifentanil (median 7 min vs 9 min), and times to spontaneous respiration (median 5 min vs 8 min), adequate respiratory rate (median 6 min vs 9 min), and tracheal extubation (median 6 min vs 9 min) were significantly shorter for alfentanil in comparison with remifentanil (P < 0.05). Remifentanil patients, however, showed significantly better recovery of psychomotor and psychometric function between 30 and 90 min after surgery (P < 0.05). The incidences of hypotension intraoperatively and shivering postoperatively were significantly higher with remifentanil. No unexpected or serious adverse events were recorded with remifentanil; however, one patient who received alfentanil experienced severe recurrent respiratory depression after surgery. The metabolic profile of remifentanil allowed better intraoperative analgesia without compromising recovery. ⋯ The pharmacological profile of remifentanil, a new opioid for use in anesthesia, suggests that rapid recovery will occur after its use. This study of 200 outpatients shows that the differences suggested from kinetic studies are not always borne out in clinical practice, although later recovery variables did, in fact, favor remifentanil.
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Anesthesia and analgesia · Sep 1997
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialUse of the laryngeal mask airway as an alternative to the tracheal tube during ambulatory anesthesia.
We designed a prospective, randomized, multicenter study to compare anesthetic requirements, recovery times, and postoperative side effects when a laryngeal mask airway (LMA) was used as an alternative to the tracheal tube (TT) during ambulatory anesthesia. After induction of anesthesia with midazolam 2 mg, fentanyl 1 microg/kg, and propofol 2 mg/kg, 381 patients were randomly assigned to receive either an LMA (n = 207) or TT (n = 174) for airway management. In patients assigned to the TT group, succinylcholine 1 mg/kg or a nondepolarizing muscle relaxant was administered to facilitate tracheal intubation. Anesthesia was maintained with volatile anesthetics in combination with nitrous oxide 60% and oxygen. The average time to placement of the two airway devices (5 min) and the failure rates (1%) were similar in the two groups. Although there was a significant decrease in the intraoperative fentanyl requirement in the LMA group, the difference was of little clinical significance. Furthermore, there were no differences in the volatile anesthetic requirements. The time from end of surgery to removal of the airway device (5 min) was also similar in the two study groups. Although duration of the postanesthesia care unit stay and time to ambulation were significantly shorter in the LMA group, there were no differences in the times to "home readiness." The incidence of nausea and vomiting and the need for rescue antiemetic treatments in the postoperative period were similar in the two airway management groups. However, the incidence of postoperative sore throat was significantly greater in patients receiving the TT (versus the LMA). In conclusion, this study suggests that the LMA is a useful alternative to the TT for airway management during ambulatory anesthesia. ⋯ Use of the laryngeal mask airway can obviate the need for insertion of a tracheal tube for many ambulatory surgery procedures, and thereby decrease the incidence of postoperative sore throats.
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Anesthesia and analgesia · Sep 1997
Randomized Controlled Trial Multicenter Study Clinical TrialTreatment of postoperative nausea and vomiting with single intravenous doses of dolasetron mesylate: a multicenter trial. Dolasetron Mesylate PONV Treatment Study Group.
This study was conducted to determine the efficacy and safety of four intravenous (I.V.) doses of dolasetron, an investigational 5-HT3 receptor antagonist, for the treatment of postoperative nausea and/or vomiting (PONV) after outpatient surgery under general anesthesia. This multicenter, randomized, double-blind trial compared the antiemetic efficacy of 12.5, 25, 50, or 100 mg I.V. dolasetron with placebo over 24 h using complete response (no emetic episodes and no rescue medication), time to first emetic episode or rescue medication, and patient nausea and satisfaction with antiemetic therapy as rated by visual analog scale (VAS). Of 1557 patients enrolled, 620 patients were eligible for treatment. Complete response rates for all dolasetron doses--12.5 mg (35%), 25 mg (28%), 50 mg (29%), and 100 mg (29%)--were significantly more effective than placebo (11%, P < 0.05). There was a significant gender interaction for complete response (P < 0.01). Of the patients in the 25-mg and 100-mg dose groups, 12% and 13%, respectively, experienced no nausea (VAS score < 5 mm) versus 5% in the placebo group (P < 0.05). There were no clinically relevant changes in vital signs or laboratory values and no trends with dose for adverse events. Dolasetron is effective for treating PONV and has an adverse event profile similar to that of placebo. The 12.5-mg dose was as effective as larger doses for complete response. ⋯ Nausea and vomiting are common problems for postsurgical patients. In this study of 620 patients undergoing surgery, a 12.5-mg dose of intravenous dolasetron, a new serotonin-receptor blocker, was significantly more effective than placebo in treating established postoperative nausea and vomiting. Dolasetron 12.5 mg was as safe as placebo.
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Anesthesia and analgesia · Jul 1997
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialA comparison of oral ketorolac and hydrocodone-acetaminophen for analgesia after ambulatory surgery: arthroscopy versus laparoscopic tubal ligation.
This multicenter study compared the analgesic efficacy and side effects of ketorolac and hydrocodone-acetaminophen when administered orally after ambulatory arthroscopic or laparoscopic tubal ligation procedures. After awakening from general anesthesia, 252 patients experiencing moderate or severe postoperative pain were randomly assigned to receive one of three analgesic treatments according to a placebo-controlled, double-blind protocol. Group 1 (n = 83) received oral ketorolac 10 mg every 6 h for up to 3 days, Group 2 (n = 82) received hydrocodone 7.5 mg plus acetaminophen 750 mg every 6 h for up to 3 days, and Group 3 (n = 87) received placebo capsules followed by ketorolac 10 mg every 6 h for up to 3 days. ⋯ However, the ketorolac group scored higher in terms of overall tolerability than the hydrocodone-acetaminophen group. In conclusion, there was no difference in the efficacy between oral ketorolac and hydrocodone-acetaminophen combination in controlling pain after outpatient arthroscopic surgery procedures. Neither oral analgesic proved to be very effective after laparoscopic tubal ligation.
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Anesthesia and analgesia · May 1997
Randomized Controlled Trial Multicenter Study Clinical TrialDose-ranging study in younger adult and elderly patients of ORG 9487, a new, rapid-onset, short-duration muscle relaxant.
The purpose of this multicenter, randomized, assessorblind placebo-controlled study was to determine which of five doses of the new, rapid-onset neuromuscular relaxant, ORG 9487, provided both good to excellent tracheal intubating conditions 60 s after administration and a clinical duration of action < 20 min in 120 younger (aged 18-64 yr) and 61 elderly (aged 65-85 yr) adult patients. Anesthesia was induced with fentanyl (2-5 micrograms/kg) and thiopental (3-6 mg/kg) and maintained with N2O/O2 and a propofol infusion (50-300 micrograms.kg-1.min-1). Neuromuscular train-of-four (TOF) monitoring by electromyography (Datex Relaxograph) commenced immediately after anesthetic induction and was followed, within 30 s, by one of five doses of ORG 9487 (0.5, 1.0, 1.5, 2.0, 2.5 mg/kg) or a placebo. ⋯ Good to excellent intubating conditions at 60 s were present in most younger adult (52 of 60) and elderly (26 of 31) patients administered doses > or = 1.5 mg/kg. Mean clinical durations < 20 min were observed in adult patients at doses up to 2.0 mg/kg and in geriatric patients up to 1.5 mg/kg. Thus, doses of 1.5-2.0 mg/kg ORG 9487 enabled both rapid tracheal intubation and a short clinical duration of action in adult and elderly patients.