Anesthesia and analgesia
-
Anesthesia and analgesia · Apr 1998
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialA comparison of the efficacy, safety, and patient satisfaction of ondansetron versus droperidol as antiemetics for elective outpatient surgical procedures. S3A-409 and S3A-410 Study Groups.
Two identical, randomized, double-blind, placebo-controlled studies enrolled 2061 adult surgical outpatients at high risk of postoperative nausea and vomiting (PONV) to compare i.v. ondansetron 4 mg with droperidol 0.625 mg and droperidol 1.25 mg for the prevention of PONV. The antiemetic drugs or placebo were administered i.v. 20 min before the induction of anesthesia with a barbiturate compound, followed by maintenance with N2O/isoflurane/enflurane. Nausea, emetic episodes, adverse events, and patient satisfaction were analyzed for the 0 to 2 h and 0 to 24 h postoperative periods. In the 0 to 2 h postoperative period, there was a complete response (no emesis or rescue antiemetic) in 46% of subjects given placebo (P < 0.05 versus antiemetic groups), in 62% given ondansetron, in 63% given droperidol 0.625 mg, and in 69% given droperidol 1.25 mg (P < 0.05 versus ondansetron). In the 0 to 24-h postoperative period, there were no significant differences in complete response between the ondansetron and droperidol 0.625 or 1.25 mg groups; all groups remained superior to placebo. The proportion of patients without nausea during the 0 to 24 h postoperative period was greater in the antiemetic groups compared with the placebo group; however, droperidol 1.25 mg was more effective than ondansetron 4 mg or droperidol 0.625 mg (43% vs 29% or 29%, respectively). Headache incidence was higher in the ondansetron group compared with either droperidol group. Patient satisfaction scores did not differ significantly among antiemetic treatment groups, although all were superior to placebo. In conclusion, all antiemetic treatment regimens were superior to placebo for the prevention of PONV in the immediate postoperative period; however, droperidol 1.25 mg was more efficacious than ondansetron during the early recovery period (0-2 h). There were no significant differences between ondansetron and either droperidol dose for emesis prevention during the 0 to 24 h postoperative period. ⋯ More than 2000 patients at high risk of postoperative nausea and vomiting were given either placebo, ondansetron 4 mg, or droperidol 0.625 mg or 1.25 mg i.v. before the administration of general anesthesia. After surgery, the incidence of nausea, vomiting, medication side effects, and patient satisfaction were evaluated for 24 h. Droperidol 0.625 or 1.25 mg i.v. compared favorably with ondansetron 4 mg i.v. for the prevention of postoperative nausea and vomiting after ambulatory surgery.
-
Anesthesia and analgesia · Apr 1998
Randomized Controlled Trial Comparative Study Clinical TrialThe effects of adding isoproterenol to 0.125% bupivacaine on the quality and duration of epidural analgesia in laboring parturients.
This study was conducted to determine the effects of adding isoproterenol to epidural bupivacaine and sufentanil on the quality and duration of analgesia during labor. In a double blind, randomized study, 80 women were divided into two groups, receiving three doses of 0.125% bupivacaine with 7.5 microg of sufentanil and either 12.5 microg of epinephrine (EPI group) or 5 microg of isoproterenol (ISO group). Contraction pain was measured using a 100-mm visual analog scale (VAS) before epidural analgesia, at 5-min intervals for 15 min after each epidural injection, and hourly thereafter. Overall, no significant differences were observed in VAS scores between the groups. However, in the ISO group, VAS scores at 10 and 15 min after the first and second administration were significantly lower than those in the EPI group. Analgesia after each administration lasted significantly longer in patients who received epinephrine. Because of the limited duration of analgesia in the ISO group, more patients in this group received a fourth epidural administration of 0.125% bupivacaine with epinephrine 1:800,000. In conclusion, the addition of isoproterenol to bupivacaine and sufentanil induces a faster onset of analgesia and reduces the duration of analgesia compared with bupivacaine with sufentanil and epinephrine. Therefore, it is preferable to use isoproterenol only once, as a test dose, after the placement of the epidural catheter. ⋯ We analyzed the quality and duration of analgesia in laboring women after they received bupivacaine and sufentanil combined with isoproterenol or epinephrine epidurally. We found that the addition of isoproterenol to bupivacaine and sufentanil induces a faster onset of analgesia and reduces the duration of analgesia.
-
Anesthesia and analgesia · Apr 1998
Randomized Controlled Trial Clinical TrialAssessment of the safety and tolerance of 6% hydroxyethyl starch (200/0.5) solution: a randomized, controlled epidemiology study.
None of the natural and synthetic colloids currently available is free from the risk of side effects. This study was performed to contribute to the epidemiology of adverse reactions of the widely used 200/0.5 hydroxyethyl starch 6% solution (HES). Study end points were anaphylactoid reactions during preanesthesia infusion and perioperative course, and pruritus 5 days postoperatively (clinical examination and inquiry) and 8 wk after application (mailed patient questionnaire). We consecutively randomized 750 patients undergoing minor elective surgery into two parallel groups treated with HES (from two different manufacturers) and one control group treated with lactated Ringer's solution. The study population was well matched among the groups and consisted of patients of both sexes, aged 18-95 yr, ASA physical status I-III. No drug-related anaphylactoid reactions were detected during either of the observation intervals. There was no episode of pruritus after the fifth postoperative day. Incidence of pruritus after 8 wk was quite frequent but not significantly different (chi2 test, P = 0.77): 9.1% and 12.0% in the two HES groups and 11.5% in the lactated Ringer's solution control group. Except for pruritus, we conclude that HES was associated with no more complications than lactated Ringer's solution. ⋯ Anaphylactoid reactions and pruritus (itching) after the administration of a 6% hydroxyethyl starch (200/0.5) versus lactated Ringer's solution were assessed in a prospective, randomized, controlled study. There were no differences, although there was a more than 10% incidence of pruritus in both groups.
-
Anesthesia and analgesia · Apr 1998
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialA multicenter, randomized, blind comparison of amrinone with milrinone after elective cardiac surgery.
Amrinone and milrinone are phosphodiesterase inhibitors with positive inotropic effects useful for the treatment of ventricular dysfunction after cardiac surgery. Forty-four patients undergoing elective cardiac surgery at four centers received either amrinone (n = 22) or milrinone (n = 22) in a randomized, blind fashion. Immediately after separation from cardiopulmonary bypass (CPB), two bolus doses of either amrinone 0.75 mg/kg or milrinone 25 microg/kg were administered over 30 s, separated by 5 min. Hemodynamic measurements were recorded before each dose and at the end of the 10-min study. Both amrinone and milrinone increased the cardiac index (48% vs 52%, P = not significant [NS] for amrinone and milrinone, respectively). There was a small increase in mean arterial pressure (MAP) after amrinone administration (from 68 +/- 3 to 72 +/- 3 mm Hg at 10 min, P < 0.05) with no significant change in MAP after milrinone administration. Central venous pressure was significantly higher in the amrinone group at baseline and 5 min (12 vs 10 mm Hg and 11 vs 10 mm Hg, respectively; P < 0.05). Systemic and pulmonary vascular resistances decreased significantly and to a similar extent after either amrinone or milrinone administration. Phenylephrine was required in 11 of 22 patients receiving amrinone and in 11 of 22 patients receiving milrinone to maintain arterial blood pressure. The proportion of patients requiring an intravascular volume infusion (15 of 22 vs 17 of 22, P = NS) and the total fluid volume infused were similar (402 +/- 57 vs 350 +/- 49 mL, P = NS for amrinone and milrinone, respectively). Amrinone and milrinone seem to have similar hemodynamic effects after CPB, with the exception of blood pressure, although the need for vasopressor support of blood pressure did not differ. Selection between these two drugs may include nonhemodynamic considerations such as cost. ⋯ Amrinone and milrinone are drugs that improve cardiac contraction. Their effects have never been directly compared in patients. We found that amrinone and milrinone produced similar hemodynamic effects in adult patients undergoing cardiac surgery. Choice between the two drugs can be based on nonhemodynamic considerations such as cost.
-
Anesthesia and analgesia · Apr 1998
Randomized Controlled Trial Comparative Study Clinical TrialUse of the laryngeal mask airway in children with upper respiratory tract infections: a comparison with endotracheal intubation.
Several studies suggest that placement of an endotracheal tube (ETT) in a child with an upper respiratory infection (URI) increases the risk of complications. However, the development of the laryngeal mask airway (LMA) has provided anesthesiologists with an alternative means of airway management. This study was therefore designed to evaluate the use of the LMA in children with URIs and to compare it with the ETT. The study sample consisted of 82 pediatric patients (3 mo to 16 yr of age) who presented for elective surgery with an URI. Patients with URIs were randomly allocated to receive either an ETT (n = 41) or a LMA (n = 41) and were followed for the appearance and severity of any perioperative complications. The two groups were similar with respect to age, gender, anesthesia and surgery times, number of attempts at tube placement, and presenting URI symptoms. There were no differences between groups in the incidence of cough, breath-holding, excessive secretions, or arrhythmias. Although one patient in the ETT group required a muscle relaxant for laryngospasm, the overall incidence of laryngospasm was similar between the two groups. There was, however, a significantly greater incidence of mild bronchospasm in the ETT group compared with the LMA group (12.2% vs 0%, P < 0.05). The incidence of major arterial oxygen desaturation events (SpO2 <90%) during placement of the airway device was also significantly increased in the ETT group (12.5% vs 0%, P < 0.05). Furthermore, the total number of all episodes of respiratory complications, i.e., breath-holding, laryngospasm, bronchospasm, and major oxygen desaturation, was significantly greater in the ETT group (35 vs 19, P < 0.05). Despite this, all respiratory complications were easily managed, and there were no adverse sequelae. Although the risks associated with anesthetizing a child with an URI remain controversial, results from this study suggest that the LMA offers a suitable alternative to the ETT for use in children with URIs. ⋯ This study compares the use of the laryngeal mask airway with the endotracheal tube for airway management in children with upper respiratory infections. Results suggest that if the decision is made to proceed with anesthesia for the child with an upper respiratory infection, then the laryngeal mask airway provides a suitable alternative to the endotracheal tube.