A RANDOM TRIAL COMPARING RECOVERY AFTER MIDAZOLAM-ALFENTANIL ANESTHESIA WITH AND WITHOUT REVERSAL WITH FLUMAZENIL, AND STANDARDIZED NEUROLEPT ANESTHESIA FOR MAJOR GYNECOLOGIC SURGERY

Study Objective: To compare the recovery characteristics of total intr avenous anesthesia (TIVA) using midazolam-alfentanil, with or without reversal with flumazenil to a standardized neurolept anesthesia with n itrous oxide (N2O). Design: Randomized, double-blinded clinical study. Setting: University medical center. Patients: 80 ASA physical status I and II women scheduled for major elective gynecologic surgery. Inter ventions: Patients were anesthetized with one of three different anest hetic techniques. Patients in the TIVA group with reversal received mi dazolam-alfentanil re versed with flumazenil (Group 1), the TIVA group without reversal received midazolam-alfentanil reversed with placebo (Group 2), and patients in the neurolept group received anesthesia usi ng thiopental sodium, droperidol, fentanyl, and N2O (Group 3). Measure ments and Main Results: Recovery was assessed by an observer blinded t o the treatment allocation, using a Modified Steward Recovery Score an d judgment of orientation and comprehension, collaboration and degree of sedation for the first 4 hours after extubation. Arterial blood gas es were measured 30 minutes after extubation. A questionnaire regardin g the degree of perioperative amnesia was presented to the patients 4 and 24 hours after surgery. The recovery scores were better in the TIV A group With reversal than in the other two groups from 0 to 30 minute s postoperatively. No difference between the groups could be found the reafter, although after 30 minutes some resedation occurred in the TIV A group with reversal. The median injected amount of flumazenil in Gro up 1 was 0.5 mg. Respiratory depression (breathing frequency below 10 breaths/min) was reversed with naloxone in one patient in the TIVA gro up with reversal, five patients in the TIVA group without reversal, an d no patient in the neurolept group (p < 0.001). On blood gas analysis , there was no evidence of hypoxemia or carbon dioxide retention. No d ifference was seen between the groups regarding consumption of analges ics, degree of amnesia, or patient rating of the qualify of anesthesia . One patient in Group 2, however; recorded aware ness at skin incisio n when questioned 4 hours after the operation, but could not recall th is 20 hours later. Conclusions: TIVA with midazolam and alfentanil can be used for major gynecologic surgery. Recovery in the neurolept grou p was equal to recovery in the TNA group without reversal, and flumaze nil improves the recovery after midazolam anesthesia. Overall, in comp arison with the neurolept technique no major advantage could be demons trated using TIVA with midazolam-alfentanil.