Comparison of remimazolam-remifentanil and propofol-remifentanil during laparoscopic cholecystectomy

Abstract

Background: Remimazolam is a novel benzodiazepine with fast onset and short half-life. We compared the effects of remimazolam and propofol on recovery profiles for general anesthesia in patients undergoing laparoscopic cholecystectomy.

Methods: We randomly assigned 108 patients to either a remimazolam (n=54) or propofol (n=54) group. Remimazolam and propofol were used for induction and maintanance of anesthesia. Following anesthesia, we recorded the time until an Aldrete score of 9 was achieved as the primary surrogate marker of complete recovery. The time to reach a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of 2 and the time from the end of anesthesia to eye opening time, recovery time of orientation, time to spontaneous breathing, extubation time, and the time required for analgesics were measured. Heart rate, blood pressure, and bispectral index were assessed before, during, and after pneumoperitoneum.

Results: We included 101 patients in the analysis. In the remimazolam group, it took longer to reach an Aldrete score of 9 after the drug infusion ended (P = 0.031). There was no difference in the time to reach MOAA/S 2 between the two groups. The time to eye opening, recovery time of orientation, and time required for analgesics were longer and heart rate was higher in the remimazolam group. Neither blood pressure, nor extubation time differed between groups.

Conclusions: Remimazolam and propofol provided safe induction and maintenance of anesthesia in patients undergoing laparoscopic cholecystectomy. The recovery time from anesthesia was longer than that with propofol. Fewer hemodynamic changes were observed with remimazolam, but further studies are needed.

Keywords: Benzodiazepine; Cholecystectomy; Laparoscopy; Propofol; Remifentanil.

Fig. 1.

CONSORT flow diagram for patient enrollment. CONSORT: consolidated standards of reporting trials.

Fig. 2.

Changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR). Baseline (T0), before intubation (T1), 1 min after intubation (T2), 5 min before CO₂ pneumoperitoneum (T3), 5 min after the start of CO₂ pneumoperitoneum (T4), 5 min before pneumoperitoneum removal (T5), and 5 min after pneumoperitoneum removal (T6). ^*P < 0.05 indicates a significant difference from the propofol group.

Fig. 3.

Changes in bispectral index (BIS). Baseline (T0), before intubation (T1), 1 min after intubation (T2), 5 min before CO₂ pneumoperitoneum (T3), 5 min after the start of CO₂ pneumoperitoneum (T4), 5 min before pneumoperitoneum removal (T5), and 5 min after pneumoperitoneum removal (T6). ^*P < 0.05 indicates a significant difference from the propofol group.