Randomized controlled trial assessing the effectiveness of midazolam premedication as an anxiolytic, analgesic, sedative, and hemodynamic stabilizer.

Background: Midazolam premedication is widely used before general anesthesia, but lacks clinical evidence of effectiveness. The present study aimed to evaluate the effectiveness of midazolam premedication following 4 aspects: anxiety reduction, sedation, hemodynamic stabilization, and analgesia.

Methods: In a randomized, single-blind, prospective study, a total of 128 women were allocated to the midazolam premedication group (Group P, n = 64) or the control group (Group N, n = 64). The patients were asked to complete the Beck anxiety inventory (BAI) 2 times: on the day before surgery (BS) and 30 minutes after midazolam premedication (T0). Depth of anesthesia using state entropy (SE), conventional hemodynamic data using heart rate (HR) and mean blood pressure (MBP), and analgesic profiles using surgical pleth index (SPI) were acquired at the following 4 points: T1-pre-induction, T2-prior to intubation, T3-intubation, and T4-20 minutes after intubation.

Results: No change in BAI score was observed between BS and T0 in both groups P and N (median and interquartile range [IQR], Group P: BS-4.5 [2.0-7.0], T0-4.0 [1.0-9.0], P = .603; Group N: BS-4.0 [1.0-8.5], T0-3.5 [1.0-6.0], P = .066). Midazolam premedication reduced SE at T2-4 (mean difference with 95% confidence interval [95% CI], T2-7.1 [1.6-12.6], P = .012; T3-10.4 [6.5-14.4], P < .001; T4-9.2 [5.0-13.4], P < .001). Midazolam premedication also reduced HR (mean differences [95% CI], T1-7.3 [2.5-12.1], P = .003; T3-6.6 [1.1-12.2], P = .020) and MBP at T1 and T3 (mean differences [95% CI], T1-7.3 [2.5-12.1], P = .003; T3-8.6 [1.3-15.9], P = .021), and lowered SPI at T1-3 (mean differences [95% CI]: T1-12.7 [6.1-19.4], P < .001; T2-6.0 [0.5-11.5], P = .033; T3-7.9 [1.7-14.1], P = .012).

Conclusion: Midazolam premedication did not reduce the level of anxiety. However, midazolam premedication reduced the entropy values, stabilized hemodynamics, and provided analgesia during the induction of anesthesia. The purpose of midazolam premedication needs to be reconsidered.