Effects of remimazolam combined with sufentanil on hemodynamics during anesthetic induction in elderly patients with mild hypertension undergoing orthopedic surgery of the lower limbs: a randomized controlled trial.

BACKGROUND

This randomized controlled trial was performed to observe the effect of remimazolam with sufentanil on hemodynamics during anesthetic induction in elderly patients with mild hypertension undergoing orthopedic surgery of the lower limbs.

METHODS

Sixty elderly patients were randomly assigned to undergo general anesthesia with intravenous injection of either remimazolam besylate (25 mg/vial, batch number 10T11011; Yichang Humanwell Pharmaceutical Co., Ltd., Yichang, China) at 0.2 mg/kg (Group R, n = 30) or propofol at 1.5 mg/kg (Group P, n = 30). Both injections were completed within 15 to 20 s. If the bispectral index value did not reach 40 to 60, then 0.05 mg/kg of remimazolam was added in Group P and 1 mg/kg of propofol was added in Group R. When the BIS value reached 40 to 60, sufentanil was administered at 0.3 to 0.5 µg/kg and cisatracurium was administered at 0.15 to 0.2 mg/kg in both groups. Three minutes later, tracheal intubation and controlled ventilation were performed to maintain the end-tidal carbon dioxide partial pressure at 4.5 to 5.0 kPa. The mean arterial pressure (MAP), heart rate (HR), cardiac output (CO), continuous cardiac index (CI), systemic vascular resistance (SVR), and pulse oxygen saturation were recorded before induction (T0), when the eyelash reflex disappeared (T1), immediately after endotracheal intubation (T2), 1 min after endotracheal intubation (T3), and 5 min after endotracheal intubation (T4). The disappearance time of the eyelash reflex, injection pain, hypotension, bradycardia, hiccupping, nausea and vomiting, and other adverse events were observed.

RESULTS

The MAP, HR, CO, and CI at T1, T2, T3, and T4 were significantly higher in Group R than P, while SVR was significantly lower in Group R than P (P < 0.05). In Group P, the MAP, HR, CO, and CI were significantly lower and the SVR was significantly higher at T1, T2, T3, and T4 than at T0 (P < 0.05). Adverse events occurred in 8 (20%) patients in Group R and 22 (73%) in Group P. The total incidence of adverse events was significantly lower in Group R than P (P < 0 0.001).

CONCLUSION

Remimazolam combined with sufentanil for general anesthesia induction has the advantages of small hemodynamic fluctuations, stable circulation, and few adverse reactions, making it suitable for elderly patients with mild hypertension.

TRIAL REGISTRATION

Chinese Clinical Trial Registry (ChiCTR2300069224, 10/03/2023).