Effect of Remimazolam versus Propofol on Hemodynamics in Elderly Hypertensive Patients Undergoing Gastroenteroscopy: A Multicenter, Randomized Controlled Clinical Trial.

PURPOSE: This study aimed to compare the effects of remimazolam and propofol on hemodynamics in elderly hypertensive patients undergoing gastroenteroscopy.

METHODS

In this multicenter, single-blind, randomized clinical trial, 220 hypertensive patients (65-75 years) scheduled for gastroenteroscopy were randomly assigned to receive either remimazolam (group R, n=110; 0.3 mg/kg induction followed by 0.2-1 mg/kg/h maintenance) or propofol (group P, n=110; 1.5 mg/kg induction followed by 2-6 mg/kg/h maintenance), both combined with 0.1 μg/kg sufentanil. Flumazenil or placebo was administered for reversal. Hemodynamics were monitored via Continuous Non-Invasive Arterial Pressure (CNAP). The primary outcomes were hypotension incidence and hemodynamic parameters [mean arterial pressure (MAP), heart rate (HR), cardiac output (CO), and systemic vascular resistance (SVR)]; secondary outcomes included the incidence of other adverse events and recovery time.

RESULTS

Group R exhibited significantly lower incidences of hypotension (72.7% vs 37.3%, p < 0.001) and bradycardia (16.4% vs 7.3%, p = 0.037), alongside reduced vasopressor requirements (ephedrine: 3.760 ± 4.133 vs.1.850 ± 3.121, p < 0.001; metaraminol: 0.101 ± 0.208 vs 0.045 ± 0.144, p = 0.012). Both groups exhibited decreased MAP, CO, and SVR at the time point of endoscope entry (T1) compared to 2 minutes before anesthesia induction (T0), while HR reduction was significant only in group P (p < 0.001 vs p = 0.084 in group R). From T1 through 15 minutes post-procedure (T4), group R maintained higher MAP and HR than group P (p < 0.05). Remimazolam was associated with shorter recovery time (p < 0.001), lower rates of respiratory depression (p = 0.002), but higher rates of body movements (p < 0.001) and cough (p = 0.001).

CONCLUSION

Remimazolam provides superior hemodynamic stability and faster recovery compared to propofol in elderly hypertensive patients undergoing gastroenteroscopy, establishing it as a safer sedation option for this vulnerable patient population.

TRIAL NUMBER AND REGISTRY URL: Registration number, ChiCTR2400083757; https://www.chictr.org.cn/showproj.html?proj=214795.