Hypotension after general anaesthesia induction using remimazolam or propofol in geriatric patients undergoing sevoflurane anaesthesia with remifentanil: a single-centre, double-blind, randomised controlled trial.

BACKGROUND: The occurrence of hypotension after induction of general anaesthesia is common in geriatric patients, and should be prevented to minimise perioperative complications. Compared with propofol, remimazolam potentially has a lower incidence of hypotension. This study aimed to compare the incidence of hypotension after general anaesthesia induction with remimazolam or propofol in geriatric patients. METHODS: This single-centre, double-blind, randomised trial enrolled 90 patients aged ≥80 yr who received general anaesthesia for scheduled surgery. Patients were randomised to receive remimazolam (12 mg kg-1 h-1) or propofol (0.025 mg kg-1 s-1) for anaesthesia induction, with remifentanil and sevoflurane. The presence or absence of hypertension on the ward served as the stratification factor. The incidence of hypotension after the induction of general anaesthesia, defined as a noninvasive mean arterial pressure of <65 mm Hg measured every minute from initiation of drug administration to 3 min after tracheal intubation, was the primary outcome. Subgroup analysis was performed for the primary outcome using preoperative ward hypertension, clinical frailty scale, Charlson Comorbidity Index, and age. RESULTS: Three subjects were excluded before drug administration, and 87 subjects were included in the analysis. The incidence of hypotension was 72.1% (31/43) and 72.7% (32/44) with remimazolam or propofol, respectively. No statistically significant differences (adjusted odds ratio, 0.96; 95% confidence interval, 0.37-2.46; P=0.93) were observed between groups. Subgroup analysis revealed no significant differences between groups. CONCLUSIONS: Compared with propofol, remimazolam did not reduce the incidence of hypotension after general anaesthesia induction in patients aged ≥80 yr. CLINICAL TRIAL REGISTRATION: UMIN000042587.

Hypotension after general anesthesia induction using remimazolam in geriatric patients: Protocol for a double-blind randomized controlled trial.

INTRODUCTION: In geriatric patients, hypotension is often reported after general anesthesia induction using propofol. Remimazolam is a novel short-acting sedative. However, the incidence of hypotension after general anesthesia induction using remimazolam in geriatric patients remains unclear. This study aims to compare the incidence of hypotension associated with remimazolam and propofol in patients aged ≥80 years. METHODS: This single-center, double-blind, randomized, two-arm parallel group, standard treatment-controlled, interventional clinical trial will include 90 patients aged ≥80 years undergoing elective surgery under general anesthesia who will be randomized to receive remimazolam or propofol for induction. The primary outcome is the incidence of hypotension after general anesthesia induction, occurring between the start of drug administration and 3 min after intubation. We define hypotension as mean blood pressure <65 mmHg. The primary outcome will be analyzed using the full analysis set. The incidence of hypotension in the two groups will be compared using the Mantel-Haenszel χ2 test. Subgroup analysis of the primary outcome will be performed based on the Charlson comorbidity index, clinical frailty scale, hypertension in the ward, and age. Secondary outcomes will be analyzed using the Fisher's exact test, Student's t test, and Mann-Whitney U test, as appropriate. Logistic regression analysis will be performed to explore the factors associated with the incidence of hypotension after anesthesia induction. DISCUSSION: Our trial will determine the efficacy of remimazolam in preventing hypotension and provide evidence on the usefulness of remimazolam for ensuring hemodynamic stability during general anesthesia induction in geriatric patients. TRIAL REGISTRATION: The study has been registered with UMIN Clinical Trials Registry (UMIN000042587), on June 30, 2021.