Remimazolam-Alfentanil Sedation May Be Safer Than Propofol for Gastroscopy

Remimazolam-alfentanil may be a safer option for gastroscopy sedation compared with propofol-alfentanil.

A remimazolam-alfentanil sedation strategy for gastroscopy had noninferior efficacy and superior postoperative recovery and safety profiles compared with propofol-alfentanil. These findings, from a prospective, randomized, double-blind controlled trial, were published in Clinical Therapeutics.

Patients undergoing gastroscopy were enrolled for this 2-part study. In part 1 (n=32), the first patient received 5 mg/kg alfentanil and 0.3 mg/kg remimazolam 30 seconds later for colonoscopy sedation. If the patient had a failure of sedation, they were given 0.3-0.5 mg/kg propofol, and the next patient was given a 0.02 mg/kg higher dose of remimazolam until the effective sedation dose was titrated. In part 2, patients (n=168) were randomly assigned 1:1 to receive 5 mg/kg alfentanil and 0.33 mg/kg remimazolam after a 1-minute delay (n=81) or 5 mg/kg alfentanil and 2.5 mg/kg propofol after a 1-minute delay (n=80). The primary outcome was procedure success, defined as procedure completion, no rescue sedation required, and no more than 5 drug top-ups within any 15-minute period.

In part 1, 17 patients were effectively sedated and 15 were not. These groups included patients with a mean age of 43.65 and 36.40 years, the male:female ratios were 6:11 and 9:6, and average BMI was 22.17 and 22.41 kg/m2, respectively.

The dose of remimazolam that had a 50% efficacy rate was 0.25 (95% CI, 0.17-0.29) mg/kg, and a 95% effective dose was 0.33 (95% CI, 0.29-1.02) mg/kg.

The sedation strategy of remimazolam-alfentanil has noninferior efficacy, fewer adverse effects, and a better postoperative recovery process than propofol-alfentanil for patients undergoing gastroscopy.

In part 2, the remimazolam and propofol recipients had a mean age of 42.03 and 45.45 years, the male:female ratios were 35:46 and 43:37, and average BMI was 22.43 and 22.66 kg/m2, respectively.

The sedation success rates did not differ between the remimazolam and propofol strategies (97.53% vs 97.50%; P =.622), respectively.

The 2 groups did not differ for the total dose of alfentanil (P =.549), duration of gastroscopy (P =.886), recovery time (P =.190), time to discharge (P =.647), or need for ephedrine rescue (P =.269).

Propofol recipients had significantly decreased mean arterial pressure (P =.0136) and heart rate (P <.05) during the procedure compared with the remimazolam recipients, whereas heart rate was improved during the procedure compared with baseline among remimazolam recipients (P <.05).

The safety profile of remimazolam was superior to propofol, with lower rates of injection pain (3.7% vs 55.0%; P <.001), hypotension (11.0% vs 41.3%; P <.001), hypoxemia (6.2% vs 21.3%; P <.05), and dizziness (6.2% vs 17.5%; P <.05), respectively.

In a patient satisfaction survey, significantly fewer remimazolam recipients reported postdischarge drowsiness (8.6% vs 23.8%; P =.017) and disruption to work productivity the day after discharge (6.2% vs 18.8%; P =.029) compared with propofol, respectively.

The major limitation of this study was that participants were relatively young, making it unclear whether these findings may be generalizable.

“The ED95 of remimazolam was 0.33 mg/kg when it was combined with alfentanil (5 μg/kg) for gastroscopy sedation,” the study authors wrote. “The sedation strategy of remimazolam-alfentanil has noninferior efficacy, fewer adverse effects, and a better postoperative recovery process than propofol-alfentanil for patients undergoing gas- troscopy.”

References:

Shi W, Cheng Y, He H, et al. Efficacy and safety of the remimazolam-alfentanil combination for sedation during gastroscopy: a randomized, double-blind, single-center controlled trial. Clin Ther. Published online October 26, 2022. doi:10.1016/j.clinthera.2022.09.014