Efficacy of Remimazolam with Fentanyl versus Midazolam with Fentanyl for sedation in screening colonoscopy: A randomized controlled study

Aims There is a need to improve moderate sedation for colonoscopy while maintaining safety. Remimazolam is an ultrashort-acting benzodiazepine with a favorable safety profile that might reduce recovery time and hence prove beneficial in a large clinical setting.

Aim: The aim of this project is to investigate Remimazolam with Fentanyl compared to Midazolam with Fentanyl for sedation in screening colonoscopy.

Methods A prospective, single blind, randomized, controlled superiority trial with two parallel groups with 1:1 allocation ratio in patients undergoing screening colonoscopy. 200 randomized into two groups with 100 subjects in each study arm. The primary outcome was total time from start of medication to fulfillment of the discharge criteria. Secondary outcomes were safety, need for postprocedural recovery room, patient discomfort/pain rated using NRS-11, Time to reach coecum, need for additional Fentanyl, patient satisfaction, endoscopist satisfaction measured on a scale of 1-5, Completion of the procedure [1].

The present data’s are an interim analysis before study end. The subjects assigned to the control group underwent moderate sedation using intravenous Midazolam with Fentanyl, whereas subjects assigned to the experimental group underwent moderate sedation using intravenous Remimazolam (Byfavo) with Fentanyl. In both groups the subjects initially received a standard dose of Fentanyl and any need for supplementary. For induction of sedation subjects received either 2mg Midazolam or 5mg Remimazolam and any need for additional sedative was registered.

Results A total of 125 patients (Female/male ratio 59/66, mean age 63 (range 50-78)) out of the 200 patients planned were included. Total start of medication to fulfillment of the discharge criteria for Midazolam versus Remimazolam was 36,14 versus 30,41 min. Secondary outcomes for Midazolam versus Remimazolam were: Patient discomfort 2.68 versus 2.33, time to reach coecum 7.52 versus 4.48 min, need for additional Fentanyl 25.8% versus 19%, patient satisfaction 4.15 versus 4.59, endoscopist satisfaction mean 4.30 versus 4.59, additional need for observation after the procedure 7 patients versus 1 patient (total 14 hours versus 0.5 hour)

Conclusions The present results are an interim data presentation of a randomized study that seem to favor the combination of Remimazolam with Fentanyl over Midazolam with Fentanyl for conscious sedation in screening colonoscopy. Final results will be presented at the ESGE Days.

Publication History

Article published online:
15 April 2024

• References

• 1 Rex DK, Bhandari R, Lorch DG. et al. Safety and efficacy of remimazolam in high risk colonoscopy: A randomized trial. Digestive and Liver Disease 2021; 53: 94-101