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Remimazolam provides adequate sedation during colonoscopy
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Remimazolam provided adequate sedation in patients undergoing colonoscopy with a superior success rate compared with midazolam, according to the results of a phase 2b trial.
“Remimazolam is a benzodiazepine developed to provide sedative effects with a short half-life (terminal elimination half-life 0.75 hours compared with 4.29 hours for midazolam) translating into a quick onset and offset of effect,” the researchers wrote. “This ester-based drug is rapidly hydrolyzed in the body by tissue esterases to an inactive carboxylic acid metabolite. To date, three clinical trials for procedural sedation have been completed and reported, and this manuscript describes the fourth.”
The researchers performed a double blind, randomized, parallel-group, active-controlled study involving 162 patients aged 18 to 70 years scheduled for a routine colonoscopy, whom they randomly assigned to one of four treatments: 8 mg, 7 mg or 5 mg remimazolam (Paion AG) or 2.5 mg midazolam for induction of sedation. Patients received supplemental oxygen and 100 µg fentanyl before the procedure, which began once suitable sedation was achieved. Sedation was maintained by bolus top-ups of 3 mg, 2 mg and 3 mg for the three remimazolam groups, respectively, and 1 mg midazolam, or fentanyl as required by depth of sedation.
Procedural success served as the primary efficacy endpoint, defined by Modified Observer’s Assessment of Alertness/Sedation scores, completion of the procedure, no requirement of alternative or rescue sedative, and no manual or mechanical ventilation.
All of the remimazolam dose groups had greater procedural success compared with the midazolam group (each > 92% vs. 75%; P = .007), and there was a trend toward increasing success rate with lower doses of remimazolam. No groups required mechanical ventilation, and all procedural failures were caused by requiring a rescue sedative.
“The remimazolam 5.0/3.0 mg-dose group demonstrated the highest efficacy rate and at the same time the best safety profile, indicating that this initial dose, combined with top-up doses of up to 3 mg should be pursued in future studies,” the researchers concluded. “This study’s success in documenting both efficacy as well as a good safety profile warrants further investigation through confirmatory phase 3 studies.” – by Adam Leitenberger
Disclosure: Several researchers report they are employees of or consultants for Paion, which funded the study.
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