Remimazolam sedation safe, effective even in high-risk patients

Remimazolam achieves safe and effective sedation for colonoscopy in high-risk patients, as classified by the American Society of Anaesthesiologists (ASA) criteria, a recent study has found.

Researchers conducted a double-blind, randomized, parallel group trial including 77 ASA class III/IV patients undergoing colonoscopy. Thirty-one patients received midazolam, while 16 were given placebo; a third, open-label arm comprising 30 patients was given midazolam. The primary outcome was safety of multiple doses, determined through adverse events (AEs), vital signs, and physical exams, among others.

Treatment-emergent AEs (TEAEs) were reported in 28 remimazolam patients, yielding an incidence rate of 90.3 percent. This was higher, but not significantly so, than that in the placebo (81.3 percent; p=0.3952) and midazolam (86.7 percent; p=0.7072) groups.

Of the 28 TEAEs in the remimazolam arms, only three were considered related to the intervention. A comparable incidence of drug-related TEAEs were reported for the other study arms (p=1.00). Only one serious AE leading to study discontinuation was detected, occurring in the midazolam arm.

Remimazolam also proved superior to both comparator arms, with an overall procedural success rate of 87.1 percent, as opposed to 0.0 percent and 13.3 percent in the placebo and midazolam groups (p<0.00001 for both). Reasons for remimazolam failure included needing rescue sedation and administering too many doses.

“[R]emimazolam can be used safely and effectively in high risk ASA patients, and maintains its advantages relative to midazolam in high-risk patients,” the researchers said.