Efficacy and Safety of Remimazolam (CNS7056) Compared to Propofol for Intravenous Anesthesia Duri… (NCT03661489) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Remimazolam (CNS7056) Compared to Propofol for Intravenous Anesthesia During Elective Surgery
Germany469 participantsStarted 2018-07-24
Plain-language summary
A phase III confirmatory trial evaluating the efficacy and safety of remimazolam (CNS7056) compared to propofol for intravenous anesthesia during elective surgery in ASA Class III/IV patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
* Male or female ASA III/IV patients at least 18 years old, scheduled for an elective surgical procedure of a minimum duration of approximately 90 minutes under general anesthesia (GA) and planned to be extubated immediately post-operatively.
* Total intravenous GA with the requirement for mechanical ventilation via endotracheal tube and necessary invasive blood pressure (BP) monitoring either due to severity of illness, severity of concomitant diseases, type of surgery or decisions of the anesthesia staff.
* Patients scheduled to stay in the hospital long enough after the surgical procedure to perform all trial follow-up procedures (\~1 day)
* For female patients of childbearing potential: Negative result of a pregnancy test taken shortly before the start of the administration of the IMP as well as consent to use highly effective birth control from the last menstrual cycle prior to the start of the IMP until the end of the trial follow-up procedures. Highly effective methods of birth control include:
* Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal and transdermal
* Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable and implantable
* Intrauterine device (IUD)
* Intrauterine hormone-releasing system (IUS)
* Bilateral tubal occlusion
* Vasectomised partner (provided that the partner is the sole sexual partner of the …
What they're measuring
1
Percentage (%) of time of Narcotrend Index (NCI) values ≤ 60 during maintenance phase of general anesthesia (defined as time between the first skin incision and the completion of the last skin suture)
Timeframe: maintenance phase of general anesthesia (time between the first skin incision and the completion of the last skin suture)