Study of the Efficacy and Safety of Remimazolam in General Anesthesia in Adults Undergoing Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT02523859|
Recruitment Status : Terminated (Poor recruitment)
First Posted : August 14, 2015
Last Update Posted : August 2, 2017
This study investigates the use of remimazolam as a sedative/hypnotic in general anesthesia. Remimazolam or propofol will be administered together with fentanyl/sufentanil/remifentanil as opioid analgesics and a neuromuscular blocker.
In total, 530 patients will be randomized. This group of 530 patients will be split randomly into 2 groups as follows:
• 106 patients will be randomized to induction with propofol plus fentanyl or sufentanil or remifentanil and a neuromuscular blocker. Throughout maintenance, the patients will receive propofol and remifentanil until weaning from the mechanical ventilation on the ICU or PACU within 24 hours after induction.
Afterwards, sedation with propofol as study medication has to be ended. If necessary, the sedation is to be continued with the hospital's own supplies (propofol or other sedative).
• 424 patients will be randomized to induction with remimazolam 6.0 mg/kg/hr together with fentanyl or sufentanil or remifentanil and a neuromuscular blocker. Throughout maintenance, the patients will receive remimazolam and remifentanil until weaning from the mechanical ventilation on the ICU or PACU within 24 hours after induction.
The primary endpoint is successful sedation is defined as a Narcotrend index of 60 or less during at least 85% of the maintenance time and no rescue sedative medication administered. The maintenance starts at arrival at the operation theater and ends with the completion of the last skin suture.
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia||Drug: Propofol Drug: Remimazolam||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Single-blind, Propofol-controlled Phase III Study Evaluating the Efficacy and Safety of Remimazolam in General Anesthesia in Adult Patients Undergoing Cardiac Surgery, Including Follow-up Sedation in the Post-anesthesia Care Unit/Intensive Care Unit|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Active Comparator: Propofol
Propofol for induction will be given as a bolus administered manually at 2.0-2.5 mg/kg slowly over approximately 1 minute. Immediately after the propofol bolus for induction has been given, propofol maintenance will be started at a dose of 3.0-9.0 mg/kg/hr and adjusted as needed.
Hypnotic drug used for anesthesia
Other Name: Diprivan
Remimazolam for induction will be given at 6.0 mg/kg/hr, which can be increased to 12.0 mg/kg/hr for one minute if loss of consciousness is not reached after 3 minutes. Immediately after the remimazolam dose for induction has been given, remimazolam maintenance will be given at 1.0 mg/kg/hr and adjusted by down-titration or up-titration to a maximum of 3.0 mg/kg/hr.
Benzodiazepine being developed for sedation and anesthesia.
Other Name: CNS7056
- Success of Procedure [ Time Frame: During maintenance phase of operation - between arrival at operation theatre and completion of last skin suture (estimated up to 24 hours). ]A narcotrend index of 60 or less during at least 85% of the maintenance time and no rescue sedative medication administered.
- Hemodynamic stability [ Time Frame: From the start of study medication until completion of the last skin suture (estimated up to 24 hours). ]Expressed as the amount of norepinephrine used.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523859
|Herzzentrum Leipzig GmbH|
|Leipzig, Germany, 04289|
|Principal Investigator:||Stefan Probst, MD||Herzzentrum Leipzig GmbH|