Study of the Efficacy and Safety of Remimazolam in General Anesthesia in Adults Undergoing Cardiac Surgery
Status:
Terminated
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
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.