Changes in Autonomic Nervous Activity and Blood Pressure After Anesthesia Induction: Remimazolam Versus Propofol

PHASE3CompletedINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

December 19, 2022

Primary Completion Date

September 30, 2023

Study Completion Date

September 30, 2023

Conditions
General Anesthetics
Interventions
DRUG

Anesthesia induction with propofol

After a 10-minute-long acclimation, general anesthesia is induced with 2% propofol at the effect-site concentration of 4 μg/ml based on the Marsh Pharmacokinetic model. The effect-site concentration was maintained at 4 μg/ml until the trachea was intubated. Five minutes after the anesthesia induction, remifentanil was administered at the effect-site concentration of 4 ng/ml based on the Minto pharmacokinetic model until the trachea was intubated. With the initiation of remifentanil infusion, 1 mg/kg of rocuronium was administered following the calibration of the neuromuscular monitoring device. With the train-of-four count of 0, the trachea was intubated. Then, the effect-site concentrations of propofol and remifentanil were decreased to 3 μg/ml and 0 ng/ml, respectively, until the surgical incision was made.

DRUG

Anesthesia induction with remimazolam

After a 10-minute-long acclimation, general anesthesia is induced with a 2-minute-long infusion of remimazolam at a rate of 12 mg/kg/hr, after which the infusion rate was reduced to 1 mg/kg/hr and was maintained until the surgical incision was made. Five minutes after the anesthesia induction, remifentanil was administered at the effect-site concentration of 4 ng/ml based on the Minto pharmacokinetic model until the trachea was intubated. With the initiation of remifentanil infusion, 1 mg/kg of rocuronium was administered following the calibration of the neuromuscular monitoring device. With the train-of-four count of 0, the trachea was intubated. Then, the effect-site concentration of remifentanil was decreased to 0 ng/ml until the surgical incision was made.

Trial Locations (1)

42472

Daegu Catholic University Medical Center, Daegu

All Listed Sponsors
collaborator

Hana Pharm Co., Ltd.

INDUSTRY

lead

Daegu Catholic University Medical Center

OTHER