The Comparison of Hemodynamic Effects Between Remimazolam-remifentanil and Propofol-remifentanil in Patients Undergoing Laparoscopic Cholecystectomy

Yonsei University

Status: Completed

Conditions: Acute Cholecystitis

Treatments: Drug: propofol group; Drug: remimazolam group

Study type: Interventional

Funder types: Other

Identifiers

NCT05164159

4-2021-1440

Details and patient eligibility

About

This study is conducted to determine whether the occurrence of hypotension is reduced by the combined use of remimazolam and remifentanil compared to the conventional combination use of propofol and remifentanil. Patients enrolled in the study are infused continuously with either propofol or remimazolam from the start of anesthesia to the end of surgery.

Enrollment: 274 patients

Sex: All

Ages: 19 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. patients 19 years of age or older
2. the American Society of Anesthesiologists classification 1-3
3. patients undergoing laparoscopic cholecystectomy at Severance Hospital

Exclusion criteria

1. Emergency surgery,
2. patients with heart disease or arrhythmias,
3. patients undergoing concurrent surgery other than laparoscopic cholecystectomy,
4. obesity (BMI>30),
5. patients who were admitted on the surgery day,
6. foreigners,
7. illiteracy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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274 participants in 2 patient groups

propofol group

Active Comparator group

Description:

During induction, the propofol group starts the effect site concentration at 4.0 ng/ml with TCI and adjusts it to around 3.0 \~ 4.0 ng/ml after intubation to maintain an appropriate EEG-based depth of anesthesia.

Treatment:

Drug: propofol group

remimazolam group

Experimental group

Description:

Arm Description: In the remimazolam group, start remimazolam at 6 mg/kg/hr and adjust it to 1 mg/kg/hr after loss of consciousness to maintain an appropriate EEG-based depth of anesthesia.

Treatment:

Drug: remimazolam group