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

Not Applicable

Completed

• Conditions: Acute Cholecystitis
• Interventions: Drug: propofol group; Drug: remimazolam group

• Registration Number: NCT05164159
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2021-12-17
• Study First Posted: 2021-12-20
• Study Start: 2022-02-20
• Primary Completion: 2022-08-22
• Study Completion: 2022-08-22
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol group	propofol group	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.
remimazolam group	remimazolam group	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.

Primary Outcome Measures

Name	Time	Method
Percent of patients with hypotension event	from start of drugs to end of anesthesia on the surgery 1 day

Secondary Outcome Measures

Name	Time	Method
difference of QOR-40 score	Baseline (preoperative period) and Postoperative day 1	QoR-40 was developed by Myles et al and is a questionnaire that can examine the quality of recovery and health status of patients in the early postoperative period. Patients will also fill out a questionnaire before surgery for comparison with postoperative scores.
time-weighted average of hypotension	from start of drugs to end of anesthesia on the surgery 1 day	time-weighted average of hypotension is calculated as the depth of hypotension below a MAP of 65 mm Hg (in millimeters of mercury) × time spent below a MAP of 65 mm Hg (in minutes) divided by total duration of operation (in minutes).
dose of Norepinephrine or nicardipine	from start of drugs to end of anesthesia on the surgery 1 day
Heart rate variability	from start of drugs to end of anesthesia on the surgery 1 day	Heart rate variability is a relatively easy and non-invasive measurement method that reflects the level of balance between the sympathetic and parasympathetic nerves at every moment using EKG records.
Sedline(Psi)	from start of drugs to end of anesthesia on the surgery 1 day

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of