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

Acute Cholecystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05164159
• Other study ID #: 4-2021-1440
• Status: Completed
• Phase: N/A
• Start date: February 20, 2022
• Est. completion date: August 22, 2022

Study information

• Verified date: November 2022
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: August 22, 2022
• Est. primary completion date: August 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute

Intervention

Drug:
• 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
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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients with hypotension event		from start of drugs to end of anesthesia on the surgery 1 day
Secondary	time-weighted average of hypotension	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).	from start of drugs to end of anesthesia on the surgery 1 day
Secondary	dose of Norepinephrine or nicardipine		from start of drugs to end of anesthesia on the surgery 1 day
Secondary	difference of QOR-40 score	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.	Baseline (preoperative period) and Postoperative day 1
Secondary	Heart rate variability	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.	from start of drugs to end of anesthesia on the surgery 1 day
Secondary	Sedline(Psi)		from start of drugs to end of anesthesia on the surgery 1 day