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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Cholecystitis

Intervention / Treatment
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* Drug: propofol group
* Drug: remimazolam group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients 19 years of age or older the American Society of Anesthesiologists classification 1-3 patients undergoing laparoscopic cholecystectomy at Severance Hospital Exclusion Criteria: Emergency surgery, patients with heart disease or arrhythmias, patients undergoing concurrent surgery other than laparoscopic cholecystectomy, obesity (BMI>30), patients who were admitted on the surgery day, foreigners, illiteracy

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propofol group<br>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. | Drug: propofol group<br>* 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.<br>|
| Experimental: remimazolam group<br>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. | Drug: remimazolam group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients with hypotension event |  | from start of drugs to end of anesthesia on the surgery 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| dose of Norepinephrine or nicardipine |  | from start of drugs to end of anesthesia on the surgery 1 day | 
| 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 | 
| 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 | 
| Sedline(Psi) |  | from start of drugs to end of anesthesia on the surgery 1 day |