Back to resultsThe Comparison of Hemodynamic Effects Between Remimazolam-remifentanil and Propofol-remifentanil in Patients Undergoing Laparoscopic Cholecystectomy
Primary Purpose
Acute Cholecystitis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
propofol group
remimazolam group
Sponsored by
About this trial
This is an interventional treatment trial for Acute Cholecystitis
Eligibility Criteria
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
Sites / Locations
- Yonsei University Health System, Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
propofol group
remimazolam group
Arm 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.
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.
Outcomes
Primary Outcome Measures
Percent of patients with hypotension event
Secondary Outcome Measures
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).
dose of Norepinephrine or nicardipine
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.
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.
Sedline(Psi)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05164159
Brief Title
The Comparison of Hemodynamic Effects Between Remimazolam-remifentanil and Propofol-remifentanil in Patients Undergoing Laparoscopic Cholecystectomy
Official Title
The Comparison of Hemodynamic Effects Between Remimazolam-remifentanil and Propofol-remifentanil in Patients Undergoing Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
August 22, 2022 (Actual)
Study Completion Date
August 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
274 (Actual)
8. Arms, Groups, and Interventions
Arm Title
propofol group
Arm Type
Active Comparator
Arm 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.
Arm Title
remimazolam group
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
propofol group
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
remimazolam group
Intervention 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 Measure Information:
Title
Percent of patients with hypotension event
Time Frame
from start of drugs to end of anesthesia on the surgery 1 day
Secondary Outcome Measure Information:
Title
time-weighted average of hypotension
Description
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).
Time Frame
from start of drugs to end of anesthesia on the surgery 1 day
Title
dose of Norepinephrine or nicardipine
Time Frame
from start of drugs to end of anesthesia on the surgery 1 day
Title
difference of QOR-40 score
Description
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 Frame
Baseline (preoperative period) and Postoperative day 1
Title
Heart rate variability
Description
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.
Time Frame
from start of drugs to end of anesthesia on the surgery 1 day
Title
Sedline(Psi)
Time Frame
from start of drugs to end of anesthesia on the surgery 1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bon-Nyeo Koo
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Comparison of Hemodynamic Effects Between Remimazolam-remifentanil and Propofol-remifentanil in Patients Undergoing Laparoscopic Cholecystectomy
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