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
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.
Study Type
Interventional
Primary Outcome
Percent of patients with hypotension event
Secondary Outcome
time-weighted average of hypotension
Condition
Acute Cholecystitis
Intervention
propofol group
Study Arms / Comparison Groups
propofol 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
274
Start Date
December 2021
Completion Date
January 2024
Primary Completion Date
January 2024
Eligibility Criteria
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
Gender
All
Ages
19 Years - 90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
, , [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT05164159
Organization ID
4-2021-1440
Responsible Party
Sponsor
Study Sponsor
Yonsei University
Study Sponsor
, ,
Verification Date
December 2021