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

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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