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Completed

NCT Number: NCT05164159

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

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.

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Key information

Conditions

Acute Cholecystitis Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol group

Drug

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

Drug

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 outcomes

  1. Percent of patients with hypotension event

    Time frame: from start of drugs to end of anesthesia on the surgery 1 day

Secondary outcomes

  1. time-weighted average of hypotension

    Time frame: from start of drugs to end of anesthesia on the surgery 1 day

    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).

  2. dose of Norepinephrine or nicardipine

    Time frame: from start of drugs to end of anesthesia on the surgery 1 day

  3. difference of QOR-40 score

    Time frame: Baseline (preoperative period) and Postoperative day 1

    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.

  4. Heart rate variability

    Time frame: from start of drugs to end of anesthesia on the surgery 1 day

    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.

  5. Sedline(Psi)

    Time frame: from start of drugs to end of anesthesia on the surgery 1 day

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 20, 2021
Registry last updated
Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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