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

NCT05164159 | Completed

• 1 other identifier: 4-2021-1440
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cholecystitis

Outcome Measures

Primary Outcomes (1)

• Percent of patients with hypotension event

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

Secondary Outcomes (5)

• time-weighted average of hypotension

  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

  Baseline (preoperative period) and Postoperative day 1

• Heart rate variability

  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

Study Arms (2)

propofol group

ACTIVE COMPARATOR

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

remimazolam group

EXPERIMENTAL

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

Interventions

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.

propofol group

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.

remimazolam group

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients 19 years of age or older
• the American Society of Anesthesiologists classification 1-3
• patients undergoing laparoscopic cholecystectomy at Severance Hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Bon-Nyeo Koo

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: December 20, 2021
• Study Start: February 20, 2022
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)