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

NCT05164159 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2022-11-07

No results posted yet for this study

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

Interventions

DRUG

propofol group

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

remimazolam group

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.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Bon-Nyeo Koo · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-20
Primary Completion
2022-08-22
Completion
2022-08-22

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05164159 on ClinicalTrials.gov