Remimazolam vs Propofol as an Induction Agent for Morbid Obesity Patients

Seoul National University Bundang Hospital (Other)
Overall Status
Recruiting ID

Study Details

Study Description

Brief Summary

It is known that morbidly obese patients are often accompanied by cardiovascular complications such as hypertension, cardiac hypertrophy, and diastolic dysfunction, and are known to increase the risk of hypotension during anesthesia induction. Remimazolam is widely used in Japan and the United States, and it was approved as a drug for general anesthesia and sedation in Korea in 2021. It was reported that remimazolam caused less hypotension after induction of anesthesia than propofol. However, there is no study on the use of remimazolam in patients undergoing bariatric surgery due to morbid obesity. Therefore, through this study, we plan to check whether remimazolam is safe and effective as an anesthetic-inducing agent for morbidly obese patients undergoing bariatric surgery.

Condition or Disease Intervention/Treatment Phase
  • Drug: Remimazolam besylate
Phase 4

Study Design

Study Type:
Anticipated Enrollment :
88 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Official Title:
Comparison of Remimazolam and Propofol as an Induction Agent for Morbid Obesity Patients Undergoing Laparoscopic Sleeve Gastrectomy
Actual Study Start Date :
Oct 25, 2022
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Sep 12, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Remimazolam

Anesthesia induction with remimazolam

Drug: Remimazolam besylate
Remimazolam besylate anesthesia induction

No Intervention: Propofol

Anesthesia induction with propofol

Outcome Measures

Primary Outcome Measures

  1. Hypotension event [During anesthesia induction]

    Hypotension event

Secondary Outcome Measures

  1. Induction time [During anesthesia induction]

    Induction dose administration~LOC

  2. Vasopressor (total amount) [During anesthesia induction]

    Total ephedrine dose

Eligibility Criteria


Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • =or > 20 years

  • Admission for General anesthesia for sleeve gastrectomy

Exclusion Criteria:
  • No severe adverse effect history or hypersensitivity of benzodiazepines or its additives

  • Acute alcoholic intoxication state

  • Coma or shock state due to other condition than heart problem.

  • Acute narrow-angle glaucoma

Contacts and Locations


Site City State Country Postal Code
1 Seoul national university Bundang hospital Seongnam-si Korea, Republic of 13620

Sponsors and Collaborators

  • Seoul National University Bundang Hospital


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Seoul National University Bundang Hospital Identifier:
Other Study ID Numbers:
  • B-2208-774-001
First Posted:
May 12, 2023
Last Update Posted:
May 12, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Seoul National University Bundang Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2023