Remimazolam vs Propofol as an Induction Agent for Morbid Obesity Patients

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05856617
• Collaborator: (none)
• Enrollment: 88
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10.6
• Patients Per Site Per Month: 8.3

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
Remimazolam; Desflurane; Morbid Obesity; Sleeve Gastrectomy; General Anesthesia	Drug: Remimazolam besylate	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT05856617
• 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: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Seoul National University Bundang Hospital: Remimazolam; Desflurane; Morbid obesity; sleeve gastrectomy
• Additional relevant MeSH terms: Obesity; Obesity, Morbid

Study Results

No Results Posted as of May 12, 2023