Comparison of Remimazolam and Propofol Effect on Oxygenation Reservoir During Diagnostic Gastric Endoscopy

NCT05723627 | Completed DMC

• 1 other identifier: 4-2022-1369
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Propofol is one of the most commonly used sedative in endoscopic procedures, while its potency to induce respiratory depression may threaten patient safety. Remimazolam is known to less likely induce hemodynamic instability when compared to propofol, yet its favorable effects are not clearly evaluated in endoscopic procedures. Hence, this study aimed to compare hemodynamic effects of remimazolam and propofol, by evaluating oxygen reserve index (ORI) in patients scheduled for diagnostic gastric endoscopy.

Conditions

Diagnostic Gastric Endoscopy

Outcome Measures

Primary Outcomes (1)

• Incidence of Oxygen Reserve Index (ORI) drop to 0.00 during sedation

  Incidence of Oxygen Reserve Index (ORI) drop to 0.00 will be evaluated after sedative administration, until the end of endoscopic procedure.

  Evaluation begins after sedative administration until the end of endoscopic procedure.

Study Arms (2)

Remimazolam

EXPERIMENTAL

Patient group who receives remimazolam for sedation during endoscopy

Drug: Remimazolam besylate

Propofol

ACTIVE COMPARATOR

Patient group who receives propofol for sedation during endoscopy

Drug: Propofol

Interventions

Remimazolam besylate DRUG

Patients in this group receives 0.1mg/kg of remimazolam to induce sedation prior to endoscope insertion.

Remimazolam

Propofol DRUG

Patients in this group receives 0.5mg/kg of propofol to induce sedation prior to endoscope insertion.

Propofol

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (age 19\~80 yrs, ASA Class I\~III, ECOG 0\~1) who are scheduled for elective diagnostic gastric endoscopy

You may not qualify if:

• Pregnancy Allergy to remimazolam or propofol Underlying pulmonary diseases or obstructive sleep apnea Hypotension (SBP \<80mmHg) or hypoxemia (SpO2 \<90%) assessed prior to procedure

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Sung Kwan Shin

  Department of Internal Medicine, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 13, 2023
• Study Start: April 6, 2023
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

KR (1)