Comparison of Remimazolam and Propofol Effect on Oxygen Reserve During Endoscopic Retrograde Cholangiopancreatography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-11

Study Completion Date

2024-08-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 endoscopic retrograde cholangiopancreatography.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05723627

Diagnostic Gastric Endoscopy

COMPLETED NA

Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments

NCT06777758

Postoperative Complications Respiratory Depression Postoperative Nausea +2 more

RECRUITING PHASE4

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

NCT05164159

Acute Cholecystitis

COMPLETED NA

Remimazolam Versus Propofol for General Anesthesia Induction in Patients on Renin-angiotensin System Blockers Undergoing Robot-assisted Laparoscopic Prostatectomy

NCT06093971

Prostate Tumor

COMPLETED NA

Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy

NCT04727034

Hypoxia Gastric Cancer Sedation Complication +1 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatobiiliary Diseases Requiring Endoscopic Retrograde Cholangiopancreatography

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Remimazolam

Patient group who receives remimazolam for sedation during endoscopy

Group Type EXPERIMENTAL

Remimazolam besylate

Intervention Type DRUG

Patients in this group receives 0.1mg/kg of remimazolam to induce sedation prior to endoscope insertion. Remimazolam 2mg is added in case of inadequate sedation.

Propofol

Patient group who receives propofol for sedation during endoscopy

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Patients in this group receives 1mg/kg of propofol to induce sedation prior to endoscope insertion. Propofol 20mg is added in case of inadequate sedation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Remimazolam besylate

Patients in this group receives 0.1mg/kg of remimazolam to induce sedation prior to endoscope insertion. Remimazolam 2mg is added in case of inadequate sedation.

Intervention Type DRUG

Propofol

Patients in this group receives 1mg/kg of propofol to induce sedation prior to endoscope insertion. Propofol 20mg is added in case of inadequate sedation.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients (age 19\~80 yrs, ASA Class I\~III) who are scheduled for elective endoscopic retrograde cholangiopancreatograph

Exclusion Criteria

* Pregnancy Allergy to remimazolam or propofol Underlying pulmonary diseases or obstructive sleep apnea Underlying renal (serum Cr \>2mg/dL) or cardiac disease (NYHA class III or IV) Hypotension (SBP \<90mmHg) or hypoxemia (SpO2 \<90%) assessed prior to procedure

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No