The Efficacy and Safety of Remimazolam Tosilate Compared With Propofol for Endoscopic Retrograde Cholangiopancreatography Under Monitored Anesthesia Care: A Single-Center Randomized Controlled Clinical Trial

The Safety and Feasibility of Remimazolam Tosilate Compared With Propofol for Endoscopic Retrograde Cholangiopancreatography Under Monitored Anesthesia Care: a Randomized, Parallel-Controlled Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100044502

Enrollment

Unknown

Registered

2021-03-23

Start date

2021-06-01

Completion date

Unknown

Last updated

2024-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic duct stenosis and stones

Interventions

Propofol group:Propofol was used for sedation during induction and maintenance, and additional propofol was added in case of intraoperative somatic movements or shallow anesthesia.

Remimazolam tosilate Group:Remimazolam tosylate was used for sedation during induction and maintenance, and additional remimazolam tosylate was added in case of intraoperative somatic movements or sha

Eligibility

Sex/Gender

All

Age

18 Years to 89 Years

Inclusion criteria

Inclusion criteria: 1. American Society of Anesthesiologists (ASA) Class I–III; 2. Adult patients who underwent ERCP under MAC, (18 years old = age = 89 years old); 3. ERCP operation time between 30 min and 4 h.

Exclusion criteria

Exclusion criteria: 1. Allergic or contraindicated to contrast agents, remimazolam, propofol and other drugs; 2. Body mass index (BMI) = 27 kg/m2; 3. Patients with cardiac insufficiency (EF < 48%) or severe obstructive ventilatory dysfunction; 4. Pregnant or lactating women; 5. Patients with mental disorders or a history of epilepsy; 6. Patients with known or potentially difficult airways (Mallampati = ?) or high risk of regurgitation and misaspiration.

Design outcomes

Primary

Measure	Time frame
Bispectral index (BIS);Ramsay sedation scale score;Mean arterial pressure (MAP);Respiratory rate (RR);Oxygen saturation (SpO2);Heart rate (HR);Injection pain;Respiratory-related adverse events (mask pressurized oxygen, hypoxemia, tongue suffix, bronchospasm, Insert nasopharyngeal airway );Cardiovascular related adverse events(hypotension, bradycardia, arrhythmia,vasoactive drug pumping);Postoperative complications (delirium, lung infection, postoperative nausea and vomiting, dizziness or headache);	—

Measure

Time frame

Bispectral index (BIS);Ramsay sedation scale score;Mean arterial pressure (MAP);Respiratory rate (RR);Oxygen saturation (SpO2);Heart rate (HR);Injection pain;Respiratory-related adverse events (mask pressurized oxygen, hypoxemia, tongue suffix, bronchospasm, Insert nasopharyngeal airway );Cardiovascular related adverse events(hypotension, bradycardia, arrhythmia,vasoactive drug pumping);Postoperative complications (delirium, lung infection, postoperative nausea and vomiting, dizziness or headache);

—

Secondary

Measure	Time frame
Operation time; Anesthesia duration;Recovery time;Patients’body movements in surgery;Rapid gastrointestinal peristalsis;Satisfaction;	—

Countries

China

Contacts

Public ContactBiyun Zhou

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

biyun_zhou2023@163.com+86 136 6722 1256

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026