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A randomized, parallel controlled study comparing remazolam with propofol for therapeutic endoscopic retrograde cholangiopancreatography (ERCP)

Study on remazolam used in therapeutic ERCP

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049314
Enrollment
Unknown
Registered
2021-07-30
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Biliary pancreatosis

Interventions

propofol group:induction and maitainance by propofol
remimazolam group: induction and maitainance by remimazolam

Sponsors

The Second Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged >=18 years, ASA grade 1-3; 2.Therapeutic ERCP surgery was performed at an elective date, and the operation time was expected to exceed 30 minutes. The therapeutic indications of ERCP included choledocholithiasis, biliary stenosis, gallbladder cancer, pancreatic disease, and post liver transplantation, etc.; 3.Volunteer to participate in clinical study and sign written informed consent.

Exclusion criteria

Exclusion criteria: 1.Emergency ERCP examination or treatment; 2.ERCP examination alone, and the expected operation time is less than 30 minutes; 3.Abnormal head and neck pathology, head and neck surgery or radiotherapy history, suspected difficult airway; 4.Patients with full stomach and high risk of reflux and aspiration; 5.Severe cardiopulmonary insufficiency, such as EF < 40% and FEVC < 50%; Uncontrolled high blood pressure; 6.Allergic to propofol, remazolam, opioids, muscle relaxants or other sedative narcotic drugs or ingredients; 7.Pregnant women or breastfeeding women, or have pregnancy plan within the recent 1 month; 8.History of mental disorder or epilepsy; 9.Other researchers deem it inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
hemodynamics;

Secondary

MeasureTime frame
Wake up of time;The quality of waking;Satisfaction survey;Adverse events;Basic data analysis;

Countries

China

Contacts

Public ContactDai Ruping

The Second Xiangya Hospital, Central South University

xyeyyrupingdai@csu.edu.cn+86 18972924753

Outcome results

None listed

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