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A Comparative Analysis of the Therapeutic Efficacy of Remimazolam Tosylate and Propofol in the treatment of Painless Endoscopic Retrograde Cholangiopancreatography

A Comparative Analysis of the Therapeutic Efficacy of Remimazolam Tosylate and Propofol in the treatment of Endoscopic Retrograde Cholangiopancreatography

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080926
Enrollment
Unknown
Registered
2024-02-18
Start date
2024-02-26
Completion date
Unknown
Last updated
2024-02-19

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

Conditions

bile duct stones

Interventions

remimazolam group:remimazolam group were intravenously administered with 0.2 mg/kg of remimazolam tosylate. The initiation of endoscopy treatment commenced when the modified observer assessment of th
propofol group:propofol group received an intravenous injection of 1.5 mg/kg of propofol emulsion injection, and the initiation of endoscopy treatment occurred when the modified observer's assessment

Sponsors

Shandong Provincial Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Patients with a confirmed diagnosis of biliary and pancreatic disease; (2) All patients requiring ERCP surgery with corresponding indications for surgical treatment; (3) Patients categorized as ASA grade I or II; (4) Patients with no contraindications or allergic reactions to remimazolam tosylate, propofol, and other anesthetic drugs; (5) Informed consent was obtained from patients participating in this study; (6) Ethical approval was obtained for the implementation of the research protocol.

Exclusion criteria

Exclusion criteria: (1) Patients with severe cardiovascular or neurological disease; (2) Patients with contraindications to surgery; (3) Patients with known allergies to benzodiazepines and opioids, and patients with prolonged use of such drugs; (4) Patients with severely abnormal liver and kidney function; (5) Patients with incomplete data collection of observation indicators.

Design outcomes

Primary

MeasureTime frame
induction time;Hemodynamic Indicator Comparison(Heart rate, Mean Arterial Pressure);Number of first induction success;Recovery time;Number of additional sedatives;adverse reactions;

Secondary

MeasureTime frame
Stress Response Index(Adrenaline, Norepinephrine,Cortisol);

Countries

China

Contacts

Public ContactYongmei Sun

Shandong Provincial Third Hospital

15069027902@163.com+86 150 6902 7902

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026