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Comparative Study on the Efficacy and Safety of Two Analgesic Regimens in ERCP Procedures

Comparison of Safety and Efficacy Between Oliceridine and Sufentanil Combined with Propofol for Endoscopic Retrograde Cholangiopancreatography (ERCP): A Prospective, Double-Blind, Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127428
Enrollment
Unknown
Registered
2026-06-30
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Intraoperative respiratory depression

Interventions

Oliceridine group:Slow intravenous injection of oxelidine fumarate at 0.03 mg/kg
Sufentanil group:Slow intravenous injection of sufentanil citrate at a dose of 0.15 µg/kg

Sponsors

Hangzhou First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 65 years old; 2.American Society of Anesthesiologists classification (ASA classification) = II level; 3.18 kg/m² < Body Mass Index (BMI) <30 kg/m²; 4.Voluntarily participate in this study and sign the informed consent form; 5.Patients scheduled for elective therapeutic ERCP. 6.The ERCP procedures are limited to: common bile duct stone extraction, biliary stent placement/exchange, pancreatic duct stent placement, or endoscopic sphincterotomy (EST). Patients undergoing solely diagnostic ERCP or simple contrast injection are excluded.

Exclusion criteria

Exclusion criteria: 1.There have been previous changes in the gastrointestinal anatomical structure, delayed gastric emptying, and gastric outlet obstruction. 2.Make a clear diagnosis of heart diseases (coronary heart disease, myocardial infarction, congestive heart failure, left ventricular ejection fraction < 40%, tachyarrhythmia, second or higher degree atrioventricular conduction block, sick sinus syndrome); 3.There is a history of allergic reaction to related anesthetic drugs in the past; 4.Make a clear diagnosis of lung diseases (such as asthma, bronchitis, chronic obstructive pulmonary disease, pulmonary bullae, pulmonary embolism, pulmonary edema, lung cancer, etc.); 5.Presently, there is an upper respiratory tract infection; 6.Severe liver and kidney diseases; 7.Difficult airway: The anesthesiologist before the operation assesses the presence of a difficult airway. 8.The disadvantaged groups other than the elderly and illiterate include those with mental illnesses, those with cognitive impairments, critically ill patients, pregnant women, etc. 9.Individuals who have been taking opioids for a long time or have a history of drug abuse; 10.It is expected that the surgery will last for more than 90 minutes or require multiple stages;

Design outcomes

Primary

MeasureTime frame
Respiratory depression;

Secondary

MeasureTime frame
Hypertension (an increase in blood pressure exceeding 25% of the baseline value);Postoperative adverse events;Awakening time;Postoperative pain score;The number of times the endoscope was removed due to hypoxemia;Total dosage of propofol used during the operation;Bradycardia (During anesthesia, the patient's heart rate decreases by more than 25% from its baseline value.);Subclinical respiratory depression;Number of body movements;Tachycardia (The patient's heart rate increased by more than 25% above their baseline value);Hypotension (a decrease in blood pressure exceeding 25% of the baseline value);Number of airway intervention procedures;

Countries

China

Contacts

Public ContactSun Jianliang

Hangzhou First People's Hospital

jxmzsjl@163.com+86 13958069878

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026