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Clinical study for nalbuphine, an opioid receptor anti-agonist, in general anesthesia without intubation for ERCP

Clinical study for nalbuphine, an opioid receptor anti-agonist, in general anesthesia without intubation for ERCP

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900020972
Enrollment
Unknown
Registered
2019-01-23
Start date
2019-02-18
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

general anesthetic

Interventions

Group 1:Injection Nalbuphine
Group 2:Injection Sulfentanyl

Sponsors

First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients planning to undergo ERCP; 2. Aged 18-80 years; 3. Body mass index (BMI) 18.5-30; 4. American Society of Anesthesiologists (ASA) is classified as Grade I-III; 5. Patients fully understand the purpose and the methods of the trial, voluntarily to participate in the clinical trial, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Abnormal operation or anesthesia history in the past; 2. Patients who had general anesthesia within 7 days before randomization; 3. There was a history of myocardial infarction and unstable angina pectoris in the first 6 weeks of screening period; 4. Severe arrhythmias such as bradycardia (heart rate < 50 beats/min), degree III atrioventricular block (excluding pacemaker patients) occurred during the screening period; 5. People with neuromuscular diseases and psychiatric disorders; 6. Hemoglobin below 90 g/L; 7. Suspected abuse of narcotic analgesics or sedatives; 8. People known to be allergic to emulsions and opioids; 9. Failure to cooperate with those who are unable to communicate; 10. Researchers believe that patients are not suitable.

Design outcomes

Primary

MeasureTime frame
blood pressure;HR;SPO2;BIS;hypotension;Hypoxemia;

Secondary

MeasureTime frame
Patient Satisfaction;The endoscopist satisfaction;

Countries

China

Contacts

Public ContactXiao-Peng Mei

First Affiliated Hospital of Xi'an Jiaotong University

meixpxp@126.com+86 18161929067

Outcome results

None listed

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