Skip to content

Clinical study on the efficacy and safety of nalbuphine combined with cyclopropofol in painless endoscopic examination of patients with liver cirrhosis

Clinical study on the efficacy and safety of nalbuphine combined with cyclopropofol in painless endoscopic examination of patients with liver cirrhosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100023
Enrollment
Unknown
Registered
2025-04-02
Start date
2025-04-07
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

liver cirrhosis

Interventions

ciprofol group:Patients in group H received an intravenous injection of nalbuphine at a dose of 0.05 mg/kg (drug concentration: 1 mg/ml, injection time: 10 s ± 5 s) before the endoscopic examination.
Propofol group:P group patients received intravenous injection of 0.05mg/kg nalbuphine (drug concentration 1mg/ml, injection time 10s ± 5s) before endoscopic examination. One minute later, intravenous

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 72 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (1) Clear diagnosis of liver cirrhosis, with Child-Pugh class A or B; (2) ASA classification of grade I-III, regardless of gender, aged >= 65 years; body mass index (BMI) >= 18 and = 10 and = 95% when breathing air; systolic blood pressure (SBP) >= 90 mmHg; diastolic blood pressure (DBP) >= 60 mmHg; (5) Heart rate >= 60 and <= 100 beats per minute; (6) Have a full understanding of the procedures of this study, be willing to sign the informed consent form, and strictly follow the order as required.

Exclusion criteria

Exclusion criteria: Exclusion criteria: (1) Patients with Child-Pugh class C, a history of clinical hepatic encephalopathy, or those with concurrent mental system diseases, a history of long-term use of psychiatric drugs, and cognitive impairment; (2) Severe lesions of the heart, lungs, kidneys and other systems; (3) Emergency surgery; hypovolemia, shock or coma; (4) Active gastrointestinal bleeding within the past week; (5) Patients allergic to the study drugs; (6) Patients with difficult airways; (7) Those who have been allergic to eggs, beans, opioids and their antidotes, propofol, etc.; (8) Those with contraindications to propofol, opioids and their antidotes; (9) Those who have a history or evidence of cardiovascular diseases, respiratory system diseases, mental and nervous system diseases, etc. that increase the risk during the examination process; (10) Those with a history of asthma, wheezing, sleep apnea syndrome, a history or family history of malignant hyperthermia, or a history of failed tracheal intubation found during the screening period. Those who are judged by the researcher to have a difficult airway during the screening or are determined to have difficulties in tracheal intubation operation (modified Mallampati grade IV) and are at risk of airway management; (11) Those who were found to be research subjects in drug trials within 1 month before screening during the screening period/baseline period, or those who have used lipopropofol, other sedative/anesthetic drugs and/or opioid analgesics or compound preparations containing analgesic ingredients within 72 hours before the baseline; (12) Those with contraindications to routine endoscopic procedures; Subjects for whom the researcher deems there to be any other reasonable reason for not passing the review.

Design outcomes

Primary

MeasureTime frame
The proportion of patients experiencing adverse cardiopulmonary events;

Countries

China

Contacts

Public ContactNa Qu

Shanghai Public Health Clinical Center

840431099@qq.com+86 138 4092 9060

Outcome results

None listed

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