Skip to content

Efficacy and safety of nalbuphine hydrochloride with cyclophenol in painless gastroenteroscopy multicenter, randomized, double-blind, positive drug parallel controlled clinical study

Efficacy and safety of nalbuphine hydrochloride with cyclophenol in painless gastroenteroscopy multicenter, randomized, double-blind, positive drug parallel controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090063
Enrollment
Unknown
Registered
2024-09-23
Start date
2024-10-08
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

gastrointestinal disease

Interventions

Group A:Nalbuphine hydrochloride combined with cyclopofol
Group B:Sufentanil combined with cyclopofol

Sponsors

Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age between 18 and 75 years, regardless of gender; 2.Meet the indications for painless gastrointestinal endoscopy, such as requiring gastrointestinal endoscopy for the diagnosis or treatment of gastrointestinal diseases; 3.No history of allergies to relevant medications, especially no allergies to nalbuphine hydrochloride and cyclopropofol; 4.No severe cardiopulmonary diseases, such as heart failure, severe arrhythmias, severe respiratory diseases, etc.; 5.Basically normal liver and kidney function, with no history of severe liver or kidney dysfunction; 6.Able to understand and cooperate with the research requirements, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.History of severe cardiopulmonary diseases, such as heart failure, severe arrhythmias, severe respiratory diseases, etc.; 2.Hepatic and renal insufficiency, with a history of severe hepatic or renal diseases; 3.History of mental illnesses, such as epilepsy, schizophrenia, etc.; 4.Pregnant or lactating women; 5.Recent use of medications that may affect study results, such as analgesics, sedatives, antidepressants, etc.; 6.Inability to understand and cooperate with research requirements, such as language communication barriers, cognitive impairments, etc.; 7.Participation in any clinical trials as a subject within the past 3 months; 8.Other conditions deemed unsuitable for inclusion by the researcher.

Design outcomes

Primary

MeasureTime frame
Discomfort score;Depth of sedation;Patients satisfaction;

Secondary

MeasureTime frame
Incidence of adverse reactions;

Countries

China

Contacts

Public Contactyan zhenyi

Affiliated Hospital of Guangdong Medical University

453356755@qq.com+86 137 6300 2605

Outcome results

None listed

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