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Clinical study protocol for an effective dose study of nalbuphine combined with propofol anesthesia for painless gastroscopy in elderly patients

Clinical study protocol for an effective dose study of nalbuphine combined with propofol anesthesia for painless gastroscopy in elderly patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091583
Enrollment
Unknown
Registered
2024-10-30
Start date
2023-03-15
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

Gastrointestinal surgery

Interventions

Agroup:Propofol 2mg/kg+ Nalbuphine 0.1mg/kg
B group:Propofol + Nabulphine 0.1mg/kg
C group:Propofol + Nabulphine 0.2mg/kg

Sponsors

Anhui Public Health Clinical Center, the First Affiliated Hospital of Anhui medical University North District
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Elderly patients, aged 65-80 years, scheduled for elective painless gastroscopy; 2.Body mass index BMI 18-25kg/m2, ASA II-III; 3.Gender is not limited, voluntary subjects and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe dysfunction in cardiopulmonary,liver,kidney and brain; 2. History of allergy to soy, milk, propofol, sufentanil or local anesthetic drugs; 3. History of alcohol abuse or drug dependence; 4. Severe audiovisual impairment or other factors lead to communication difficulties.

Design outcomes

Primary

MeasureTime frame
Propofol ED50 ;Nabulphine ED50 ;

Secondary

MeasureTime frame
Respiratory depression;Blood pressure, heart rate, pulse oxygen saturation;The propofol injection hurts;Duration of gastroscopy;Total amount of propofol;Recovery time;Orientation recovery time;Adverse events;

Countries

China

Contacts

Public ContactZhao Xianya

Anhui Public Health Clinical Center, the First Affiliated Hospital of Anhui medical University North District

drxianyazhao@163.com+86 136 3709 6092

Outcome results

None listed

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