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Clinical study on the anesthetic effect of different doses of propofol combined with oxycodone in the peri-endoscopic period for painless gastroscopy in elderly patients

Clinical study on the anesthetic effect of different doses of propofol combined with oxycodone in the peri-endoscopic period for painless gastroscopy in elderly patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109036
Enrollment
Unknown
Registered
2025-09-10
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Gastrointestinal polyps, etc.

Interventions

The 0.3 mg/kg cefoperazone + oxycodone group (Group C1):0.3 mg/kg cefoperazone + oxycodone
the 0.25 mg/kg cefoperazone + oxycodone group (Group C2):0.25 mg/kg cefoperazone + oxycodone
the 0.2 mg/kg cefoperazone + oxycodone group (Group C3):0.2 mg/kg cefoperazone + oxycodone

Sponsors

Xuanwu Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients undergoing painless gastroscopy are aged 65 years or older, with no gender restrictions; 2. Both patients and their families have given informed consent; 3. American Society of Anesthesiologists (ASA) classification is grade I-III; 4. Patients without a history of long-term use of sedatives, analgesics, and antidepressants; 5. Conscious, able to communicate, without cognitive impairment or concurrent severe mental and neurological disorders.

Exclusion criteria

Exclusion criteria: 1. Including severe cardiovascular diseases, such as unstable angina pectoris, acute myocardial infarction, heart failure or arrhythmia within one month; 2. Have severe respiratory diseases, such as chronic bronchitis, asthma, COPD, emphysema, etc., or have had upper respiratory tract infection within one month prior to the surgery; 3. Complicated with severe cerebrovascular diseases, such as cerebral infarction, cerebral hemorrhage, severe stenosis of cerebral vessels, and intracranial aneurysms; 4. Abnormal liver and kidney functions, with AST and/or ALT >= 2.5×ULN, TBIL >= 1.5×ULN, urea or urea nitrogen >= 1.5×ULN, and serum creatinine higher than the upper limit of normal range; 5. Merge patients with severe mental disorders such as epilepsy and depression; 6. Patients with a history of long-term use of sedative, analgesic and antidepressant drugs; 7. Patients with preoperative cognitive impairment who are unable to communicate and cooperate with the diagnosis and treatment; 8. Patients with a history of allergies to anesthetics such as propofol and oxycodone; 9. Patients who are judged to have difficulty in managing their respiratory system, such as those with a modified Mallory score of level IV, or those with obstructive sleep apnea syndrome, or those with a body mass index (BMI) of >= 30 kg/m^2; 10. Hypertensive patients whose blood pressure has not been satisfactorily controlled (systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg during the screening period).

Design outcomes

Primary

MeasureTime frame
The incidence of respiratory depression in each of the three groups of patients during the peri-general anesthesia gastroscopy period;;

Secondary

MeasureTime frame
SPO2, SBP, DBP, MAP, HR, RR and their change rates before and after endoscopy.;Other indicators: Occurrence of adverse reactions such as injection pain, coughing, body movement, hypertension and hypotension during the period of general anesthesia and intubation.;Compare the induction times, The time for a gastroscopy,endoscopy examination times, recovery times, and PACU stay times for each group.;Patient satisfaction after diagnosis and treatment;Usage of vasoactive drugs during endoscopic examination period;Total additional amount and frequency of ciprofol during induction of general anesthesia;

Countries

China

Contacts

Public ContactMinhui Kan

Xuanwu Hospital Capital Medical University

kmh2004@126.com+86 10 8319 9341

Outcome results

None listed

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