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Study on the safety and effectiveness of esketamine and alfentanil combined with propofol in painless colorectal endoscopy

Study on the safety and effectiveness of esketamine and alfentanil combined with propofol in painless colorectal endoscopy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062605
Enrollment
Unknown
Registered
2022-08-14
Start date
2022-08-15
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

digestive tract disease

Interventions

control group:Sufentanil in combination with propofol
experimental group 1:Esketamine in combination with propofol
experimental group 2:Afentanil in combination with propofol

Sponsors

The Central Hospital of Enshi Tujia and Miao Autonomous Prefesture
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 - 65 years; 2. Patients undergoing elective painless gastrointestinal ensoscopy; 3. ASA I-II grade; 4. No serious cardiovascular and cerebrovascular diseases, normal liver and kidney functions, and no other special medical history of anesthesia drug allergy. Patients with any of the following exclusion criteria were not eligible for this study; 5. Patients or their families have a full understanding of the purpose and significance of this trial, voluntarily participate in this clinical trial, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. It is difficult to evaluate the efficacy of the patient's physical condition (such as patients with craniocerebral injury, possible intracranial hypertension, cerebral aneurysm, history of cerebrovascular accident, and history of central nervous system diseases); 2. Diabetic patients whose blood sugar has not been satisfactorily controlled (fasting blood sugar >= 11.1mmol/L during the screening period); 3. History of myocardial infarction and unstable angina pectoris within 6 months before the screening period; 4. Patients with bradycardia (heart rate = 160 mmHg during the screening period, and/or diastolic blood pressure >= 100 mmHg during the screening period, and systolic blood pressure 1.5 times the upper limit of normal value, APTT > 1.5 times the upper limit of normal value), with bleeding tendency (such as active peptic ulcer) or receiving thrombolytic or anticoagulation therapy; 8. Abnormal liver function, ALT and/or AST > 1.5 times the upper limit of normal; 9. Abnormal renal function, serum creatinine (Cr) and/or blood urea nitrogen (BUN) > 1.5 times the upper limit of normal; dialysis patients; 10. Allergic to the components or components of the test drug; 11. Women who are pregnant or breastfeeding; 12. Participate in clinical trials of other drugs within 3 months; 13. Patients with a history of hyperthyroidism; 14. Patients with a history of elevated intraocular pressure (such as glaucoma) or puncture eye injury; 15. Patients with a history of asthma; 16. Patients who are judged to have difficulty in airway management (modified Markov score grade IV).

Design outcomes

Primary

MeasureTime frame
respiratory depression;hypotension;Modified Observer's Assessment Alert/ Sedation, MOAA/S;Intubation tolerance score;Onset time of anesthesia;Anesthesia recovery time;Hospital Discharge score;nausea;Vomit;Postoperative restlessness;polycardia;bradycardia;hypertension;Postoperative psychiatric adverse reactions;

Countries

China

Contacts

Public ContactZhu Xianlin

The Central Hospital of Enshi Tujia and Miao Autonomous Prefesture

343205560@qq.com+86 15027224426

Outcome results

None listed

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