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Study on postoperative analgesia of ropivacaine hydrochloride combined with esmketamine or alfentanil hydrochloride in patients undergoing knee arthroscopic surgery

Study on postoperative analgesia of ropivacaine hydrochloride combined with esmketamine or alfentanil hydrochloride in patients undergoing knee arthroscopic surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069052
Enrollment
Unknown
Registered
2023-03-06
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

Disease of skeletal motor system

Interventions

Control group experimental group:Ropivacaine intra-articular injection
Affentanyl group:Alfentanyl plus ropivacaine intra-articular injection
Estroketamine group:Estramide plus ropivacaine intra-articular injection

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) 18 years old = age = 65 years old; (2) Patients undergoing knee arthroscopy under elective general anesthesia; (3) ASA grade I ~ II; (4) No serious cardiovascular and cerebrovascular disease, normal liver and kidney function, no anesthetic allergy or other special medical history. Patients with any of the following exclusion criteria cannot be included in 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 the informed consent form.

Exclusion criteria

Exclusion criteria: (1) It is difficult to evaluate the curative effect of the patient's physical condition (such as severe central nervous system surgery or intracranial surgery)(2) Diabetes patients whose blood glucose has not been satisfactorily controlled (fasting blood glucose = 11.1mmol\/l in the screening period); (3) There was a history of myocardial infarction and unstable angina pectoris within 6 months before the screening period; (4) Patients with bradycardia (heart rate = 50 beats / min) and arrhythmia within 6 weeks before the screening period; Third degree atrioventricular block (excluding patients with pacemaker); (5) Patients with systolic blood pressure = 90mmHg or uncontrolled hypertension within 6 weeks before the screening period; (6) Patients with mental system diseases (such as schizophrenia, depression, etc.) and cognitive impairment; Patients with a history of epilepsy; Previous history of abuse of psychotropic drugs and narcotic drugs; (7) Abnormal coagulation function (Pt or PT-INR > 1.5 times the upper limit of normal value, APTT > 1.5 times the upper limit of normal value), bleeding tendency (such as active gastrointestinal ulcer) or being treated with thrombolysis or anticoagulation; (8) Abnormal liver function, ALT and \ / or ast > 1.5 times the upper limit of normal value; (9) Abnormal renal function, serum creatinine (CR) and \ / or urea nitrogen (BUN) > 1.5 times the upper limit of normal value; Dialysis patients; (10) Allergic to the ingredients or components of the tested drug; (11) Pregnant or lactating women; (12) Participate in clinical trials of other drugs within 3 months; (13) Patients with myasthenia gravis, schizophrenia and severe depression;

Design outcomes

Primary

MeasureTime frame
Time of first postoperative analgesia;

Secondary

MeasureTime frame
Nrs-r within 24h (resting);NRS-M within 24h;Rebound pain;heart rate;blood pressure;Blood oxygen saturation;dizzy;hallucination;Drowsiness;nausea;vomit;skin Itch;diplopia;Sedation score;postoperative delirium;

Countries

China

Contacts

Public ContactZhu Xianlin

The central hospital of Enshi tujia and miao autonomous prefesture

343205560@qq.com15027224426

Outcome results

None listed

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