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Effect of continuous infusion of esmketamine during operation on pain and long-term quality of life after arthroscopic rotator cuff repair: a randomized controlled study

Effect of continuous infusion of esmketamine during operation on pain and long-term quality of life after arthroscopic rotator cuff repair: a randomized controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101950
Enrollment
Unknown
Registered
2025-05-06
Start date
2025-04-07
Completion date
Unknown
Last updated
2025-05-12

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

Conditions

Rotator cuff injury

Interventions

Test Group 1:In the S1 group, 0.5 mg/kg esketamine was intravenously administered in 5 ml dilution before skin incision. During surgery, continuous infusion at 0.25 mg/kg/h was maintained until skin c
Control group (Group C):In Group C, a 5ml normal saline IV injection was given before skin incision. Continuous IV infusion at the esketamine group's dosage was maintained until skin closure.
Test Group 2:In the S2 group, 0.25 mg/kg esketamine was intravenously administered in 5 ml dilution before skin incision. During surgery, continuous infusion at 0.125 mg/kg/h was maintained until skin

Sponsors

West China Hospital, Sichuan university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1: 18-65 years old, regardless of gender 2: ASA I-II grade 3: 18.5 kg/m^2<= BMI <28kg/m^2 4: Arthroscopic rotator cuff repair under general anesthesia 5: Individuals who volunteer to participate in this study must possess proficient reading and writing skills and be capable of signing the informed consent form

Exclusion criteria

Exclusion criteria: 1: Patient with severe heart, brain, liver and kidney diseases; 2: Patient with long-term history of taking psychotropic drugs and diagnosed mental illness; 3: Inability to communicate before surgery due to cognitive impairment or language impairment; 4: Long-term use of psychiatric medications and diagnosed mental disorders. 5: Drug or alcohol abuse in the past 3 months, averaging >2 units daily (1 unit = 360ml 5% beer, 45ml 40% liquor, or 150ml wine); 6: It is planned to enter ICU after operation; 7: Known allergic to esketamine; 8: Patient contraindicated for esketamine injection: intracranial aneurysm, elevated blood/intracranial pressure risk, high intraocular pressure/glaucoma/penetrating eye injury, uncontrolled hypertension (resting BP >180/110 mmHg), or untreated hyperthyroidism; 9: Men and women planning to have children; 10: Participation in other clinical trials within the past three months; 11: Researchers found more reasons to exclude participants from this study.

Design outcomes

Primary

MeasureTime frame
The incidence of NRS-R score >= 4 within 48 hours;

Secondary

MeasureTime frame
delirium;;Ramsay;adverse event;Total rescue medication given within 48 hours post-surgery;Patient and family satisfaction with postoperative pain management;

Countries

China

Contacts

Public ContactLeng Zhou

Department of Anesthesiology, West China Hospital, Sichuan university

zhoulenghx@foxmail.com+86 189 8060 1585

Outcome results

None listed

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