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Effect of esketamine on postoperative quality of recovery in patients undergoing arthroscopic rotator cuff repair: protocol for a prospective, randomized, double-blind study

Effect of Intraoperative Continuous Infusion of Esketamine on Early Postoperative Quality of Life in Patients With Arthroscopic Rotator Cuff Repair: A Single-center, Prospective, Randomized Controlled Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102085
Enrollment
Unknown
Registered
2025-05-08
Start date
2024-01-16
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

Group C:An equal dose of saline solution
S1 group:Esketamine 0.5mg/kg was administered before induction and esketamine 0.25mg/kg/h intraoperatively was continuously pumped intravenously to sutures.
S2 group:Esketamine 0.25mg/kg was administered before induction and esketamine 0.125mg/kg/h intraoperatively was continuously pumped intravenously to sutures.

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged>=18  years; 2.American Society of Anesthesiologists (ASA) physical status I–II; 3.BMI 18-30; 4. Arthroscopic rotator cuff repair surgery under general anesthesia is planned to be elective; 5. Have the ability to read and write, and can sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.An established mental illness; 2.Severe disorders affecting consciousness or mental health, such as schizophrenia, mania, bipolar disorder, psychosis, and cognitive dysfunction; 3.A history of chronic pain or opioid abuse prior to surgery; 4.drug and/or alcohol abuse within the last 3 months, defined as consuming an average of more than 2 units of alcohol per day (1 unit =360 ml of 5% beer or 45 ml of 40% liquor or 150 ml of wine); 5.Postoperative admission to the ICU; 6.Allergy to the active ingredient or excipient of esketamine hydrochloride injection; 7.Contraindications for esketamine use including a risk for serious rise in blood pressure or intracranial pressure, high intraocular pressure (glaucoma), poorly controlled hypertension (resting systolic blood pressure greater than180 mmHg or resting diastolic blood pressure greater than 100 mmHg),and untreated/undertreated hyperthyroidism; 8.Male or female with family planning concerns; 9.Involvement in other drugs or medical devices clinical research for a duration of approximately3 months.

Design outcomes

Secondary

MeasureTime frame
3D-CAM;NRS-R scores within 48h post-op and total rescue med dosage;Averse event;The quality of recovery on the third postoperative day;Intraoperative cerebral desaturation incidence rate;

Primary

MeasureTime frame
Postoperative recovery quality on the first day;

Countries

China

Contacts

Public ContactLeng Zhou

West China Hospital of Sichuan University

zhoulenghx@foxmail.com+86 18980601585

Outcome results

None listed

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