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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080589
Enrollment
Unknown
Registered
2024-02-01
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

arthroscopic rotator cuff repair

Interventions

group S1:the high-dose esketamine group (group S1) received 0.5 mg/kg esketamine diluted with normal saline to 10 mL by intravenous injection over 1 minute before surgical incision, followed by at a r
group S2:the low-dose esketamine group (group S2) received 0.25 mg/kg esketamine diluted with normal saline to 10 mL by intravenous injection over 1 minute before surgical incision, followed by at a r
group C:the control group (group C) received equal volume of normal saline.

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) age = 18 years old; (2) ASA physical status I–III; (3) BMI 18-30; (4)planning elective general anesthesia for Arthroscopic shoulder surgery; and (5) voluntary signed informed consent by the patient or their legal guardian.

Exclusion criteria

Exclusion criteria: (1) An established mental illness; (2) Patients with preoperative cognitive or language impairments that hindered communication;(3) Patients with a history of chronic pain or opioid abuse before 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 =360ml of 5% beer or 45ml of 40% liquor or 150 ml of wine); (5) postoperative admission to the ICU;(6)allergy to the active ingredient or excipient of S-ketamine 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 than180mmHgor resting diastolic blood pressure greater than100 mmHg) , untreated/undertreated hyperthyroidism ; (8) Male or Female with family planning;(9) involvement in other drugs or medical devices of clinical research for a duration of approximately three months.

Design outcomes

Primary

MeasureTime frame
the quality of recovery scores based on the QoR-15 scale on POD1;

Secondary

MeasureTime frame
the quality of recovery scores based on the QoR-15 scale on POD3;cerebral desaturation events(CDEs);the consumption of remifentanil;rescue analgesia after surgery;NRS pain scores on POD1 and POD2;The quantity of vasoactive medications administered during the procedure;Postoperative delirium developed at 24, 48, and 72 hours after surgery(3D-CAM scale);

Countries

China

Contacts

Public ContactQirong Sun/Leng Zhou

West China Hospital, Sichuan University

sunqirong0504@163.com+86 187 1579 6395

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026