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Effects of Esketamine on Perioperative Anxiety and Depression: A Multicenter Randomized Controlled Study.

Effects of Esketamine on Perioperative Anxiety and Depression: A Multicenter Randomized Controlled Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094555
Enrollment
Unknown
Registered
2024-12-24
Start date
2025-01-03
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Perioperative anxiety and depression

Interventions

Experimental group:A single infusion of esketamine at a dose of 0.4 mg/kg.
Control group:0.9% 20 ml normal saline

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 40-65 years old; 2. ASA grading I-III; 3. Patients undergoing elective non-cardiac surgery under general anesthesia; 4. Four groups of people (Nervousness, Sleep disturbance and irritability, Nervousness, Sleep disturbance, and excessive worry, and Highly combined symptoms) that fit the prediction model; 5. Patients who have signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with relative contraindications to ketamine or esketamine, such as severe hypertension, coronary heart disease, cardiac insufficiency, pulmonary hypertension, cranioocular hypertension, and hyperthyroidism; 2. Patients who have received treatment for depression within 2 months; 3. Patients with severe liver and kidney insufficiency; 4. Opioid abusers and alcoholics; 5. Patients with a history of allergic reaction to the drugs used in this study; 6. Patients with communication difficulties and unable to cooperate with filling in the questionnaire; 7. Patients who participated in other interventional studies within 3 months.

Design outcomes

Primary

MeasureTime frame
Postoperative length of hospital stay (with the day of surgery defined as day 0);The incidence of complications within 30 days after surgery.;Postoperative satisfaction (scored on a scale of 0 to 10).;

Secondary

MeasureTime frame
Postoperative recovery will be assessed using the QoR-15 scale at 7 and 30 days after surgery.;Postoperative analgesic consumption;The PHQ-9 and GAD-7 scores at 7 and 30 days postoperatively.;Postoperative resting and movement pain scores (NRS) at 7 and 30 days after surgery.;Cognitive function assessment using the AD-8 scale at 7 and 30 days postoperatively.;Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) at 7 and 30 days postoperatively.;Adverse events;

Countries

China

Contacts

Public ContactQian Li

West China Hospital of Sichuan University

hxliqian@foxmail.com+86 18980601635

Outcome results

None listed

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