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Effect of low-dose esketamine on postoperative depression in patients undergoing single-port laparoscopic hysterectomy: a prospective, randomized controlled study

Effect of low-dose esketamine on postoperative depression in patients undergoing single-port laparoscopic hysterectomy: a prospective, randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103453
Enrollment
Unknown
Registered
2025-05-29
Start date
2024-05-02
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Uterine fibroids

Interventions

Esketamine Group (E):Esketamine 0.3 mg/kg intravenous bolus was administered, followed by continuous intravenous injection of esketamine at a dose of 1.2 mg/kg/hour with a micropump until the skin was
This is followed by an intravenous self-controlled analgesic pump equipped with esketamine
Saline group (S group):Intravenous bolus injection of the same volume of normal saline as in the intervention group, followed by continuous intravenous pumping of normal saline at the same rate as the
This is followed by an ordinary intravenous self-controlled analgesic pump

Sponsors

Xinxiang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 35-65 years old; 2. Body weight refers to 18-28kg/m^2; 3. ASAI. or Class II; 4. Patients diagnosed with uterine fibroids who underwent elective single-port laparoscopic total hysterectomy.

Exclusion criteria

Exclusion criteria: 1. Refusal to participate in clinical observation; 2. History of psychiatric illness; 3. Patients with a history of cerebrovascular accident, increased intracranial pressure, intracranial space-occupying lesions, glaucoma, hyperthyroidism and other contraindications to esketamine; 4. Those with a history of epilepsy or manic seizures; 5. Those with a history of malignant tumors; 6. History of gynecological surgery; 7. Those who cannot use WeChat to complete the questionnaire independently.

Design outcomes

Primary

MeasureTime frame
HADS depression score 6 months after surgery;

Secondary

MeasureTime frame
Preoperative, 48h, 72h, 1 month, 3 months HADS score and 6 months HADS anxiety score;Resting state and active NRS pain scores at 24, 48, and 72 h postoperatively;Intraoperative use of anesthetic and analgesic drugs;On the third day after surgery, the patient's satisfaction score with the analgesic effect in the hospital was evaluated (using VAS score, 0= very dissatisfied, 1-3= dissatisfied, 4-6= neutral, 7-9= satisfied, 10= very satisfied).;Incidence of postoperative adverse reactions to opioids, such as nausea, vomiting, and pruritus;Postoperative gastrointestinal function recovery time: first anal exhaust time (h), defecation time (h);

Countries

China

Contacts

Public ContactShao Kun

Xinxiang Central Hospital

shaokunxxmu@126.com+86 137 8197 8391

Outcome results

None listed

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