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Mini-dose esketamine-dexmedetomidine combination to supplement analgesia on sleep quality and emotional state in patients after gynecological laparoscopy: a double-blind randomised trial

Mini-dose esketamine-dexmedetomidine combination to supplement analgesia on sleep quality and emotional state in patients after gynecological laparoscopy: a double-blind randomised trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124370
Enrollment
Unknown
Registered
2026-05-11
Start date
2025-09-05
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

Gynecologic tumor

Interventions

Control group:The control group used a patient-controlled intravenous analgesia protocol of sufentanil at 2 µg/kg diluted in 200 ml of normal saline.
Esketamine - dexmedetomidine group: In the mini-dose esketamine- dexmedetomidine group, the protocol for patient-controlled intravenous analgesia was esketamine 50 mg, dexmedetomidine 200 mg, sufentan

Sponsors

Nantong First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age from 18 to 60 years. 2. ASA ? ~ ?. 3. Gynecological endoscopic surgery performed at an appropriate time. 4. Require patient controlled intravenous analgesia after surgery.

Exclusion criteria

Exclusion criteria: 1. Preoperative Severe sinus bradycardia (heart rate = III. 2. OSAS. 3. BMI > 30. 4. History of hyperthyroidism or pheochromocytoma, schizophrenia, epilepsy, or myasthenia gravis. 5. Severe liver and kidney dysfunction. 6. Preoperative PSQI > 7. 7. A recent history of substance abuse. 8. Contraindicated or allergic to esketamine or dexmedetomidine. 9. Cognitive dysfunction or inability to communicate.

Design outcomes

Primary

MeasureTime frame
Sleep Quality Numerical Rating Scale (NRS);Athena Insomnia Scale (AIS);Hospital Anxiety and Depression Scale (HADS);

Secondary

MeasureTime frame
Visual Analogue Scale (VAS);The cumulative consumption of sufentanil in the analgesic pump within 48 hours postoperatively;

Countries

China

Contacts

Public ContactCai Mengmeng

Nantong First People's Hospital

mengmengcai880924@163.com+86 138 0629 0565

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026