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Effect of dexmedetomidine combined with melatonin on postoperative sleep disturbance in patients undergoing laparoscopic hysterectomy

Effect of dexmedetomidine combined with melatonin on postoperative sleep disturbance in patients undergoing laparoscopic hysterectomy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026205
Enrollment
Unknown
Registered
2019-09-26
Start date
2019-10-01
Completion date
Unknown
Last updated
2019-09-30

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

Conditions

postoperative sleep disorder

Interventions

Control group:placebo
Dexmedetomidine group:Dexmedetomidine
dexmedetomidine combined with melatonin group:dexmedetomidine combined with melatonin

Sponsors

Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ASA grade I ~ II, aged 18 ~ 65 years, patients who were selected for laparoscopic total hysterectomy and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Previous central nervous system diseases and mental diseases. 2. Previous serious heart, liver and kidney diseases. 3. People who are allergic to dexmedetomidine and melatonin. 4. Take other sedatives and antidepressants before surgery. 5. Drug and alcohol dependence. 6. Preoperative PSQI>7 points.

Design outcomes

Primary

MeasureTime frame
Pittsburgh sleep quality index;

Secondary

MeasureTime frame
Athens Insomnia Scale ;Salivary cortisol;Plasma interleukin-6, interleukin-10, tumor necrosis factor concentration ;

Countries

China

Contacts

Public ContactZhang Yueying

Xuzhou Medical Univetsity

zyy0218@126.com+86 13815310789

Outcome results

None listed

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