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Effect of Intraoperative Intravenous Infusion of Dexmedetomidine on Postoperative Sleep Quality in Perimenopausal Women Undergoing Laparoscopic Surgery

Effect of Intraoperative Intravenous Infusion of Dexmedetomidine on Postoperative Sleep Quality in Perimenopausal Women Undergoing Laparoscopic Surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114562
Enrollment
Unknown
Registered
2025-12-15
Start date
2025-12-15
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Postoperative Sleep Disorders

Interventions

Study Group:Study Group: Intravenous infusion of dexmedetomidine at a rate of 0.2-0.4 µg/kg·h starting from 5 minutes after tracheal intubation under anesthesia induction until 30 minutes before the e
Control Group:Control Group: Infusion of normal saline injection at the same volume and rate at the same time points.

Sponsors

The First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Perimenopausal patients undergoing elective laparoscopic surgery under general anesthesia at The First Affiliated Hospital of Dalian Medical University from October 2025 to October 2026. 2. American Society of Anesthesiologists (ASA) physical status classification: Grade ?-?. 3. Age: 45-55 years old. 4. Patients who meet the criteria for entering perimenopause as judged by gynecologists: changes in menstrual cycle length, with a variation of adjacent cycle length >= 7 days, recurring within 10 menstrual cycles. 5. Voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Preoperative Pittsburgh Sleep Quality Index (PSQI) score >7. 2. Hypersensitivity to dexmedetomidine. 3. History of neurological or psychiatric diseases. 4. Long-term drug dependence, with smoking history (>10 cigarettes/day) and alcohol abuse history (alcohol intake >40g/day). 5. Preoperative liver or kidney dysfunction (ALT/AST >2 times the upper limit, eGFR 5 consecutive minutes). 10. Patients who refuse to participate in this study. Enrolled cases that meet any of the following criteria should be excluded: (1) Do not meet the inclusion criteria or meet the exclusion criteria; (2) Forced termination of the trial during surgery; (3) Failure to manage according to the specified protocol; (4) Loss to follow-up.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index (PSQI) scores ;

Secondary

MeasureTime frame
Sleep quality detected by Fitbit Charge 4 ; Visual Analog Scale (VAS) scores;Hamilton Anxiety Scale (HAMA) scores; analgesic use;Adverse Events;

Countries

China

Contacts

Public ContactLü Meihong

The First Affiliated Hospital of Dalian Medical University

105834061@qq.com+86 180 9887 6206

Outcome results

None listed

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