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The effect of dexmedetomidine on perioperative electroencephalogram characteristics and postoperative sleep disturbance in patients undergoing laparoscopic gynecological surgery: a randomized controlled trial

The effect of dexmedetomidine on perioperative electroencephalogram characteristics and postoperative sleep disturbance in patients undergoing laparoscopic gynecological surgery: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129593
Enrollment
Unknown
Registered
2026-08-06
Start date
2026-08-15
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Postoperative sleep disorder

Interventions

Dexmedetomidine Group:Intravenous infusion of dexmedetomidine at 0.5 µg/kg 10 minutes before anesthesia induction
during the maintenance phase of anesthesia, intravenous infusion of dexmedetomidine at 0.3 µg/kg/h (discontinued 30 minutes before the end of surgery).
Normal saline Group:Intravenous infusion of normal saline at an equivalent volume to the dexmedetomidine group 10 minutes before anesthesia induction
during the maintenance phase of anesthesia, intravenous infusion of normal saline at an equivalent volume to the dexmedetomidine group (discontinued 30 minutes before the end of surgery).

Sponsors

Jinling Hospital, Affiliated with Nanjing University Medical School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. ASA physical status I-III; 2.Aged 18 to 65 years; 3.Undergoing elective urological laparoscopic surgery; 4.Fully understand the trial procedures and voluntarily participate, with signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Preoperative sleep disturbance with a Pittsburgh Sleep Quality Index (PSQI) score > 7; 2.Preoperative anxiety or depression with a Hospital Anxiety and Depression Scale (HADS) score > 6; 3.Severe cardiac insufficiency, severe hepatic insufficiency (Child-Pugh class C), or renal failure; 4.Long-term use of opioids, sedatives, antidepressants, or anxiolytics; 5.History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis; 6.Inability to communicate effectively, inability to cooperate with sleep assessment, or refusal to participate in the study; 7.Inability to use a patient-controlled intravenous analgesia (PCIA) pump postoperatively.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative sleep disturbance;

Secondary

MeasureTime frame
Changes in patients' peri?operative electroencephalogram;Visual Analogue Scale Score;Postoperative opioid use;

Countries

China

Contacts

Public ContactShen,Jin-chun

Jinling Hospital, Affiliated with Nanjing University Medical School

yyshen0203@163.com+86 158 9599 0011

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026