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Effect of intraoperative esketamine infusion on sleep quality after gynecologic laparoscopy and correlation analysis with characteristic EEG and EEG spectrum

Effect of intraoperative esketamine infusion on sleep quality after gynecologic laparoscopy and correlation analysis with characteristic EEG and EEG spectrum

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084271
Enrollment
Unknown
Registered
2024-05-14
Start date
2024-05-31
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Sleep-wake disorder

Interventions

Esketamine group:After induction of anesthesia, esketamine 1mg/ (kg·h) (concentration 1mg/ml) was administered intravenously for 30min.
Control group :After induction of anesthesia, the same volume of 0.9% normal saline was injected intravenously for 30 min.

Sponsors

Women's Hospital School of Medicine Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age 18-65 years old; ASA I-II level; Patients undergoing gynecological laparoscopic surgery; The operation lasts longer than 1 hour.

Exclusion criteria

Exclusion criteria: Patients refused to participate in the study; Body mass index (BMI) greater than 30; There is a clear history of mental sleep problems in the past (depression, schizophrenia, sleep disorders, PSQI > 7 score 18) or a family history of sleep problems in three generations of the second line; Cognitive or communication impairment; A recent history of substance abuse; Contraindications or esketamine allergy; Cognitive impairment or inability to communicate; This study must be approved by the Ethics Committee of the hospital, and all patients participating in the study must sign the informed consent of anesthesia and experiment.

Design outcomes

Primary

MeasureTime frame
Incidence of sleep disturbance on the first day after surgery;

Secondary

MeasureTime frame
Eeg spectral values;Electroencephalogram Index;Incidence of sleep disturbance;Numeric rating scale of sleep;Pittsburgh Sleep Quality Index score;Insomnia Severity Index score;Self-Rating Anxiety Scale score;

Countries

China

Contacts

Public ContactLili Xu

Women's Hospital School of Medicine Zhejiang University

xulili@zju.edu.cn+86 182 6814 4502

Outcome results

None listed

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