Impact of Intravenous Remimazolam during Surgery on Postoperative Sleep Quality in Gynecologic Laparoscopic Patients: A Correlation Analysis with Characteristic EEG Signatures and Spectral Features

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500100423

Enrollment

Unknown

Registered

2025-04-09

Start date

2025-04-20

Completion date

Unknown

Last updated

2025-06-02

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

Conditions

Patients scheduled for elective gynecological laparoscopic surgery

Interventions

Remazolam group:Remimazolam was administered at a dose of 0.2 mg/kg during anesthesia induction, and then infused continuously at a rate of 1 mg/(kg·h) (concentration 1 mg/ml) for 30 minutes via intra

Control group:Control group: An equal volume of 0.9% normal saline was given during anesthesia induction and surgery.

Eligibility

Sex/Gender

Female

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age 18-65 years; ASA I-II level; Patients undergoing gynecological laparoscopic surgery; Surgery duration greater than 1 hour.

Exclusion criteria

Exclusion criteria: Patients who refuse to participate in the study; Body Mass Index (BMI) above 30; History of clear mental or sleep disorders (depression, schizophrenia, sleep disorders with PSQI > 7, etc.) or family history of sleep problems within two generations; Cognitive impairment or communication disorders; Recent history of drug abuse; Contraindications or remazolam allergy; Cognitive impairment or inability to communicate; Recent use of drugs affecting the central nervous system, including sedatives or psychostimulants. This study must be approved by the hospital ethics committee, and all participating patients must sign an informed consent form for anesthesia and the trial.

Design outcomes

Primary

Measure	Time frame
The incidence of sleep disorders on the first day after surgery;	—

Secondary

Measure	Time frame
Pittsburgh sleep quality index(PSQI)score;NRS of subjective sleep quality score ;Insomnia Severity Index(ISI)score ;Self-Rating Anxiety Scale;he incidence of sleep disorders after surgery;Numerical Rating Scale;Ramsay Sedation Scale;The spectral power of intraoperative beta waves (13-30 Hz);The spectral power of alpha waves (8-13 Hz);The spectral power of theta waves (4-8 Hz);The spectral power of delta waves (1-4 Hz);Alpha-Beta Peak Frequency;Anesthesia Index;Burst Suppression Ratio, BSR ;Electromyography, EMG;	—

Measure

Time frame

Pittsburgh sleep quality index(PSQI)score;NRS of subjective sleep quality score ;Insomnia Severity Index(ISI)score ;Self-Rating Anxiety Scale;he incidence of sleep disorders after surgery;Numerical Rating Scale;Ramsay Sedation Scale;The spectral power of intraoperative beta waves (13-30 Hz);The spectral power of alpha waves (8-13 Hz);The spectral power of theta waves (4-8 Hz);The spectral power of delta waves (1-4 Hz);Alpha-Beta Peak Frequency;Anesthesia Index;Burst Suppression Ratio, BSR ;Electromyography, EMG;

—

Countries

China

Contacts

Public ContactLIli Xu

Women's Hospital, Zhejiang University School of Medicine

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

Outcome results

None listed

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