Effects of different doses of esmketamine on sleep quality after gynecologic laparoscopic tumor surgery: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500102453

Enrollment

Unknown

Registered

2025-05-15

Start date

2025-05-15

Completion date

Unknown

Last updated

2025-05-19

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

Conditions

sleep disorder

Interventions

Group A:0.3mg/kg/h esketamine

Group B:0.2mg/kg/h esketamine

Eligibility

Sex/Gender

Female

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Proposed laparoscopic gynecological tumor surgery; 2. ASA classification I-II; 3. Age 18-65 years; 4. BMI < 30; 5. Pittsburgh Sleep Quality Index (PSQI) < 5 points; 6. Sign the anesthesia informed consent and clinical research informed consent.

Exclusion criteria

Exclusion criteria: 1.poorly controlled or untreated hypertension, hyperthyroidism, coronary heart disease, acute and chronic heart failure, liver and kidney failure; 2.increased intracranial pressure or central nervous system injury; 3.patients with mental disorders or unable to cooperate with the scale assessment; 4.esketamine or ketamine allergy; 5.decompensated shock; 6.excluded sleep apnea syndrome; 7.Hamilton Depression Scale (HAMD) score > 8 points, State Anxiety Inventory (SAI) score > 50 points, Trait anxiety scale (TAI) score > 50 points.

Design outcomes

Primary

Measure	Time frame
Sleep efficiency on the first postoperative day;	—

Secondary

Measure	Time frame
Postoperative ambulation time, catheter removal time, exhaust time, hospital stay time;The difference of inflammatory index (postoperative - preoperative) DSII, DPLR, DNLR;The data of sleep monitoring bracelet included sleep score, time to fall asleep, awakening time, total sleep duration, number of awakenings, and proportion of deep sleep;The time of the modified Aldrete score > 9, the recovery time, the extubation time and the adverse reactions during the recovery period;Hemodynamic parameters before and after induction and the number of intraoperative adverse events were recorded;The intraoperative dose of remifentanil was used;NRS pain score and rescue analgesic use after surgery;SMHSQ score, including sleep latency, subjective sleep depth, arousal frequency, sleep quality, wakefulness after awakening, sleep satisfaction, difficulty in falling asleep after awakening, difficult;	—

Measure

Time frame

Postoperative ambulation time, catheter removal time, exhaust time, hospital stay time;The difference of inflammatory index (postoperative - preoperative) DSII, DPLR, DNLR;The data of sleep monitoring bracelet included sleep score, time to fall asleep, awakening time, total sleep duration, number of awakenings, and proportion of deep sleep;The time of the modified Aldrete score > 9, the recovery time, the extubation time and the adverse reactions during the recovery period;Hemodynamic parameters before and after induction and the number of intraoperative adverse events were recorded;The intraoperative dose of remifentanil was used;NRS pain score and rescue analgesic use after surgery;SMHSQ score, including sleep latency, subjective sleep depth, arousal frequency, sleep quality, wakefulness after awakening, sleep satisfaction, difficulty in falling asleep after awakening, difficult;

—

Countries

China

Contacts

Public ContactXianbao Liu

The Third Affiliated Hospital of Guangzhou Medical University

457163589@qq.com+86 20 81292351

Outcome results

None listed

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