Effect of Subanesthetic Dose of Esketamine on Sleep Quality and Recovery of Gastrointestinal Function in Patients Undergoing General Anesthesia Laparoscopic Uterine Surgery in the Early Postoperative Period

NCT05715671 | Completed

• 1 other identifier: 20221217
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing gynecological surgery are at high risk of developing postoperative sleep disorders. Intraoperative opioid use is detrimental to the patient's postoperative recovery of gastrointestinal function. Esketamine has sedative, hypnotic, analgesic, inflammatory response suppression, and antidepressant effects. Its hypnotic mechanism may be related to its rapid blockade of NMDA receptors and hyperpolarization-activated cyclic nucleotide-gated cation channels. Also can reduce the application of perioperative opioids, which in turn promotes the recovery of gastrointestinal function in patients after surgery.

Conditions

Patients Undergoing General Anesthesia Laparoscopic Uterine Surgery

Keywords

Esketamine; General anesthesia laparoscopic uterine surgery; Sleep quality; Recovery of gastrointestinal function

Outcome Measures

Primary Outcomes (2)

• Changes in the level of actigraphy

  Through the actigraphy, monitor the patient's sleep quality.

  Baseline (the night before surgery), postoperative nights 1 and 2

• Changes in the level of Pittsburgh sleep quality index

  Assess the patient's sleep quality by asking questions on the scale on a scale of 0-21, with higher scores representing poorer sleep quality.

  Baseline (the night before surgery), postoperative nights 1, 2 and 3

Secondary Outcomes (12)

• Changes in the level of Mean Arterial Pressure

  Baseline (before induction), after loading dose of intervention, at the beginning of surgery, upon surgery completion, immediately after extubation, and 30min after transfer to the post-anesthesia care unit

• Changes in the level of IL-6

  Preoperatively, upon surgery completion, postoperative day 1

• Changes in the level of Melatonin

  Preoperatively, upon surgery completion, postoperative day 1

• Changes in the level of BDNF

  Preoperatively, upon surgery completion, postoperative day 1

• Changes in the level of IL-10

  Preoperatively, upon surgery completion, postoperative day 1

Study Arms (3)

Esketamine for induction 0.15mg/kg and maintenance 0.15mg/kg/h

EXPERIMENTAL

Drug: esketamine

Esketamine for induction 0.3mg/kg and maintenance 0.3mg/kg/h

EXPERIMENTAL

Drug: esketamine

No esketamine

NO INTERVENTION

Interventions

esketamine DRUG

The corresponding esketamine dose for each group was used at the end of anesthesia induction, and esketamine was changed to the corresponding maintenance dose for each group prior to surgical skin incision.

Esketamine for induction 0.15mg/kg and maintenance 0.15mg/kg/h; Esketamine for induction 0.3mg/kg and maintenance 0.3mg/kg/h

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 40 and 65 years;
• ASA class I-III;
• Proposed laparoscopic total hysterectomy/myomectomy;
• Operative time ≥ 1 h;
• Body mass index of 18-30 kg/m2.

You may not qualify if:

• Patient refusal;
• Known allergy to anesthetic drugs;
• Preoperative sleep disorder (Pittsburgh Sleep Quality Index \[PSQI\] \> 7);
• Severe hypertension, coronary artery disease, cardiac insufficiency, pulmonary hypertension, pulmonary heart disease, increased cranial pressure, increased intraocular pressure, seizures, shift work, obstructive sleep apnea syndrome;
• Long-term use of opioids or sedative-hypnotic drugs;
• History of psychiatric or neurological disease;
• Previous or planned neurosurgery.
• (7)hearing or visual impairment that precludes a scale assessment.

Sponsors & Collaborators

• Zhuan Zhang: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Location

Related Publications (1)

• Yuan B, Tian S, Pu X, Yin J, Wang M, Feng S, Lv X, Sun Y, Yao H, Li M, Li S, Zhang Z. Esketamine improves postoperative sleep quality in women undergoing gynecological laparoscopy: A prospective, randomized, double-blind, and controlled trial. Sleep Med. 2025 Dec;136:106852. doi: 10.1016/j.sleep.2025.106852. Epub 2025 Oct 14.

  PMID: 41115350 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• zhuan zhang, professor

  The Affiliated Hospital of Yangzhou University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 17, 2022
• First Posted: February 8, 2023
• Study Start: March 25, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

CN (1)