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

Sponsor
Zhuan Zhang (Other)
Overall Status
Recruiting
CT.gov ID
NCT05715671
Collaborator
(none)
60
1
3
7.9
7.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
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
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Esketamine for induction 0.2mg/kg and maintenance 0.2mg/kg/h

Drug: esketamine
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.

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

Drug: esketamine
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.

No Intervention: No esketamine

Outcome Measures

Primary Outcome Measures

  1. Changes in the level of actigraphy [The 1st night before the operation and the 1st and 2nd nights postoperatively]

    Through the actigraphy, monitor the patient's sleep quality

  2. Changes in the level of Pittsburgh sleep quality index [The day before surgery and 1,2,3,7 days]

    Assess the patient's sleep quality by asking questions on the scale

Secondary Outcome Measures

  1. Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure) [Baseline (Before induction), immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation]

    The outcome above should be measured at the time Before induction, immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

  2. Changes in the level of IL-6 [Preoperative, 6 hours postoperative, 24 hours postoperative]

    The above results should be measured preoperatively, 6 hours postoperatively, and 24 hours postoperatively.

  3. Changes in the level of Melatonin [Preoperative, 6 hours postoperative, 24 hours postoperative]

    The above results should be measured preoperatively, 6 hours postoperatively, and 24 hours postoperatively.

  4. Changes in the level of CRP [Preoperative, 6 hours postoperative, 24 hours postoperative]

    The above results should be measured preoperatively, 6 hours postoperatively, and 24 hours postoperatively.

  5. Changes in the level of TNF [Preoperative, 6 hours postoperative, 24 hours postoperative]

    The above results should be measured preoperatively, 6 hours postoperatively, and 24 hours postoperatively.

  6. Changes in the level of Heart Rate [Baseline (Before induction), immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation]

    The outcome above should be measured at the time Before induction, immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

  7. Changes in the level of Oxygen saturation [Baseline (Before induction), immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation]

    The outcome above should be measured at the time Before induction, immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

  8. Changes in the level of the visual analogue scale [6 hours, 12 hours, 24 hours, 48 hours after surgery]

    Assess the patient's pain by asking

  9. Recovery of gastrointestinal function [Postoperative first 1 day]

    Record the time of the first postoperative exhausting

  10. Recovery of gastrointestinal function [Postoperative first 1 day]

    Record the time of the first postoperative bowel movement

  11. Recovery of gastrointestinal function [Postoperative first 1 day]

    Record the time of the first postoperative feeding

  12. Postoperative adverse reactions [The first, second and third day after surgery]

    Record the occurrence of adverse reactions (nausea, vomiting, hallucinations, abdominal distension) on the first, second and third postoperative days

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Age ≥ 40 years;

  2. ASA class I-III;

  3. Proposed laparoscopic total hysterectomy/myomectomy;

  4. Operative time ≥ 1 h.

Exclusion Criteria:
  • patient refusal;
  1. known allergy to anesthetic drugs;

  2. chronic use of opioids or sedative-hypnotic drugs;

  3. history of psychiatric or neurological disease;

  4. previous or planned neurosurgical procedures;

  5. hearing or visual impairment that precludes a scale assessment.

Contacts and Locations

Locations

Site City State Country Postal Code
1 the Affiliated Hospital of Yangzhou University Yangzhou Jiangsu China

Sponsors and Collaborators

  • Zhuan Zhang

Investigators

  • Principal Investigator: zhuan zhang, professor, The Affiliated Hospital of Yangzhou University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhuan Zhang, Clinical Professor, Yangzhou University
ClinicalTrials.gov Identifier:
NCT05715671
Other Study ID Numbers:
  • 20221217
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhuan Zhang, Clinical Professor, Yangzhou University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023