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

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.

Study Overview

• Status: Completed
• Conditions: Patients Undergoing General Anesthesia Laparoscopic Uterine Surgery
• Intervention / Treatment: Drug: esketamine

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China
      • The Affiliated Hospital of Yangzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patient refusal;
2. Known allergy to anesthetic drugs;
3. Preoperative sleep disorder (Pittsburgh Sleep Quality Index [PSQI] > 7);
4. 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;
5. Long-term use of opioids or sedative-hypnotic drugs;
6. History of psychiatric or neurological disease;
7. Previous or planned neurosurgery.

(7)hearing or visual impairment that precludes a scale assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Esketamine for induction 0.15mg/kg and maintenance 0.15mg/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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery of gastrointestinal function	Record the time of the first postoperative exhausting	Postoperative first 1 day
Recovery of gastrointestinal function	Record the time of the first postoperative bowel movement	Postoperative first 1 day
Recovery of gastrointestinal function	Record the time of the first postoperative feeding	Postoperative first 1 day
Changes in the level of Mean Arterial Pressure	The outcome above should be measured at the time 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.	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	The above results should be measured preoperatively, upon surgery completion, and on the 1st postoperative day.	Preoperatively, upon surgery completion, postoperative day 1
Changes in the level of Melatonin	The above results should be measured preoperatively, upon surgery completion, and on the 1st postoperative day.	Preoperatively, upon surgery completion, postoperative day 1
Changes in the level of BDNF	The above results should be measured preoperatively, upon surgery completion, and on the 1st postoperative day.	Preoperatively, upon surgery completion, postoperative day 1
Changes in the level of IL-10	The above results should be measured preoperatively, upon surgery completion, and on the 1st postoperative day.	Preoperatively, upon surgery completion, postoperative day 1
Changes in the level of Heart Rate	The outcome above should be measured at the time 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.	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 Oxygen saturation	The outcome above should be measured at the time 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.	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 the visual analogue scale	Assess the patient's pain by asking on a scale of 0-10, with higher scores representing more severe pain.	Postoperative days 1 and 2
Postoperative adverse reactions	Record the occurrence of adverse reactions (nausea and vomiting, nightmares, dizziness, and mirages) on the 1st postoperative day.	Postoperative day 1

Collaborators and Investigators

• Sponsor: Zhuan Zhang
• Investigators: Principal Investigator: zhuan zhang, professor, The Affiliated Hospital of Yangzhou University

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: December 17, 2022
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Sleep quality; Esketamine; General anesthesia laparoscopic uterine surgery; Recovery of gastrointestinal function
• Additional Relevant MeSH Terms: Psychotropic Drugs; Antidepressive Agents; Esketamine
• Other Study ID Numbers: 20221217

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No