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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Patients Undergoing General Anesthesia Laparoscopic Uterine Surgery

Intervention / Treatment
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* Drug: esketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 40 years; ASA class I-III; Proposed laparoscopic total hysterectomy/myomectomy; Operative time ≥ 1 h. Exclusion Criteria: patient refusal; known allergy to anesthetic drugs; chronic use of opioids or sedative-hypnotic drugs; history of psychiatric or neurological disease; previous or planned neurosurgical procedures; hearing or visual impairment that precludes a scale assessment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esketamine for induction 0.15mg/kg and maintenance 0.15mg/kg/h<br> | Drug: esketamine<br>* 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.<br>|
| Experimental: Esketamine for induction 0.3mg/kg and maintenance 0.3mg/kg/h<br> | Drug: esketamine<br>* 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.<br>|
| No Intervention: No esketamine<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the level of actigraphy | Through the actigraphy, monitor the patient's sleep quality | The 1st night before the operation and the 1st and 2nd nights postoperatively | 
| Changes in the level of Pittsburgh sleep quality index | Assess the patient's sleep quality by asking questions on the scale | The day before surgery and 1,2,3,7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure) | 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 | 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 | 
| Changes in the level of IL-6 | The above results should be measured preoperatively, 6 hours postoperatively, and 24 hours postoperatively. | Preoperative, 6 hours postoperative, 24 hours postoperative | 
| Changes in the level of Melatonin | The above results should be measured preoperatively, 6 hours postoperatively, and 24 hours postoperatively. | Preoperative, 6 hours postoperative, 24 hours postoperative | 
| Changes in the level of TNF | The above results should be measured preoperatively, 6 hours postoperatively, and 24 hours postoperatively. | Preoperative, 6 hours postoperative, 24 hours postoperative | 
| Changes in the level of Heart Rate | 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 | 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 | 
| Changes in the level of Oxygen saturation | 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 | 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 | 
| Changes in the level of the visual analogue scale | Assess the patient's pain by asking | 6 hours, 12 hours, 24 hours, 48 hours after surgery | 
| 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 | 
| Postoperative adverse reactions | Record the occurrence of adverse reactions (nausea, vomiting, hallucinations, abdominal distension) on the first, second and third postoperative days | The first, second and third day after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esketamine, General anesthesia laparoscopic uterine surgery, Sleep quality, Recovery of gastrointestinal function