Clinical trial NCT05715671: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Undergoing General Anesthesia Laparoscopic Uterine Surgery
Keywords: Esketamine
General anesthesia laparoscopic uterine surgery
Sleep quality
Recovery of gastrointestinal function
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 138
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in the level of actigraphy
timeFrame: Baseline (the night before surgery), postoperative nights 1 and 2
measure: Changes in the level of Pittsburgh sleep quality index
timeFrame: Baseline (the night before surgery), postoperative nights 1, 2 and 3
Secondary outcomes:
measure: Changes in the level of Mean Arterial Pressure
timeFrame: 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
measure: Changes in the level of IL-6
timeFrame: Preoperatively, upon surgery completion, postoperative day 1
measure: Changes in the level of Melatonin
timeFrame: Preoperatively, upon surgery completion, postoperative day 1
measure: Changes in the level of BDNF
timeFrame: Preoperatively, upon surgery completion, postoperative day 1
measure: Changes in the level of IL-10
timeFrame: Preoperatively, upon surgery completion, postoperative day 1
measure: Changes in the level of Heart Rate
timeFrame: 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
measure: Changes in the level of Oxygen saturation
timeFrame: 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
measure: Changes in the level of the visual analogue scale
timeFrame: Postoperative days 1 and 2
measure: Recovery of gastrointestinal function
timeFrame: Postoperative first 1 day
measure: Recovery of gastrointestinal function
timeFrame: Postoperative first 1 day
measure: Recovery of gastrointestinal function
timeFrame: Postoperative first 1 day
measure: Postoperative adverse reactions
timeFrame: Postoperative day 1
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University
state: Jiangsu
Study officials:
affiliation: The Affiliated Hospital of Yangzhou University
name: zhuan zhang, professor
role: PRINCIPAL_INVESTIGATOR
References: