Patients Undergoing General Anesthesia Laparoscopic Uterine Surgery
Conditions
Keywords
Esketamine, General anesthesia laparoscopic uterine surgery, Sleep quality, Recovery of gastrointestinal function
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.
Interventions
DRUGesketamine
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.
Sponsors
Zhuan Zhang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the level of actigraphy | Baseline (the night before surgery), postoperative nights 1 and 2 | Through the actigraphy, monitor the patient's sleep quality. |
| Changes in the level of Pittsburgh sleep quality index | Baseline (the night before surgery), postoperative nights 1, 2 and 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the level of Melatonin | Preoperatively, upon surgery completion, postoperative day 1 | The above results should be measured preoperatively, upon surgery completion, and on the 1st postoperative day. |
| Changes in the level of BDNF | Preoperatively, upon surgery completion, postoperative day 1 | The above results should be measured preoperatively, upon surgery completion, and on the 1st postoperative day. |
| Changes in the level of IL-10 | Preoperatively, upon surgery completion, postoperative day 1 | The above results should be measured preoperatively, upon surgery completion, and on the 1st postoperative day. |
| Changes in the level of Heart Rate | 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 | 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. |
| 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 | 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. |
| Changes in the level of the visual analogue scale | Postoperative days 1 and 2 | Assess the patient's pain by asking on a scale of 0-10, with higher scores representing more severe pain. |
| Recovery of gastrointestinal function | Postoperative first 1 day | Record the time of the first postoperative exhausting |
| Postoperative adverse reactions | Postoperative day 1 | Record the occurrence of adverse reactions (nausea and vomiting, nightmares, dizziness, and mirages) on the 1st postoperative day. |
| Changes in the level of Oxygen saturation | 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 | 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. |
| Changes in the level of IL-6 | Preoperatively, upon surgery completion, postoperative day 1 | The above results should be measured preoperatively, upon surgery completion, and on the 1st postoperative day. |
Countries
China
Outcome results
None listed