An interventional study of esketamine in Patients Undergoing General Anesthesia Laparoscopic Uterine Surgery, sponsored by Zhuan Zhang. Completed at 1 site in China. Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Zhuan Zhang · Not applicable, Interventional, and Other
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.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's enrollment of 138 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Zhuan Zhang is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
(7)hearing or visual impairment that precludes a scale assessment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: esketamine
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.
Changes in the level of actigraphy
Through the actigraphy, monitor the patient's sleep quality.
Time frame: 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.
Time frame: Baseline (the night before surgery), postoperative nights 1, 2 and 3
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Postoperative days 1 and 2
Recovery of gastrointestinal function
Record the time of the first postoperative exhausting
Time frame: Postoperative first 1 day
Recovery of gastrointestinal function
Record the time of the first postoperative bowel movement
Time frame: Postoperative first 1 day
Recovery of gastrointestinal function
Record the time of the first postoperative feeding
Time frame: Postoperative first 1 day
Postoperative adverse reactions
Record the occurrence of adverse reactions (nausea and vomiting, nightmares, dizziness, and mirages) on the 1st postoperative day.
Time frame: Postoperative day 1
Ran from Mar 2023 to primary completion in Nov 2023, 8 months.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's 8 months is below that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Esketamine
Sleep Initiation and Maintenance Disorders →
Zhuan Zhang