Patients Undergoing General Anesthesia Laparoscopic Uterine SurgeryNCT05715671
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
A study testing esketamine in people with Patients Undergoing General Anesthesia Laparoscopic Uterine Surgery, run by Zhuan Zhang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Patients Undergoing General Anesthesia Laparoscopic Uterine Surgery
- What is being tested?
- esketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 65 years;
- ASA class I-III;
- Proposed laparoscopic total hysterectomy/myomectomy;
- Operative time ≥ 1 h;
- Body mass index of 18-30 kg/m2.
Who cannot join
- Patient refusal;
- Known allergy to anesthetic drugs;
- Preoperative sleep disorder (Pittsburgh Sleep Quality Index [PSQI] > 7);
- 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;
- Long-term use of opioids or sedative-hypnotic drugs;
- History of psychiatric or neurological disease;
- Previous or planned neurosurgery.
- (7)hearing or visual impairment that precludes a scale assessment.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- esketamine
- Keywords
- Esketamine, General anesthesia laparoscopic uterine surgery, Sleep quality, Recovery of gastrointestinal function
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esketamineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Esketamine for induction 0.15mg/kg and maintenance 0.15mg/kg/h | Experimental | Not described Receives: Drug: esketamine |
| Esketamine for induction 0.3mg/kg and maintenance 0.3mg/kg/h | Experimental | Not described Receives: Drug: esketamine |
| No esketamine | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the level of actigraphy
Through the actigraphy, monitor the patient's sleep quality.
Measured: 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.
Measured: Baseline (the night before surgery), postoperative nights 1, 2 and 3
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperative days 1 and 2
Recovery of gastrointestinal function
Record the time of the first postoperative exhausting
Measured: Postoperative first 1 day
Recovery of gastrointestinal function
Record the time of the first postoperative bowel movement
Measured: Postoperative first 1 day
Recovery of gastrointestinal function
Record the time of the first postoperative feeding
Measured: 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.
Measured: Postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start25 Mar 2023
- Primary completion30 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing General Anesthesia Laparoscopic Uterine SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhuan Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhuan Zhang, Yangzhou University
- Investigators
- zhuan zhang, professor, Principal investigator, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715671
- Sponsor's protocol ID
- 20221217
- Status last verified
- May 2024
- First submitted
- 17 Dec 2022
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yuan B, Tian S, Pu X, Yin J, Wang M, Feng S, Lv X, Sun Y, Yao H, Li M, Li S, Zhang Z. Esketamine improves postoperative sleep quality in women undergoing gynecological laparoscopy: A prospective, randomized, double-blind, and controlled trial. Sleep Med. 2025 Dec;136:106852. doi: 10.1016/j.sleep.2025.106852. Epub 2025 Oct 14.
PubMed 41115350
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05715671
- Acronym / sponsor ID
- 20221217
- Keywords
- Esketamine, General anesthesia laparoscopic uterine surgery, Sleep quality, Recovery of gastrointestinal function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Zhuan ZhangUniversity, hospital or other
- Study start
- 25 Mar 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Esketamine for induction 0.15mg/kg and maintenance 0.15mg/kg/h | Experimental | Drug: esketamine |
| Esketamine for induction 0.3mg/kg and maintenance 0.3mg/kg/h | Experimental | Drug: esketamine |
| No esketamine | No intervention | – |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 40 and 65 years;
- ASA class I-III;
- Proposed laparoscopic total hysterectomy/myomectomy;
- Operative time ≥ 1 h;
- Body mass index of 18-30 kg/m2.
Key exclusion criteria (8 listed)
- Patient refusal;
- Known allergy to anesthetic drugs;
- Preoperative sleep disorder (Pittsburgh Sleep Quality Index [PSQI] > 7);
- 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;
- Long-term use of opioids or sedative-hypnotic drugs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esketamineThe 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. | Drug | Esketamine for induction 0.15mg/kg and maintenance 0.15mg/kg/h, Esketamine for induction 0.3mg/kg and maintenance 0.3mg/kg/h |
Primary outcome
Changes in the level of actigraphy
Time frame: 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
Time frame: 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.
12 secondary outcomes
Changes in the level of Mean Arterial Pressure
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
Time frame: Preoperatively, upon surgery completion, postoperative day 1
Changes in the level of Melatonin
Time frame: Preoperatively, upon surgery completion, postoperative day 1
Changes in the level of BDNF
Time frame: Preoperatively, upon surgery completion, postoperative day 1
Changes in the level of IL-10
Time frame: Preoperatively, upon surgery completion, postoperative day 1
Changes in the level of Heart Rate
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
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
Time frame: Postoperative days 1 and 2
Recovery of gastrointestinal function
Time frame: Postoperative first 1 day
Recovery of gastrointestinal function
Time frame: Postoperative first 1 day
Recovery of gastrointestinal function
Time frame: Postoperative first 1 day
Postoperative adverse reactions
Time frame: Postoperative day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Derived from this study: PubMed 41115350Yuan B, Tian S, Pu X, Yin J, Wang M, Feng S, Lv X, Sun Y, Yao H, Li M, Li S, Zhang Z. Esketamine improves postoperative sleep quality in women undergoing gynecological laparoscopy: A prospective, randomized, double-blind, and controlled trial. Sleep Med. 2025 Dec;136:106852. doi: 10.1016/j.sleep.2025.106852. Epub 2025 Oct 14.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zhuan zhang, professor principal investigator
Yangzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esketamine in people with Patients Undergoing General Anesthesia Laparoscopic Uterine Surgery, run by Zhuan Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the level of actigraphy (time frame: Baseline (the night before surgery), postoperative nights 1 and 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05715671, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.