Sleep DisturbanceNCT06284668
Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety
A study testing normal Saline, Esketamine and Remimazolam in people with Sleep Disturbance, run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
To explore and compare the effects of esketamine and remimazolam on postoperative sleep disturbance in patients undergoing oocyte retrieval Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- normal Saline, Esketamine and Remimazolam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2024to 20 May 2025
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-45 years old;
- American society of Aneshesiologists（ASA）physical status classification system is grade I-III;
- Elective surgery is proposed
- BMI of 19-30 kg/m2;
- Patients who agreed to enroll in this study voluntarily
Who cannot join
- Those who are known to be allergic to the drug ingredients in this study and their allergic constitution;
- Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
- History of neurological diseases; History of chronic pain; Drug and alcohol addiction; A long history of opioid use; Opiates were given 48 hours before surgery
- Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities;
- Respiratory insufficiency, respiratory failure;
- BMI<18 kg/m2 or BMI>30kg/m2;
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- Poor compliance, unable to complete the experiment according to the study plan; Participants who have participated in clinical trials of other drugs within the last 4 weeks;
- Preoperative Pittsburgh Sleep Quality Index (PSQI) higher than 7
- Any circumstances deemed unsuitable for inclusion by the researcher for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety in Patients Undergoing Oocyte Retrieval
To explore and compare the effects of esketamine and remimazolam on postoperative sleep disturbance in patients undergoing oocyte retrieval
Read the detailed description
Postoperative sleep disturbance (PSD) occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities, and have a high incidence in patients undergoing surgery. Postoperative sleep disorders can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative acute pain, and delay postoperative recovery.
Benzodiazepines have a certain sedative hypnotic anti-anxiety effect, and remimazolam as a new benzodiazepine, its sedative hypnotic anti-anxiety effect is worthy of further exploration. Esketamine is an N-methyl-D-aspartate(NMDA) receptor antagonist with analgesic and sedative effects, and is widely used in clinical treatment of refractory depression. For patients undergoing surgery, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on postoperative sleep disturbance is worth exploring.
- Conditions
- Sleep Disturbance
- Being tested
- normal Saline, Esketamine, Remimazolam
- Keywords
- Esketamine, Remimazolam, oocyte retrieval
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal SalineDrug
Also called Group of patients undergoing oocyte retrieval with normal saline
Patients undergoing oocyte retrieval were given 5ml 0.9% saline before anesthesia and surgery
EsketamineDrug
Also called Group of patients undergoing oocyte retrieval with esketamine
Patients undergoing oocyte retrieval were given esketamine 0.2mg/kg before anesthesia and surgery
RemimazolamDrug
Also called Group of patients undergoing oocyte retrieval with remimazolam
Patients undergoing oocyte retrieval were given remimazolam 0.2mg/kg before anesthesia and surgery
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group of patients undergoing oocyte retrieval with normal saline | Placebo comparator | Patients undergoing oocyte retrieval were given 5ml 0.9% saline before anesthesia and surgery Receives: Drug: normal Saline |
| Group of patients undergoing oocyte retrieval with esketamine | Active comparator | Patients undergoing oocyte retrieval were given esketamine 0.2mg/kg before anesthesia and surgery Receives: Drug: Esketamine |
| Group of patients undergoing oocyte retrieval with remimazolam | Active comparator | Patients undergoing oocyte retrieval were given remimazolam 0.2mg/kg before anesthesia and surgery Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative sleep disturbance on the first night after surgery
Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the first day after surgery.The AIS has a total of 8 items,with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.We asked the patients to fill out this questionnaire after the first postoperative night to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators.
Measured: the first night after surgery
Secondary outcomes (12)
The incidence of sleep disturbance one day before surgery
Patients completed the sleep quality scales(AIS, Athens Insomnia Scale) on the day before surgery.The AIS has a total of 8 items,with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia. We asked the patients to fill out this questionnaire on the day before surgery to evaluate patients' preoperative sleep quality. We recorded AIS scores as statistical indicators.
Measured: one day before surgery
The incidence of postoperative sleep disturbance on the second and third postoperative nights
Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the second and third day after surgery.The AIS has a total of 8 items,with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.We asked the patients to fill out this questionnaire after the second and third postoperative nights to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators.
Measured: the second and third nights after surgery
Postoperative anxiety
Patients completed the anxiety rating scales(HADS-A,Hospital Anxiety and Depression Scale-Anxiety subscale)on the day before surgery.HADS-A consists of 7 items,each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as anxiety.And we asked the patients to fill out this questionnaire on the 1 and 2 days after surgery again to evaluate the changes in anxiety. We recorded HADS-A scores as statistical indicators.
Measured: 1 day before surgery ,1 and 2 days after surgery
Postoperative depression
Patients completed the depression rating scales(HADS-D,Hospital Anxiety and Depression Scale-Depression subscale)on the day before surgery.HADS-D consists of 7 items,each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as depression.And we asked the patients to fill out this questionnaire on the 1 and 2 days after surgery again to evaluate the changes in depression. We recorded HADS-D scores as statistical indicators.
Measured: 1 day before surgery ,1 and 2 days after surgery
Pain Score (NRS)
The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.
Measured: 1 and 2 days after surgery
Mean intraoperative blood pressure
The mean intraoperative blood pressure was recorded
Measured: Intraoperative
Oxygen saturation
The mean intraoperative oxygen saturation was recorded
Measured: Intraoperative
Somatokinetic reaction
The number of intraoperative body movements was recorded
Measured: Intraoperative
Operation time
The duration of the patient's operation was recorded(up to 24 h)
Measured: Intraoperative
Duration of anesthesia
The patient's duration of anesthesia was recorded(up to 24 h)
Measured: Intraoperative
Time to walking down
Record the time from waking up to walking down(up to 24 h)
Measured: Within1 hour after surgery
Adverse event
All kinds of adverse events(PONV、hypotension、hypertension,etc) occurred in patients were recorded
Measured: Within 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start4 Mar 2024
- Primary completion10 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guolin Wang, Tianjin Medical University General Hospital
- Investigators
- Guolin Wang, Study director, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284668
- Sponsor's protocol ID
- GWang027
- Status last verified
- Nov 2025
- First submitted
- 1 Feb 2024
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety in Patients Undergoing Oocyte Retrieval
- ClinicalTrials.gov ID
- NCT06284668
- Acronym / sponsor ID
- GWang027
- Conditions
- Sleep Disturbance
- Keywords
- Esketamine, Remimazolam, oocyte retrieval
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 29 Feb 2024 (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.
To explore and compare the effects of esketamine and remimazolam on postoperative sleep disturbance in patients undergoing oocyte retrieval
Detailed description
Postoperative sleep disturbance (PSD) occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities, and have a high incidence in patients undergoing surgery. Postoperative sleep disorders can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative acute pain, and delay postoperative recovery.
Benzodiazepines have a certain sedative hypnotic anti-anxiety effect, and remimazolam as a new benzodiazepine, its sedative hypnotic anti-anxiety effect is worthy of further exploration. Esketamine is an N-methyl-D-aspartate(NMDA) receptor antagonist with analgesic and sedative effects, and is widely used in clinical treatment of refractory depression. For patients undergoing surgery, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on postoperative sleep disturbance is worth exploring.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Group of patients undergoing oocyte retrieval with normal saline | Placebo comparator | Drug: normal SalinePatients undergoing oocyte retrieval were given 5ml 0.9% saline before anesthesia and surgery |
| Group of patients undergoing oocyte retrieval with esketamine | Active comparator | Drug: EsketaminePatients undergoing oocyte retrieval were given esketamine 0.2mg/kg before anesthesia and surgery |
| Group of patients undergoing oocyte retrieval with remimazolam | Active comparator | Drug: RemimazolamPatients undergoing oocyte retrieval were given remimazolam 0.2mg/kg before anesthesia and surgery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-45 years old;
- American society of Aneshesiologists（ASA）physical status classification system is grade I-III;
- Elective surgery is proposed
- BMI of 19-30 kg/m2;
- Patients who agreed to enroll in this study voluntarily
Key exclusion criteria (9 listed)
- Those who are known to be allergic to the drug ingredients in this study and their allergic constitution;
- Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
- History of neurological diseases; History of chronic pain; Drug and alcohol addiction; A long history of opioid use; Opiates were given 48 hours before surgery
- Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities;
- Respiratory insufficiency, respiratory failure;
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 |
|---|---|---|
| normal SalineAlso: Group of patients undergoing oocyte retrieval with normal salinePatients undergoing oocyte retrieval were given 5ml 0.9% saline before anesthesia and surgery | Drug | Placebo Group of patients undergoing oocyte retrieval with normal saline |
| EsketamineAlso: Group of patients undergoing oocyte retrieval with esketaminePatients undergoing oocyte retrieval were given esketamine 0.2mg/kg before anesthesia and surgery | Drug | Group of patients undergoing oocyte retrieval with esketamine |
| RemimazolamAlso: Group of patients undergoing oocyte retrieval with remimazolamPatients undergoing oocyte retrieval were given remimazolam 0.2mg/kg before anesthesia and surgery | Drug | Group of patients undergoing oocyte retrieval with remimazolam |
Primary outcome
The incidence of postoperative sleep disturbance on the first night after surgery
Time frame: the first night after surgery
Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the first day after surgery.The AIS has a total of 8 items,with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.We asked the patients to fill out this questionnaire after the first postoperative night to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators.
12 secondary outcomes
The incidence of sleep disturbance one day before surgery
Time frame: one day before surgery
The incidence of postoperative sleep disturbance on the second and third postoperative nights
Time frame: the second and third nights after surgery
Postoperative anxiety
Time frame: 1 day before surgery ,1 and 2 days after surgery
Postoperative depression
Time frame: 1 day before surgery ,1 and 2 days after surgery
Pain Score (NRS)
Time frame: 1 and 2 days after surgery
Mean intraoperative blood pressure
Time frame: Intraoperative
Oxygen saturation
Time frame: Intraoperative
Somatokinetic reaction
Time frame: Intraoperative
Operation time
Time frame: Intraoperative
Duration of anesthesia
Time frame: Intraoperative
Time to walking down
Time frame: Within1 hour after surgery
Adverse event
Time frame: Within 3 days after surgery
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 26 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Guolin Wang study director
Tianjin Medical University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normal Saline, Esketamine and Remimazolam in people with Sleep Disturbance, run by Tianjin Medical University General Hospital 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 9 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 26 Nov 2025. 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. Some participants in this study may receive a placebo. 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?
The incidence of postoperative sleep disturbance on the first night after surgery (time frame: the first night after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2025.