Sleep DisturbanceNCT06388824
The Effect of Esketamine on Sleep Disturbance
A study testing normal saline and Esketamine in people with Sleep Disturbance, run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
To explore the efficacy of a single low dose of esketamine during surgical abortion in patients with sleep disturbance Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- normal saline and Esketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2024to 13 Nov 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older with sleep disturbance;
- American Society of Anesthesiologists physical status I-III;
- A gestational age below 12 weeks;
- Elective surgery is proposed;
- BMI of 19-30 kg/m2;
- Patients who agreed to enroll in this study voluntarily
Who cannot join
- Any contraindications to ketamine or esketamine;
- Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
- Respiratory insufficiency, respiratory failure;
- Bronchial asthma, severe hypertension, severe hepatic and renal dysfunction, severe cardiovascular disease, or hyperthyroidism;
- BMI<18 kg/m2 or BMI>30kg/m2;
- 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;
- 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: The Effect of a Single Low Dose of Esketamine During Surgical Abortion in Patients With Sleep Disturbance
To explore the efficacy of a single low dose of esketamine during surgical abortion in patients with sleep disturbance
Read the detailed description
Sleep disturbance occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities. Women who requires surgical abortion due to fetal anomaly or unwanted pregnancy often experience sleep disturbance. Severe sleep disturbance is a strong indicator for postoperative sleep disorders, which can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative pain, and delay postoperative recovery.
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 surgical abortion, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on sleep disturbance is worth exploring.
- Conditions
- Sleep Disturbance
- Being tested
- normal saline, Esketamine
- Keywords
- Esketamine, surgical abortion
- 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 sodium chloride injection
Patients undergoing surgical abortion received a single injection of 5ml 0.9% normal saline after the beginning of surgery
EsketamineDrug
Also called Esketamine Hydrochloride Injection
Patients undergoing surgical abortion received a single injection of 0.2mg/kg esketamine after the beginning of surgery
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group of patients undergoing surgical abortion with normal saline | Placebo comparator | Patients undergoing surgical abortion received a single injection of 5ml 0.9% normal saline after the beginning of surgery Receives: Drug: normal saline |
| Group of patients undergoing surgical abortion with esketamine | Active comparator | Patients undergoing surgical abortion received a single injection of 0.2mg/kg esketamine after the beginning of surgery Receives: Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of sleep disturbance on the first night after surgery
Patients completed the sleep quality scale (AIS, Athens Insomnia Scale) on the first night 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 (10)
The incidence of 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
The incidence of sleep disturbance on the seventh postoperative nights
Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the seventh 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 seventh postoperative nights to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators.
Measured: the seventh night 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, 2, 3 and 7 days after surgery again to evaluate the changes in anxiety. We recorded HADS-A scores as statistical indicators.
Measured: 1 day before surgery, 1, 2, 3 and 7 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, 2, 3 and 7 days after surgery again to evaluate the changes in depression. We recorded HADS-D scores as statistical indicators.
Measured: 1 day before surgery, 1, 2, 3 and 7 days after surgery
Pain intensity
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 hour after surgery, 1, 2, 3 and 7 days after surgery
Adverse event
All kinds of adverse events (nausea, vomiting, tachycardia, hypertension, somnolence, dizziness, hallucination, diplopia, etc) occurred in patients were recorded
Measured: Within 1 hour after surgery, within 1 day after surgery
preoperative hemoglobin concentration
Hemoglobin concentration in venous blood was measured.
Measured: the day before surgery
Human Chorionic Gonadotropin level
Human Chorionic Gonadotropin (HCG) in venous blood was measured.
Measured: within one week before surgery, within one week after surgery
The incidence of sleep disturbance on the day before surgery
Patients completed the sleep quality scale (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 the changes in sleep quality. We recorded AIS scores as statistical indicators.
Measured: the day before surgery
The incidence of sleep disturbance before surgery
Patients completed the sleep quality scale (PSQI, Pittsburgh sleep quality index) on the day before surgery. The PSQI has a total of 24 items(Including 19 self-evaluation items and 5 other evaluation items),of which the 19th self-evaluation item and 5 other self-evaluation items do not participate in scoring, while the remaining 18 self-evaluation items participate in scoring, with each item scoring 0-3 points. The total score of the scale ranges from 0 to 21 points, with a total score higher than 5 indicating poor sleep quality. We require patients to fill out this questionnaire one day before surgery to evaluate whether they have had sleep disorders in the past month.We recorded PSQI scores as statistical indicators.
Measured: the day before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start3 May 2024
- Primary completion7 Nov 2024
- Study completion13 Nov 2024
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 204 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, MD, PhD, Study director, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388824
- Sponsor's protocol ID
- GWang028
- Status last verified
- Feb 2025
- First submitted
- 25 Apr 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Song Z, Miao M, Huang F, Hu L, Yang X, Cui W, Yu Y, Wang G, Wang C, Zhang L. Effect of a single low-dose esketamine administration during surgical abortion on postoperative sleep disturbance: a randomized controlled trial. Nat Commun. 2025 Aug 14;16(1):7533. doi: 10.1038/s41467-025-62933-1.
PubMed 40804260
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Single Low Dose of Esketamine During Surgical Abortion in Patients With Sleep Disturbance
- ClinicalTrials.gov ID
- NCT06388824
- Acronym / sponsor ID
- GWang028
- Conditions
- Sleep Disturbance
- Keywords
- Esketamine, surgical abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 29 Apr 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 the efficacy of a single low dose of esketamine during surgical abortion in patients with sleep disturbance
Detailed description
Sleep disturbance occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities. Women who requires surgical abortion due to fetal anomaly or unwanted pregnancy often experience sleep disturbance. Severe sleep disturbance is a strong indicator for postoperative sleep disorders, which can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative pain, and delay postoperative recovery.
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 surgical abortion, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on sleep disturbance is worth exploring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group of patients undergoing surgical abortion with normal saline | Placebo comparator | Drug: normal salinePatients undergoing surgical abortion received a single injection of 5ml 0.9% normal saline after the beginning of surgery |
| Group of patients undergoing surgical abortion with esketamine | Active comparator | Drug: EsketaminePatients undergoing surgical abortion received a single injection of 0.2mg/kg esketamine after the beginning of surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18 years or older with sleep disturbance;
- American Society of Anesthesiologists physical status I-III;
- A gestational age below 12 weeks;
- Elective surgery is proposed;
- BMI of 19-30 kg/m2;
Key exclusion criteria (7 listed)
- Any contraindications to ketamine or esketamine;
- Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
- Respiratory insufficiency, respiratory failure;
- Bronchial asthma, severe hypertension, severe hepatic and renal dysfunction, severe cardiovascular disease, or hyperthyroidism;
- BMI<18 kg/m2 or BMI>30kg/m2;
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: sodium chloride injectionPatients undergoing surgical abortion received a single injection of 5ml 0.9% normal saline after the beginning of surgery | Drug | Placebo Group of patients undergoing surgical abortion with normal saline |
| EsketamineAlso: Esketamine Hydrochloride InjectionPatients undergoing surgical abortion received a single injection of 0.2mg/kg esketamine after the beginning of surgery | Drug | Group of patients undergoing surgical abortion with esketamine |
Primary outcome
The incidence of 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 night 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.
10 secondary outcomes
The incidence of sleep disturbance on the second and third postoperative nights
Time frame: the second and third nights after surgery
The incidence of sleep disturbance on the seventh postoperative nights
Time frame: the seventh night after surgery
Postoperative anxiety
Time frame: 1 day before surgery, 1, 2, 3 and 7 days after surgery
Postoperative depression
Time frame: 1 day before surgery, 1, 2, 3 and 7 days after surgery
Pain intensity
Time frame: 1 hour after surgery, 1, 2, 3 and 7 days after surgery
Adverse event
Time frame: Within 1 hour after surgery, within 1 day after surgery
preoperative hemoglobin concentration
Time frame: the day before surgery
Human Chorionic Gonadotropin level
Time frame: within one week before surgery, within one week after surgery
The incidence of sleep disturbance on the day before surgery
Time frame: the day before surgery
The incidence of sleep disturbance before surgery
Time frame: the day before 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 12 Feb 2025.
- Derived from this study: PubMed 40804260Song Z, Miao M, Huang F, Hu L, Yang X, Cui W, Yu Y, Wang G, Wang C, Zhang L. Effect of a single low-dose esketamine administration during surgical abortion on postoperative sleep disturbance: a randomized controlled trial. Nat Commun. 2025 Aug 14;16(1):7533. doi: 10.1038/s41467-025-62933-1.
- 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, MD, PhD 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 and Esketamine 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 6 inclusion and 7 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 12 Feb 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 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?
On the ClinicalTrials.gov record for NCT06388824, 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 12 Feb 2025.