EsketamineNCT06451627
Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery
A study testing Esketamine and saline in people with Esketamine and Sleep Disturbance, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about the effect of intraoperative esketamine infusion on postoperative sleep disturbance(PSD) of patients undergoing spinal surgery. The main aims to answer are: To explore the effect of intraoperative infusion of esketamine on the incidence of postoperative sleep… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Esketamine, Sleep Disturbance, Spinal Surgery
- What is being tested?
- Esketamine and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2024to 28 Jan 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old,
- American Society of Anesthesiologist (ASA) Physical Status classification I to III ;
- Patients scheduled to undergo elective spinal surgery under general anesthesia;
- Signed informed consent ;
Who cannot join
- BMI > 35kg / m2 ;
- Severe lesions of important organs and systems ;
- The estimated duration of surgery is more than 4 hours
- Patients who were retained tracheal intubation or admitted to intensive care unit (ICU) postoperatively.
- History of adverse reactions or contraindications to ketamine and esketamine ;
- Cognitive dysfunction, communication disorders ;
- Refused to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tian Tan Hospital
Beijing, 100070
Ruquan Han, M.D., Ph.D, 8610-59976660, ruquan.han@gmail.com
About this study
Official title: Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery：A Randomized Controlled Trial
The goal of this clinical trial is to learn about the effect of intraoperative esketamine infusion on postoperative sleep disturbance(PSD) of patients undergoing spinal surgery. The main aims to answer are:
- To explore the effect of intraoperative infusion of esketamine on the incidence of postoperative sleep disturbance and sleep quality in patients undergoing spinal surgery.
- To explore the effect of intraoperative infusion of esketamine on postoperative pain, anxiety and depression ; Participants will be patients undergoing spinal surgery with general anesthesia at Beijing Tiantan Hospital. 0.3mg/kg/h esketamine or saline will be infused during surgery . The incidence of sleep disturbance , sleep quality, pain scores, hospital anxiety and depression scores and perioperative adverse events after surgery will be investigated.
- Conditions
- Esketamine, Sleep Disturbance, Spinal Surgery
- Being tested
- Esketamine, saline
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Esketamine ( 50mg, dissolved in 50ml normal saline ) will be infused at a speed of 0.3mg / kg / h during surgery .
salineDrug
Saline will be infused at a speed of 0.3mg / kg / h during surgery .
| Study group | Role | What they receive |
|---|---|---|
| esketamine | Experimental | Esketamine ( 50mg, dissolved in 50ml normal saline ) will be infused at a speed of 0.3mg / kg / h during surgery .Total intravenous anesthesia with propofol ,remifentanil will be implemented for anesthesia maintenance based on the bispectral index(BIS) and keep BIS between 40-60 . Receives: Drug: Esketamine |
| saline | Placebo comparator | Saline will be infused at a speed of 0.3mg / kg / h during surgery .Total intravenous anesthesia with propofol ,remifentanil will be implemented for anesthesia maintenance based on the bispectral index(BIS) and keep BIS between 40-60 . Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative sleep disturbance(PSD) in patients undergoing spinal surgery
It will be evaluated by Athens Insomnia Scale (AIS) on the morning(8-10 am) of postoperative days 1-3, a score of 6 or higher will be defined as PSD.
Measured: during the first three days after surgery
Secondary outcomes (4)
objective sleep quality(total sleep time) of patients with spinal surgery assesssed by the sleep monitoring equipment.
It will be evaluated by an sleep monitoring equipment which can record total sleep time in hour.
Measured: on the postoperative day 1 and postoperative day 3 after surgery
The pain scores
Postoperative pain at rest and movement will be evaluated on the morning(8-10 am) of postoperative days 1-3 using NRS.0 indicating no pain, 10 indicating worst pain imaginable.
Measured: within 72hours after surgery
dosage of analgesics
The analgesic consumption(PCIA) and supplemental analgesics within 72h will be recorded.
Measured: within 72 hours after surgery
Postoperative hospital anxiety and depression scale ( HADS ) score.
Postoperative anxiety and depression scores will be measured by the Hospital Anxiety and Depression Scale, on the morning(8-10 am) of postoperative days (PODs) 1 and 3 , a score of 8 points or higher will be diagnosed as depression or anxiety.
Measured: on the postoperative day 1 and postoperative day 3 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start10 Jun 2024
- Primary completion28 Dec 2025 (estimated)
- Study completion28 Jan 2026 (estimated)
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 EsketamineStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451627
- Sponsor's protocol ID
- esketamine-JMY
- Status last verified
- Jun 2024
- First submitted
- 11 May 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data generated or analysed during this study will be included in published article. The data that support the findings of this study are available from the corresponding author, HW upon reasonable request.
Publications
Jian M, Chen Y, Wang S, Zhou Y, Liu H, Liang F, Han R, Wang H. Effect of esketamine on postoperative sleep disturbance in patients undergoing spinal surgery: a study protocol for a randomised, double-blinded, placebo-controlled clinical trial. BMJ Open. 2025 Mar 4;15(3):e090089. doi: 10.1136/bmjopen-2024-090089.
PubMed 40037679
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery：A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06451627
- Acronym / sponsor ID
- esketamine-JMY
- Conditions
- Esketamine, Sleep Disturbance, Spinal Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 28 Dec 2025 (estimated)
- Study completion
- 28 Jan 2026 (estimated)
- First posted
- 11 Jun 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.
The goal of this clinical trial is to learn about the effect of intraoperative esketamine infusion on postoperative sleep disturbance(PSD) of patients undergoing spinal surgery. The main aims to answer are:
- To explore the effect of intraoperative infusion of esketamine on the incidence of postoperative sleep disturbance and sleep quality in patients undergoing spinal surgery.
- To explore the effect of intraoperative infusion of esketamine on postoperative pain, anxiety and depression ; Participants will be patients undergoing spinal surgery with general anesthesia at Beijing Tiantan Hospital. 0.3mg/kg/h esketamine or saline will be infused during surgery . The incidence of sleep disturbance , sleep quality, pain scores, hospital anxiety and depression scores and perioperative adverse events after surgery will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| esketamine | Experimental | Drug: EsketamineEsketamine ( 50mg, dissolved in 50ml normal saline ) will be infused at a speed of 0.3mg / kg / h during surgery .Total intravenous anesthesia with propofol ,remifentanil will be implemented for anesthesia maintenance based on the bispectral index(BIS) and keep BIS between 40-60 . |
| saline | Placebo comparator | Drug: salineSaline will be infused at a speed of 0.3mg / kg / h during surgery .Total intravenous anesthesia with propofol ,remifentanil will be implemented for anesthesia maintenance based on the bispectral index(BIS) and keep BIS between 40-60 . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years old,
- American Society of Anesthesiologist (ASA) Physical Status classification I to III ;
- Patients scheduled to undergo elective spinal surgery under general anesthesia;
- Signed informed consent ;
Key exclusion criteria (7 listed)
- BMI > 35kg / m2 ;
- Severe lesions of important organs and systems ;
- The estimated duration of surgery is more than 4 hours
- Patients who were retained tracheal intubation or admitted to intensive care unit (ICU) postoperatively.
- History of adverse reactions or contraindications to ketamine and esketamine ;
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 |
|---|---|---|
| EsketamineEsketamine ( 50mg, dissolved in 50ml normal saline ) will be infused at a speed of 0.3mg / kg / h during surgery . | Drug | esketamine |
| salineSaline will be infused at a speed of 0.3mg / kg / h during surgery . | Drug | saline |
Primary outcome
The incidence of postoperative sleep disturbance(PSD) in patients undergoing spinal surgery
Time frame: during the first three days after surgery
It will be evaluated by Athens Insomnia Scale (AIS) on the morning(8-10 am) of postoperative days 1-3, a score of 6 or higher will be defined as PSD.
4 secondary outcomes
objective sleep quality(total sleep time) of patients with spinal surgery assesssed by the sleep monitoring equipment.
Time frame: on the postoperative day 1 and postoperative day 3 after surgery
The pain scores
Time frame: within 72hours after surgery
dosage of analgesics
Time frame: within 72 hours after surgery
Postoperative hospital anxiety and depression scale ( HADS ) score.
Time frame: on the postoperative day 1 and postoperative day 3 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Derived from this study: PubMed 40037679Jian M, Chen Y, Wang S, Zhou Y, Liu H, Liang F, Han R, Wang H. Effect of esketamine on postoperative sleep disturbance in patients undergoing spinal surgery: a study protocol for a randomised, double-blinded, placebo-controlled clinical trial. BMJ Open. 2025 Mar 4;15(3):e090089. doi: 10.1136/bmjopen-2024-090089.
- Individual participant dataSharing planned: Yes. All data generated or analysed during this study will be included in published article. The data that support the findings of this study are available from the corresponding author, HW upon reasonable request.
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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.
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 and saline in people with Esketamine and Sleep Disturbance, run by Beijing Tiantan 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 4 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: status not confirmed, as of the sponsor's last update on 24 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative sleep disturbance(PSD) in patients undergoing spinal surgery (time frame: during the first three days 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 NCT06451627, 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 24 Jan 2025.