AdultsPhase 4NCT06859892
Dexmedetomidine-Esketamine Combination and Sleep Disturbances After Major Noncardiac Surgery
A Phase 4 study testing Dexmedetomidine-esketamine combination in people with Adults and Major Noncardiac Surgery, run by Peking University First Hospital at 1 site in China.
Trial summary
Sleep disturbances are common early after major surgery, and are associated with delayed recovery. A previous study showed that dexmedetomidine-esketamine combination as a supplement to patient-controlled intravenous analgesia improved postoperative analgesia and subjective sleep quality in patients after scoliosis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adults, Major Noncardiac Surgery, Dexmedetomidine
- What is being tested?
- Dexmedetomidine-esketamine combination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 476 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2025to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years.
- Scheduled for major noncardiac surgery (≥60 minutes) under general anesthesia with an expected end of surgery no later than 18:00 pm.
- Required patient-controlled intravenous analgesia after surgery.
Who cannot join
- Emergency surgery, transurethral surgery, organ transplantation.
- Pregnant or lactating women.
- Patients who need hypnotics for sleep disturbance or antidepressants for depression prior to surgery.
- History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.
- Inability to communicate due to coma, severe dementia, or speech disorders, endured hypoxic encephalopathy or traumatic brain injury, or after neurosurgery.
- Comorbid with hyperthyroidism and pheochromocytoma.
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- Preoperative left ventricular ejection fraction <30%, sick sinus syndrome, severe sinus bradycardia (heart rate <50 beats/min), atrioventricular block of degree II or higher without pacemaker implantation, or systolic blood pressure below 90 mmHg despite use of vasopressors.
- Diagnosed as sleep apnea, or judged to be at high risk of moderate-to-severe sleep apnea as assessed by STOP-Bang.
- Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (on dialysis), or ASA classification ≥IV.
- Hypersensitive to dexmedetomidine and/or esketamine.
- Other conditions that are deemed unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, 100034
Mo Li, MD, PhD
About this study
Official title: Effect of Dexmedetomidine-esketamine Combination on Sleep Disturbances After Major Noncardiac Surgery: a Single-center, Randomised, Double-blind, Placebo-controlled Trial
Sleep disturbances are common early after major surgery, and are associated with delayed recovery. A previous study showed that dexmedetomidine-esketamine combination as a supplement to patient-controlled intravenous analgesia improved postoperative analgesia and subjective sleep quality in patients after scoliosis correction surgery. The purpose of this trial is to test the hypothesis that dexmedetomidine-esketamine combination used as a supplement during general anesthesia and postoperative intravenous analgesia may reduce sleep disturbances in adult after major noncardiac surgery.
Read the detailed description
Sleep disturbances after surgery is usually manifested as sleep deprivation, altered circadian rhythm, and disturbed sleep structure. The reported incidence of sleep disturbances was 31.4% after gynecologic surgery, 31.9% after urologic surgery, and 35.9% after spine surgery. The occurrence of sleep disturbances is associated with worse perioperative outcomes, including aggravated pain intensity, increased delirium, higher risk of cardiovascular events, and delayed hospital discharge.
Dexmedetomidine is a high-specific alpha 2-adrenergic agonist with anxiolytic, sedative, and analgesic effects. When used during general anesthesia and for postoperative analgesia, dexmedetomidine is associated with improved analgesia and sleep quality. The effect of dexmedetomidine is dose-dependent. However, even commonly used dosage increases bradycardia and hypotension.
Ketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. Esketamine is the S-enantiomer of racemic ketamine with a higher affinity for NMDA receptors and is approximately twice as potent as racemic ketamine in analgesia. When used during general anesthesia and for postoperative analgesia, esketamine improves analgesia and reduces opioid consumption, but psychiatric symptoms may occur.
The sedative effect of dexmedetomidine is helpful to relieve psychiatric side effects of ketamine/esketamine. A previous study showed that dexmedetomidine-esketamine combination as a supplement to patient-controlled intravenous analgesia improved postoperative analgesia and subjective sleep quality in patients after scoliosis correction surgery.
This trial is designed to test the hypothesis that dexmedetomidine-esketamine combination used as a supplement during general anesthesia and postoperative intravenous analgesia may reduce sleep disturbances in adult after major noncardiac surgery.
- Conditions
- Adults, Major Noncardiac Surgery, Dexmedetomidine, Esketamine, Postoperative Sleep Disturbances
- Being tested
- Dexmedetomidine-esketamine combination, Placebo
- Keywords
- adults, major noncardiac surgery, dexmedetomidine, esketamine, postoperative sleep disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine-esketamine combinationDrug
Dexmedetomidine 0.4 μg/kg and esketamine 0.2 mg/kg is infused over 10 minutes before anesthesia induction. Dexmedetomidine 0.20 μg/kg/h and esketamine 0.10 mg/kg/h is then infused until 60 minutes before the expected end of surgery. Patient-controlled intravenous analgesia is established with 100 μg dexmedetomidine, 50 mg esketamine, and 100 μg sufentanil, diluted to 100 mL with normal saline, and programmed to deliver 2-mL boluses with a lock-out interval of 8 minutes and background infusion rate at 1 mL/h for up to 72 hours after surgery.
PlaceboDrug
Placebo (normal saline) is administered in the same rate and volume as that in the dexmedetomidine-esketamine group. Patient-controlled intravenous analgesia is established with 100 μg sufentanil, diluted to 100 mL with normal saline, and programmed to deliver 2-mL boluses with a lock-out interval of 8 minutes and background infusion rate at 1 mL/h for up to 72 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine-esketamine group | Experimental | Dexmedetomidine-esketamine combination is infused during general anesthesia and used as a supplement for patient-controlled intravenous analgesia after surgery. Receives: Drug: Dexmedetomidine-esketamine combination |
| Placebo group | Placebo comparator | Placebo (normal saline) is infused during general anesthesia and used as a supplement for patient-controlled intravenous analgesia after surgery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sleep disturbances within 3 days after surgery
Sleep disturbances are defined as Richards-Campbell Sleep Questionnaire (RCSQ) score below 50, based on assessments conducted daily between 8:00 am and 10:00 am during postoperative days 1 to 3.
Measured: Up to 3 days after surgery
Secondary outcomes (5)
Quality of recovery at 24 hours after surgery
Quality of recovery is assessed using the Quality of Recovery-15 (QoR-15) scale at 24 hours after surgery. The total QoR-15 scores are evaluated based on physical comfort (five items), emotional state (four items), psychological support (two items), physical independence (two items), and pain (two items) for QoR-15 questionnaire. Each item is scored from 0 to 10, and the possible total score ranges from 0 to 150, with higher scores representing better recovery quality after operation.
Measured: At 24 hours after surgery
Subjective sleep quality in the first 3 nights after surgery.
Subjective sleep quality is assessed daily (8:00 am to 10:00 am) using the Richards-Campbell Sleep Questionnaire (RCSQ) during the first 3 postoperative days. Richards-Campbell Sleep Questionnaire (RCSQ) comprises five items: sleep depth, sleep latency, awakenings, returning to sleep, and sleep quality. Each item is assessed with a 100-mm visual analog scale. The scores range from 0, indicating the worst possible sleep, to 100, indicating the best possible sleep. The total RCSQ sleep score is derived by summing up the individual scores on the five sleep items and dividing it by 5.
Measured: Up to 3 days after surgery.
Pain intensity both at rest and with movement during the first 3 postoperative days
Pain intensity is assessed with the numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain) twice daily (8:00 am to 10:00 am, and 18:00 pm to 20:00 pm) both at rest and with movement during the first 3 postoperative days.
Measured: Up to 3 days after surgery
Anxiety and depression on the third day after surgery
Postoperative anxiety and depression are assessed using the Hospital Anxiety and Depression Scale (HADS), with scores categorized as follows: 0-7 (negative), 8-10 (mild), 11-14 (moderate), and 15-21 (severe).
Measured: On the third day after surgery
Subjective sleep quality on the 30th day after surgery
Subjective sleep quality is assessed with the Pittsburgh Sleep Quality Index (PSQI) on the 30th postoperative day.
Measured: On the 30th day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start18 Mar 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for AdultsStudies of the same condition, open and under way.
- More trials run by Peking University First 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 476 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mo Li, Peking University First Hospital
- Investigators
- Dong-Xin Wang, Study chair, Dong-Xin Wang, MD, PhD, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859892
- Sponsor's protocol ID
- 2024-729
- Status last verified
- Mar 2025
- First submitted
- 28 Feb 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allen RW, Burney CP, Davis A, Henkin J, Kelly J, Judd BG, Ivatury SJ. Deep Sleep and Beeps: Sleep Quality Improvement Project in General Surgery Patients. J Am Coll Surg. 2021 Jun;232(6):882-888. doi: 10.1016/j.jamcollsurg.2021.02.010. Epub 2021 Mar 3.
PubMed 33675989Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14.
PubMed 35430086Kjolhede P, Langstrom P, Nilsson P, Wodlin NB, Nilsson L. The impact of quality of sleep on recovery from fast-track abdominal hysterectomy. J Clin Sleep Med. 2012 Aug 15;8(4):395-402. doi: 10.5664/jcsm.2032.
PubMed 22893770Gulam S, Xyrichis A, Lee GA. Still too noisy - An audit of sleep quality in trauma and orthopaedic patients. Int Emerg Nurs. 2020 Mar;49:100812. doi: 10.1016/j.ienj.2019.100812. Epub 2020 Jan 30.
PubMed 32007403Ruiz FS, Andersen ML, Guindalini C, Araujo LP, Lopes JD, Tufik S. Sleep influences the immune response and the rejection process alters sleep pattern: Evidence from a skin allograft model in mice. Brain Behav Immun. 2017 Mar;61:274-288. doi: 10.1016/j.bbi.2016.12.027. Epub 2017 Jan 7.
PubMed 28069386Chouchou F, Khoury S, Chauny JM, Denis R, Lavigne GJ. Postoperative sleep disruptions: a potential catalyst of acute pain? Sleep Med Rev. 2014 Jun;18(3):273-82. doi: 10.1016/j.smrv.2013.07.002. Epub 2013 Sep 24.
PubMed 24074687Fernandes NM, Nield LE, Popel N, Cantor WJ, Plante S, Goldman L, Prabhakar M, Manlhiot C, McCrindle BW, Miner SE. Symptoms of disturbed sleep predict major adverse cardiac events after percutaneous coronary intervention. Can J Cardiol. 2014 Jan;30(1):118-24. doi: 10.1016/j.cjca.2013.07.009. Epub 2013 Oct 16.
PubMed 24140074Lu Y, Li YW, Wang L, Lydic R, Baghdoyan HA, Shi XY, Zhang H. Promoting sleep and circadian health may prevent postoperative delirium: A systematic review and meta-analysis of randomized clinical trials. Sleep Med Rev. 2019 Dec;48:101207. doi: 10.1016/j.smrv.2019.08.001. Epub 2019 Aug 22.
PubMed 31505369Wang X, Hua D, Tang X, Li S, Sun R, Xie Z, Zhou Z, Zhao Y, Wang J, Li S, Luo A. The Role of Perioperative Sleep Disturbance in Postoperative Neurocognitive Disorders. Nat Sci Sleep. 2021 Aug 6;13:1395-1410. doi: 10.2147/NSS.S320745. eCollection 2021.
PubMed 34393534Meewisse AJG, Gribnau A, Thiessen SE, Stenvers DJ, Hermanides J, van Zuylen ML. Effect of time of day on outcomes in elective surgery: a systematic review. Anaesthesia. 2024 Dec;79(12):1325-1334. doi: 10.1111/anae.16395. Epub 2024 Aug 7.
PubMed 39108199Song B, Li Y, Teng X, Li X, Yang Y, Zhu J. Comparison of Morning and Evening Operation Under General Anesthesia on Intraoperative Anesthetic Requirement, Postoperative Sleep Quality, and Pain: A Randomized Controlled Trial. Nat Sci Sleep. 2020 Jul 16;12:467-475. doi: 10.2147/NSS.S257896. eCollection 2020.
PubMed 32765143Luo M, Song B, Zhu J. Sleep Disturbances After General Anesthesia: Current Perspectives. Front Neurol. 2020 Jul 8;11:629. doi: 10.3389/fneur.2020.00629. eCollection 2020.
PubMed 32733363Chung F, Liao P, Elsaid H, Shapiro CM, Kang W. Factors associated with postoperative exacerbation of sleep-disordered breathing. Anesthesiology. 2014 Feb;120(2):299-311. doi: 10.1097/ALN.0000000000000041.
PubMed 24158050Duan G, Wang K, Peng T, Wu Z, Li H. The Effects of Intraoperative Dexmedetomidine Use and Its Different Dose on Postoperative Sleep Disturbance in Patients Who Have Undergone Non-Cardiac Major Surgery: A Real-World Cohort Study. Nat Sci Sleep. 2020 Mar 12;12:209-219. doi: 10.2147/NSS.S239706. eCollection 2020.
PubMed 32210652Su X, Wang DX. Improve postoperative sleep: what can we do? Curr Opin Anaesthesiol. 2018 Feb;31(1):83-88. doi: 10.1097/ACO.0000000000000538.
PubMed 29120927
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine-esketamine Combination on Sleep Disturbances After Major Noncardiac Surgery: a Single-center, Randomised, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06859892
- Acronym / sponsor ID
- 2024-729
- Conditions
- Adults, Major Noncardiac Surgery, Dexmedetomidine, Esketamine, Postoperative Sleep Disturbances
- Keywords
- adults, major noncardiac surgery, dexmedetomidine, esketamine, postoperative sleep disturbances
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 476 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Mar 2025 (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.
Sleep disturbances are common early after major surgery, and are associated with delayed recovery. A previous study showed that dexmedetomidine-esketamine combination as a supplement to patient-controlled intravenous analgesia improved postoperative analgesia and subjective sleep quality in patients after scoliosis correction surgery. The purpose of this trial is to test the hypothesis that dexmedetomidine-esketamine combination used as a supplement during general anesthesia and postoperative intravenous analgesia may reduce sleep disturbances in adult after major noncardiac surgery.
Detailed description
Sleep disturbances after surgery is usually manifested as sleep deprivation, altered circadian rhythm, and disturbed sleep structure. The reported incidence of sleep disturbances was 31.4% after gynecologic surgery, 31.9% after urologic surgery, and 35.9% after spine surgery. The occurrence of sleep disturbances is associated with worse perioperative outcomes, including aggravated pain intensity, increased delirium, higher risk of cardiovascular events, and delayed hospital discharge.
Dexmedetomidine is a high-specific alpha 2-adrenergic agonist with anxiolytic, sedative, and analgesic effects. When used during general anesthesia and for postoperative analgesia, dexmedetomidine is associated with improved analgesia and sleep quality. The effect of dexmedetomidine is dose-dependent. However, even commonly used dosage increases bradycardia and hypotension.
Ketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. Esketamine is the S-enantiomer of racemic ketamine with a higher affinity for NMDA receptors and is approximately twice as potent as racemic ketamine in analgesia. When used during general anesthesia and for postoperative analgesia, esketamine improves analgesia and reduces opioid consumption, but psychiatric symptoms may occur.
The sedative effect of dexmedetomidine is helpful to relieve psychiatric side effects of ketamine/esketamine. A previous study showed that dexmedetomidine-esketamine combination as a supplement to patient-controlled intravenous analgesia improved postoperative analgesia and subjective sleep quality in patients after scoliosis correction surgery.
This trial is designed to test the hypothesis that dexmedetomidine-esketamine combination used as a supplement during general anesthesia and postoperative intravenous analgesia may reduce sleep disturbances in adult after major noncardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine-esketamine group | Experimental | Drug: Dexmedetomidine-esketamine combinationDexmedetomidine-esketamine combination is infused during general anesthesia and used as a supplement for patient-controlled intravenous analgesia after surgery. |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo (normal saline) is infused during general anesthesia and used as a supplement for patient-controlled intravenous analgesia after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥18 years.
- Scheduled for major noncardiac surgery (≥60 minutes) under general anesthesia with an expected end of surgery no later than 18:00 pm.
- Required patient-controlled intravenous analgesia after surgery.
Key exclusion criteria (11 listed)
- Emergency surgery, transurethral surgery, organ transplantation.
- Pregnant or lactating women.
- Patients who need hypnotics for sleep disturbance or antidepressants for depression prior to surgery.
- History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.
- Inability to communicate due to coma, severe dementia, or speech disorders, endured hypoxic encephalopathy or traumatic brain injury, or after neurosurgery.
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 |
|---|---|---|
| Dexmedetomidine-esketamine combinationDexmedetomidine 0.4 μg/kg and esketamine 0.2 mg/kg is infused over 10 minutes before anesthesia induction. Dexmedetomidine 0.20 μg/kg/h and esketamine 0.10 mg/kg/h is then infused until 60 minutes before the expected end of surgery. Patient-controlled intravenous analgesia is established with 100 μg dexmedetomidine, 50 mg esketamine, and 100 μg sufentanil, diluted to 100 mL with normal saline, and programmed to deliver 2-mL boluses with a lock-out interval of 8 minutes and background infusion rate at 1 mL/h for up to 72 hours after surgery. | Drug | Dexmedetomidine-esketamine group |
| PlaceboPlacebo (normal saline) is administered in the same rate and volume as that in the dexmedetomidine-esketamine group. Patient-controlled intravenous analgesia is established with 100 μg sufentanil, diluted to 100 mL with normal saline, and programmed to deliver 2-mL boluses with a lock-out interval of 8 minutes and background infusion rate at 1 mL/h for up to 72 hours after surgery. | Drug | Placebo group |
Primary outcome
Incidence of sleep disturbances within 3 days after surgery
Time frame: Up to 3 days after surgery
Sleep disturbances are defined as Richards-Campbell Sleep Questionnaire (RCSQ) score below 50, based on assessments conducted daily between 8:00 am and 10:00 am during postoperative days 1 to 3.
5 secondary outcomes
Quality of recovery at 24 hours after surgery
Time frame: At 24 hours after surgery
Subjective sleep quality in the first 3 nights after surgery.
Time frame: Up to 3 days after surgery.
Pain intensity both at rest and with movement during the first 3 postoperative days
Time frame: Up to 3 days after surgery
Anxiety and depression on the third day after surgery
Time frame: On the third day after surgery
Subjective sleep quality on the 30th day after surgery
Time frame: On the 30th day after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Background: PubMed 33675989Allen RW, Burney CP, Davis A, Henkin J, Kelly J, Judd BG, Ivatury SJ. Deep Sleep and Beeps: Sleep Quality Improvement Project in General Surgery Patients. J Am Coll Surg. 2021 Jun;232(6):882-888. doi: 10.1016/j.jamcollsurg.2021.02.010. Epub 2021 Mar 3.
- Background: PubMed 35430086Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14.
- Background: PubMed 22893770Kjolhede P, Langstrom P, Nilsson P, Wodlin NB, Nilsson L. The impact of quality of sleep on recovery from fast-track abdominal hysterectomy. J Clin Sleep Med. 2012 Aug 15;8(4):395-402. doi: 10.5664/jcsm.2032.
- Background: PubMed 32007403Gulam S, Xyrichis A, Lee GA. Still too noisy - An audit of sleep quality in trauma and orthopaedic patients. Int Emerg Nurs. 2020 Mar;49:100812. doi: 10.1016/j.ienj.2019.100812. Epub 2020 Jan 30.
- Background: PubMed 28069386Ruiz FS, Andersen ML, Guindalini C, Araujo LP, Lopes JD, Tufik S. Sleep influences the immune response and the rejection process alters sleep pattern: Evidence from a skin allograft model in mice. Brain Behav Immun. 2017 Mar;61:274-288. doi: 10.1016/j.bbi.2016.12.027. Epub 2017 Jan 7.
- Background: PubMed 24074687Chouchou F, Khoury S, Chauny JM, Denis R, Lavigne GJ. Postoperative sleep disruptions: a potential catalyst of acute pain? Sleep Med Rev. 2014 Jun;18(3):273-82. doi: 10.1016/j.smrv.2013.07.002. Epub 2013 Sep 24.
- Background: PubMed 24140074Fernandes NM, Nield LE, Popel N, Cantor WJ, Plante S, Goldman L, Prabhakar M, Manlhiot C, McCrindle BW, Miner SE. Symptoms of disturbed sleep predict major adverse cardiac events after percutaneous coronary intervention. Can J Cardiol. 2014 Jan;30(1):118-24. doi: 10.1016/j.cjca.2013.07.009. Epub 2013 Oct 16.
- Background: PubMed 31505369Lu Y, Li YW, Wang L, Lydic R, Baghdoyan HA, Shi XY, Zhang H. Promoting sleep and circadian health may prevent postoperative delirium: A systematic review and meta-analysis of randomized clinical trials. Sleep Med Rev. 2019 Dec;48:101207. doi: 10.1016/j.smrv.2019.08.001. Epub 2019 Aug 22.
- Background: PubMed 34393534Wang X, Hua D, Tang X, Li S, Sun R, Xie Z, Zhou Z, Zhao Y, Wang J, Li S, Luo A. The Role of Perioperative Sleep Disturbance in Postoperative Neurocognitive Disorders. Nat Sci Sleep. 2021 Aug 6;13:1395-1410. doi: 10.2147/NSS.S320745. eCollection 2021.
- Background: PubMed 39108199Meewisse AJG, Gribnau A, Thiessen SE, Stenvers DJ, Hermanides J, van Zuylen ML. Effect of time of day on outcomes in elective surgery: a systematic review. Anaesthesia. 2024 Dec;79(12):1325-1334. doi: 10.1111/anae.16395. Epub 2024 Aug 7.
- Background: PubMed 32765143Song B, Li Y, Teng X, Li X, Yang Y, Zhu J. Comparison of Morning and Evening Operation Under General Anesthesia on Intraoperative Anesthetic Requirement, Postoperative Sleep Quality, and Pain: A Randomized Controlled Trial. Nat Sci Sleep. 2020 Jul 16;12:467-475. doi: 10.2147/NSS.S257896. eCollection 2020.
- Background: PubMed 32733363Luo M, Song B, Zhu J. Sleep Disturbances After General Anesthesia: Current Perspectives. Front Neurol. 2020 Jul 8;11:629. doi: 10.3389/fneur.2020.00629. eCollection 2020.
- 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.
Dong-Xin Wang study chair
Dong-Xin Wang, MD, PhD, Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine-esketamine combination in people with Adults and Major Noncardiac Surgery, run by Peking University First 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 19 Mar 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mo Li, MD, PhD (+86 19801260665, 2361011139@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of sleep disturbances within 3 days after surgery (time frame: Up to 3 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 NCT06859892, which also lists 17 linked publications.
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 19 Mar 2025.