General AnesthesiaPhase 4NCT07308756
Impact of Perioperative Dexmedetomidine and Esketamine on Postoperative Quality of Recovery
A Phase 4 study testing Dexmedetomidine, Esketamine and Dexmedetomidine-esketamine in people with General Anesthesia and Surgery, run by Peking University First Hospital at 1 site in China.
Trial summary
For patients after surgery, quality of recovery has significant impacts on the prognosis, quality of life, and rational allocation of medical resources. Dexmedetomidine and esketamine have each been used during the perioperative period and improved postoperative analgesia and subjective sleep quality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Anesthesia, Surgery, Dexmedetomidine
- What is being tested?
- Dexmedetomidine, Esketamine and Dexmedetomidine-esketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 316 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2026to Apr 2027
- 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 or over;
- Scheduled to undergo surgery under general anesthesia, with an expected surgical duration of at least 1 hour;
- Required patient-controlled intravenous analgesia after surgery.
Who cannot join
- Unable to communicate preoperatively due to visual, auditory, or verbal barriers or other reasons;
- Severe bradycardia (heart rate <50 bpm), sick sinus syndrome, or grade 2 or higher atrioventricular block without pacemaker;
- History of hyperthyroidism or pheochromocytoma;
- History of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or intracranial hypertension;
- Intracranial tumor or neurosurgery;
- Severe liver dysfunction (Child-Pugh class C), renal failure (requiring renal replacement therapy), or American Society of Anesthesiologists class IV or higher;
- Enrolled in other clinical studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kun Wang, MD contact
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Dong-Xin Wang, MD, PhD, 8610 83572784, wangdongxin@hotmail.com
Kun Wang, MD, wk2021@bjmu.edu.cn
About this study
Official title: Impact of Perioperative Dexmedetomidine and Esketamine on Postoperative Quality of Recovery in Patients Undergoing General Anesthesia and Surgery: A 2×2 Factorial Randomized Trial
For patients after surgery, quality of recovery has significant impacts on the prognosis, quality of life, and rational allocation of medical resources. Dexmedetomidine and esketamine have each been used during the perioperative period and improved postoperative analgesia and subjective sleep quality. This 2x2 factorial trial is designed to explore the effects of dexmedetomidine, esketamine, and their combination on the quality of recovery in patients recovering from surgery under general anesthesia.
Read the detailed description
Surgical operation is an important therapeutic modality for surgical patients; quality of postoperative recovery has significant impacts on the prognosis, quality of life, and rational allocation of medical resources. Postoperative recovery is a complex process involving return of patients from surgery to baseline physiological and psychological status. Traditional indicators evaluating postoperative recovery mainly focus on physiological markers, length of hospital stay (LOS), and incidences of adverse events and complications. Recently, the quality of recovery (QoR) is increasingly used. QoR is subjectively reported by patients and includes multidimensional assessments on postoperative pain, cognitive function, sleep quality, and emotional stability.
Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, has anxiolytic, sedative, and analgesic effects. By activing α2-adrenergic receptors in the locus coeruleus, it activates the endogenous sleep pathways, and produce a state mimicking non-rapid eye movement (NREM) sleep. Clinical studies showed that perioperative use of low-dose dexmedetomidine improves sleep architecture, increases sleep efficiency, and prolongs total sleep time in non-mechanically ventilated patients. Furthermore, when used as an analgesic adjuvant, dexmedetomidine improves analgesia, reduces opioid consumption, and reduces opioid-related adverse events.
Ketamine, a non-competitive N-Methyl-D-aspartic (NMDA) receptor antagonist, exerts analgesic and anti-hyperalgesic effects by reducing transmission of noxious stimuli to the spinal cord. It is characterized by minimal respiratory and circulatory depression and excellent analgesic efficacy. In recent years, multiple studies confirmed that ketamine has antidepressant properties. Ketamine is a racemic mixture composed of S-ketamine (esketamine) and R-ketamine. Esketamine exhibits a stronger affinity for the NMDA receptor, with an effect approximately twice that of racemic ketamine. In clinical practice, esketamine has stronger analgesic effects and a lower incidence of adverse psychomimetic reactions. When used in combination with opioids, esketamine improved postoperative analgesia.
Previous studies showed that combined use of dexmedetomidine and esketamine might produce synergetic effects in improving sedation and analgesia. A recent trial found that low-dose dexmedetomidine-esketamine combination improved pain relief and subjective sleep quality in patients after scoliosis corrective surgery, without increasing side effects. It is therefore hypothesized that co-administration of dexmedetomidine and esketamine may enhance efficacy and optimize the quality of postoperative recovery. This 2x2 factorial trial is designed to explore the effects of dexmedetomidine, esketamine, and their combination on the quality of recovery in patients recovering from surgery under general anesthesia.
- Conditions
- General Anesthesia, Surgery, Dexmedetomidine, Esketamine, Quality of Recovery
- Being tested
- Dexmedetomidine, Esketamine, Dexmedetomidine-esketamine, Placebo
- Keywords
- General anesthesia, Surgery, Dexmedetomidine, Esketamine, Quality of recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
A loading dose of dexmedetomidine (0.2 ug/kg) is administered after anesthesia induction, followed by a continuous infusion of dexmedetomidineat a rate of 0.2 ug/kg/h until 30 minutes before the end of surgery.
Self-controlled analgesia is established with dexmedetomidine 100 ug and sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours.
EsketamineDrug
A loading dose of esketamine (0.1 mg/kg) is administered after anesthesia induction, followed by a continuous infusion of esketamineat a rate of 0.1 mg/kg/h until 30 minutes before the end of surgery.
Self-controlled analgesia is established with esketamine 50 mg and sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours.
Dexmedetomidine-esketamineDrug
A loading dose of dexmedetomidine (0.2 ug/kg) and esketamine (0.1 mg/kg) is administered after anesthesia induction, followed by a continuous infusion of dexmedetomidine at a rate of 0.2 ug/kg/h and esketamine at a rate of 0.1 mg/kg/h until 30 minutes before the end of surgery.
Self-controlled analgesia is established with dexmedetomidine 100 ug, esketamine 50 mg, and sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours.
PlaceboDrug
A loading dose of placebo (normal saline) is administered after anesthesia induction, followed by a continuous infusion of placebo at a rate same as above until 30 minutes before the end of surgery.
Self-controlled analgesia is established with sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | A loading dose of dexmedetomidine (0.2 ug/kg) is administered after anesthesia induction, followed by a continuous infusion of dexmedetomidineat a rate of 0.2 ug/kg/h until 30 minutes before the end of surgery.
Self-controlled analgesia is established with dexmedetomidine 100 ug and sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours. Receives: Drug: Dexmedetomidine |
| Esketamine | Experimental | A loading dose of esketamine (0.1 mg/kg) is administered after anesthesia induction, followed by a continuous infusion of esketamineat a rate of 0.1 mg/kg/h until 30 minutes before the end of surgery.
Self-controlled analgesia is established with esketamine 50 mg and sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours. Receives: Drug: Esketamine |
| Dexmedetomidine-esketamine | Experimental | A loading dose of dexmedetomidine (0.2 ug/kg) and esketamine (0.1 mg/kg) is administered after anesthesia induction, followed by a continuous infusion of dexmedetomidine at a rate of 0.2 ug/kg/h and esketamine at a rate of 0.1 mg/kg/h until 30 minutes before the end of surgery.
Self-controlled analgesia is established with dexmedetomidine 100 ug, esketamine 50 mg, and sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours. Receives: Drug: Dexmedetomidine-esketamine |
| Control | Placebo comparator | A loading dose of placebo (normal saline) is administered after anesthesia induction, followed by a continuous infusion of placebo at a rate same as above until 30 minutes before the end of surgery.
Self-controlled analgesia is established with sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery-15 (QoR-15) score
A 15-item scale that evaluate quality of recovery in five dimensions: pain, physiological comfort, physiological independence, psychological support, and emotional state. Scores range from 0 to 150 , with higher scores indicating better recovery quality.
Measured: At 24 hours after surgery
Secondary outcomes (3)
Quality of recovery-15 (QoR-15) score
QoR is a 15-item scale that evaluate quality of recovery in five dimensions: pain, physiological comfort, physiological independence, psychological support, and emotional state. Scores range from 0 to 150 , with higher scores indicating better recovery quality.
Measured: At 72 hours after surgery
Postoperative delirium (POD) within 4 days
Delirium will be assessed twice daily (8:00-10:00 and 18:00-20:00) using the 3-minute diagnostic interview for confusion assessment method-defined delirium (3D-CAM) or the confusion assessment method for the intensive care unit (CAM-ICU).
Measured: Up to 4 days after surgery
Incidence of delayed neurocognitive recovery at 5 days
Cognitive function will be assessed with the telephone-administered Montreal Cognitive Assessment (T-MoCA) at baseline and at 5 days or before hospital discharge after surgery. A decline of T-MoCA score of 1 standard deviation (SD) or more from baseline is defined as delayed neurocognitive recovery.
Measured: Up to 5 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 posted30 Dec 2025
- Study start5 Jan 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for General AnesthesiaStudies 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308756
- Sponsor's protocol ID
- 2025-0455
- Status last verified
- Apr 2026
- First submitted
- 15 Dec 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Cui F, Ma JH, Wang DX. Mini-dose esketamine-dexmedetomidine combination to supplement analgesia for patients after scoliosis correction surgery: a double-blind randomised trial. Br J Anaesth. 2023 Aug;131(2):385-396. doi: 10.1016/j.bja.2023.05.001. Epub 2023 Jun 9.
PubMed 37302963Guo J, Qiu D, Gu HW, Wang XM, Hashimoto K, Zhang GF, Yang JJ. Efficacy and safety of perioperative application of ketamine on postoperative depression: A meta-analysis of randomized controlled studies. Mol Psychiatry. 2023 Jun;28(6):2266-2276. doi: 10.1038/s41380-023-01945-z. Epub 2023 Jan 20.
PubMed 36670198Xie M, Liang Y, Deng Y, Li T. Effect of S-ketamine on Postoperative Pain in Adults Post-Abdominal Surgery: A Systematic Review and Meta-analysis. Pain Physician. 2023 Jul;26(4):327-335.
PubMed 37535771Wang S, Deng CM, Zeng Y, Chen XZ, Li AY, Feng SW, Xu LL, Chen L, Yuan HM, Hu H, Yang T, Han T, Zhang HY, Jiang M, Sun XY, Guo HN, Sessler DI, Wang DX. Efficacy of a single low dose of esketamine after childbirth for mothers with symptoms of prenatal depression: randomised clinical trial. BMJ. 2024 Apr 10;385:e078218. doi: 10.1136/bmj-2023-078218.
PubMed 38808490Persson J, Hasselstrom J, Maurset A, Oye I, Svensson JO, Almqvist O, Scheinin H, Gustafsson LL, Almqvist O. Pharmacokinetics and non-analgesic effects of S- and R-ketamines in healthy volunteers with normal and reduced metabolic capacity. Eur J Clin Pharmacol. 2002 Feb;57(12):869-75. doi: 10.1007/s002280100353.
PubMed 11936706Segmiller F, Ruther T, Linhardt A, Padberg F, Berger M, Pogarell O, Moller HJ, Kohler C, Schule C. Repeated S-ketamine infusions in therapy resistant depression: a case series. J Clin Pharmacol. 2013 Sep;53(9):996-8. doi: 10.1002/jcph.122. Epub 2013 Jul 24. No abstract available.
PubMed 23893490Canuso CM, Singh JB, Fedgchin M, Alphs L, Lane R, Lim P, Pinter C, Hough D, Sanacora G, Manji H, Drevets WC. Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study. Focus (Am Psychiatr Publ). 2019 Jan;17(1):55-65. doi: 10.1176/appi.focus.17105. Epub 2019 Jan 7.
PubMed 32015715Molero P, Ramos-Quiroga JA, Martin-Santos R, Calvo-Sanchez E, Gutierrez-Rojas L, Meana JJ. Antidepressant Efficacy and Tolerability of Ketamine and Esketamine: A Critical Review. CNS Drugs. 2018 May;32(5):411-420. doi: 10.1007/s40263-018-0519-3.
PubMed 29736744Bartova L, Papageorgiou K, Milenkovic I, Dold M, Weidenauer A, Willeit M, Winkler D, Kasper S. Rapid antidepressant effect of S-ketamine in schizophrenia. Eur Neuropsychopharmacol. 2018 Aug;28(8):980-982. doi: 10.1016/j.euroneuro.2018.05.007. Epub 2018 Jul 2.
PubMed 30041987Smith-Apeldoorn SY, Veraart JK, Spijker J, Kamphuis J, Schoevers RA. Maintenance ketamine treatment for depression: a systematic review of efficacy, safety, and tolerability. Lancet Psychiatry. 2022 Nov;9(11):907-921. doi: 10.1016/S2215-0366(22)00317-0.
PubMed 36244360Ma S, Chen M, Jiang Y, Xiang X, Wang S, Wu Z, Li S, Cui Y, Wang J, Zhu Y, Zhang Y, Ma H, Duan S, Li H, Yang Y, Lingle CJ, Hu H. Sustained antidepressant effect of ketamine through NMDAR trapping in the LHb. Nature. 2023 Oct;622(7984):802-809. doi: 10.1038/s41586-023-06624-1. Epub 2023 Oct 18.
PubMed 37853123Brinck EC, Tiippana E, Heesen M, Bell RF, Straube S, Moore RA, Kontinen V. Perioperative intravenous ketamine for acute postoperative pain in adults. Cochrane Database Syst Rev. 2018 Dec 20;12(12):CD012033. doi: 10.1002/14651858.CD012033.pub4.
PubMed 30570761Schnabel A, Meyer-Friessem CH, Reichl SU, Zahn PK, Pogatzki-Zahn EM. Is intraoperative dexmedetomidine a new option for postoperative pain treatment? A meta-analysis of randomized controlled trials. Pain. 2013 Jul;154(7):1140-9. doi: 10.1016/j.pain.2013.03.029. Epub 2013 Mar 27.
PubMed 23706726Wu XH, Cui F, Zhang C, Meng ZT, Wang DX, Ma J, Wang GF, Zhu SN, Ma D. Low-dose Dexmedetomidine Improves Sleep Quality Pattern in Elderly Patients after Noncardiac Surgery in the Intensive Care Unit: A Pilot Randomized Controlled Trial. Anesthesiology. 2016 Nov;125(5):979-991. doi: 10.1097/ALN.0000000000001325.
PubMed 27571256Lu W, Fu Q, Luo X, Fu S, Hu K. Effects of dexmedetomidine on sleep quality of patients after surgery without mechanical ventilation in ICU. Medicine (Baltimore). 2017 Jun;96(23):e7081. doi: 10.1097/MD.0000000000007081.
PubMed 28591048
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Perioperative Dexmedetomidine and Esketamine on Postoperative Quality of Recovery in Patients Undergoing General Anesthesia and Surgery: A 2×2 Factorial Randomized Trial
- ClinicalTrials.gov ID
- NCT07308756
- Acronym / sponsor ID
- 2025-0455
- Conditions
- General Anesthesia, Surgery, Dexmedetomidine, Esketamine, Quality of Recovery
- Keywords
- General anesthesia, Surgery, Dexmedetomidine, Esketamine, Quality of recovery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 30 Dec 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.
For patients after surgery, quality of recovery has significant impacts on the prognosis, quality of life, and rational allocation of medical resources. Dexmedetomidine and esketamine have each been used during the perioperative period and improved postoperative analgesia and subjective sleep quality. This 2x2 factorial trial is designed to explore the effects of dexmedetomidine, esketamine, and their combination on the quality of recovery in patients recovering from surgery under general anesthesia.
Detailed description
Surgical operation is an important therapeutic modality for surgical patients; quality of postoperative recovery has significant impacts on the prognosis, quality of life, and rational allocation of medical resources. Postoperative recovery is a complex process involving return of patients from surgery to baseline physiological and psychological status. Traditional indicators evaluating postoperative recovery mainly focus on physiological markers, length of hospital stay (LOS), and incidences of adverse events and complications. Recently, the quality of recovery (QoR) is increasingly used. QoR is subjectively reported by patients and includes multidimensional assessments on postoperative pain, cognitive function, sleep quality, and emotional stability.
Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, has anxiolytic, sedative, and analgesic effects. By activing α2-adrenergic receptors in the locus coeruleus, it activates the endogenous sleep pathways, and produce a state mimicking non-rapid eye movement (NREM) sleep. Clinical studies showed that perioperative use of low-dose dexmedetomidine improves sleep architecture, increases sleep efficiency, and prolongs total sleep time in non-mechanically ventilated patients. Furthermore, when used as an analgesic adjuvant, dexmedetomidine improves analgesia, reduces opioid consumption, and reduces opioid-related adverse events.
Ketamine, a non-competitive N-Methyl-D-aspartic (NMDA) receptor antagonist, exerts analgesic and anti-hyperalgesic effects by reducing transmission of noxious stimuli to the spinal cord. It is characterized by minimal respiratory and circulatory depression and excellent analgesic efficacy. In recent years, multiple studies confirmed that ketamine has antidepressant properties. Ketamine is a racemic mixture composed of S-ketamine (esketamine) and R-ketamine. Esketamine exhibits a stronger affinity for the NMDA receptor, with an effect approximately twice that of racemic ketamine. In clinical practice, esketamine has stronger analgesic effects and a lower incidence of adverse psychomimetic reactions. When used in combination with opioids, esketamine improved postoperative analgesia.
Previous studies showed that combined use of dexmedetomidine and esketamine might produce synergetic effects in improving sedation and analgesia. A recent trial found that low-dose dexmedetomidine-esketamine combination improved pain relief and subjective sleep quality in patients after scoliosis corrective surgery, without increasing side effects. It is therefore hypothesized that co-administration of dexmedetomidine and esketamine may enhance efficacy and optimize the quality of postoperative recovery. This 2x2 factorial trial is designed to explore the effects of dexmedetomidine, esketamine, and their combination on the quality of recovery in patients recovering from surgery under general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidineA loading dose of dexmedetomidine (0.2 ug/kg) is administered after anesthesia induction, followed by a continuous infusion of dexmedetomidineat a rate of 0.2 ug/kg/h until 30 minutes before the end of surgery. Self-controlled analgesia is established with dexmedetomidine 100 ug and sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours. |
| Esketamine | Experimental | Drug: EsketamineA loading dose of esketamine (0.1 mg/kg) is administered after anesthesia induction, followed by a continuous infusion of esketamineat a rate of 0.1 mg/kg/h until 30 minutes before the end of surgery. Self-controlled analgesia is established with esketamine 50 mg and sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours. |
| Dexmedetomidine-esketamine | Experimental | Drug: Dexmedetomidine-esketamineA loading dose of dexmedetomidine (0.2 ug/kg) and esketamine (0.1 mg/kg) is administered after anesthesia induction, followed by a continuous infusion of dexmedetomidine at a rate of 0.2 ug/kg/h and esketamine at a rate of 0.1 mg/kg/h until 30 minutes before the end of surgery. Self-controlled analgesia is established with dexmedetomidine 100 ug, esketamine 50 mg, and sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours. |
| Control | Placebo comparator | Drug: PlaceboA loading dose of placebo (normal saline) is administered after anesthesia induction, followed by a continuous infusion of placebo at a rate same as above until 30 minutes before the end of surgery. Self-controlled analgesia is established with sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours. |
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 or over;
- Scheduled to undergo surgery under general anesthesia, with an expected surgical duration of at least 1 hour;
- Required patient-controlled intravenous analgesia after surgery.
Key exclusion criteria (7 listed)
- Unable to communicate preoperatively due to visual, auditory, or verbal barriers or other reasons;
- Severe bradycardia (heart rate <50 bpm), sick sinus syndrome, or grade 2 or higher atrioventricular block without pacemaker;
- History of hyperthyroidism or pheochromocytoma;
- History of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or intracranial hypertension;
- Intracranial tumor or 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 |
|---|---|---|
| DexmedetomidineA loading dose of dexmedetomidine (0.2 ug/kg) is administered after anesthesia induction, followed by a continuous infusion of dexmedetomidineat a rate of 0.2 ug/kg/h until 30 minutes before the end of surgery. Self-controlled analgesia is established with dexmedetomidine 100 ug and sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours. | Drug | Dexmedetomidine |
| EsketamineA loading dose of esketamine (0.1 mg/kg) is administered after anesthesia induction, followed by a continuous infusion of esketamineat a rate of 0.1 mg/kg/h until 30 minutes before the end of surgery. Self-controlled analgesia is established with esketamine 50 mg and sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours. | Drug | Esketamine |
| Dexmedetomidine-esketamineA loading dose of dexmedetomidine (0.2 ug/kg) and esketamine (0.1 mg/kg) is administered after anesthesia induction, followed by a continuous infusion of dexmedetomidine at a rate of 0.2 ug/kg/h and esketamine at a rate of 0.1 mg/kg/h until 30 minutes before the end of surgery. Self-controlled analgesia is established with dexmedetomidine 100 ug, esketamine 50 mg, and sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours. | Drug | Dexmedetomidine-esketamine |
| PlaceboA loading dose of placebo (normal saline) is administered after anesthesia induction, followed by a continuous infusion of placebo at a rate same as above until 30 minutes before the end of surgery. Self-controlled analgesia is established with sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours. | Drug | Control |
Primary outcome
Quality of recovery-15 (QoR-15) score
Time frame: At 24 hours after surgery
A 15-item scale that evaluate quality of recovery in five dimensions: pain, physiological comfort, physiological independence, psychological support, and emotional state. Scores range from 0 to 150 , with higher scores indicating better recovery quality.
3 secondary outcomes
Quality of recovery-15 (QoR-15) score
Time frame: At 72 hours after surgery
Postoperative delirium (POD) within 4 days
Time frame: Up to 4 days after surgery
Incidence of delayed neurocognitive recovery at 5 days
Time frame: Up to 5 days 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 13 Apr 2026.
- Background: PubMed 37302963Zhang Y, Cui F, Ma JH, Wang DX. Mini-dose esketamine-dexmedetomidine combination to supplement analgesia for patients after scoliosis correction surgery: a double-blind randomised trial. Br J Anaesth. 2023 Aug;131(2):385-396. doi: 10.1016/j.bja.2023.05.001. Epub 2023 Jun 9.
- Background: PubMed 36670198Guo J, Qiu D, Gu HW, Wang XM, Hashimoto K, Zhang GF, Yang JJ. Efficacy and safety of perioperative application of ketamine on postoperative depression: A meta-analysis of randomized controlled studies. Mol Psychiatry. 2023 Jun;28(6):2266-2276. doi: 10.1038/s41380-023-01945-z. Epub 2023 Jan 20.
- Background: PubMed 37535771Xie M, Liang Y, Deng Y, Li T. Effect of S-ketamine on Postoperative Pain in Adults Post-Abdominal Surgery: A Systematic Review and Meta-analysis. Pain Physician. 2023 Jul;26(4):327-335.
- Background: PubMed 38808490Wang S, Deng CM, Zeng Y, Chen XZ, Li AY, Feng SW, Xu LL, Chen L, Yuan HM, Hu H, Yang T, Han T, Zhang HY, Jiang M, Sun XY, Guo HN, Sessler DI, Wang DX. Efficacy of a single low dose of esketamine after childbirth for mothers with symptoms of prenatal depression: randomised clinical trial. BMJ. 2024 Apr 10;385:e078218. doi: 10.1136/bmj-2023-078218.
- Background: PubMed 11936706Persson J, Hasselstrom J, Maurset A, Oye I, Svensson JO, Almqvist O, Scheinin H, Gustafsson LL, Almqvist O. Pharmacokinetics and non-analgesic effects of S- and R-ketamines in healthy volunteers with normal and reduced metabolic capacity. Eur J Clin Pharmacol. 2002 Feb;57(12):869-75. doi: 10.1007/s002280100353.
- Background: PubMed 23893490Segmiller F, Ruther T, Linhardt A, Padberg F, Berger M, Pogarell O, Moller HJ, Kohler C, Schule C. Repeated S-ketamine infusions in therapy resistant depression: a case series. J Clin Pharmacol. 2013 Sep;53(9):996-8. doi: 10.1002/jcph.122. Epub 2013 Jul 24. No abstract available.
- Background: PubMed 32015715Canuso CM, Singh JB, Fedgchin M, Alphs L, Lane R, Lim P, Pinter C, Hough D, Sanacora G, Manji H, Drevets WC. Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study. Focus (Am Psychiatr Publ). 2019 Jan;17(1):55-65. doi: 10.1176/appi.focus.17105. Epub 2019 Jan 7.
- Background: PubMed 29736744Molero P, Ramos-Quiroga JA, Martin-Santos R, Calvo-Sanchez E, Gutierrez-Rojas L, Meana JJ. Antidepressant Efficacy and Tolerability of Ketamine and Esketamine: A Critical Review. CNS Drugs. 2018 May;32(5):411-420. doi: 10.1007/s40263-018-0519-3.
- Background: PubMed 30041987Bartova L, Papageorgiou K, Milenkovic I, Dold M, Weidenauer A, Willeit M, Winkler D, Kasper S. Rapid antidepressant effect of S-ketamine in schizophrenia. Eur Neuropsychopharmacol. 2018 Aug;28(8):980-982. doi: 10.1016/j.euroneuro.2018.05.007. Epub 2018 Jul 2.
- Background: PubMed 36244360Smith-Apeldoorn SY, Veraart JK, Spijker J, Kamphuis J, Schoevers RA. Maintenance ketamine treatment for depression: a systematic review of efficacy, safety, and tolerability. Lancet Psychiatry. 2022 Nov;9(11):907-921. doi: 10.1016/S2215-0366(22)00317-0.
- Background: PubMed 37853123Ma S, Chen M, Jiang Y, Xiang X, Wang S, Wu Z, Li S, Cui Y, Wang J, Zhu Y, Zhang Y, Ma H, Duan S, Li H, Yang Y, Lingle CJ, Hu H. Sustained antidepressant effect of ketamine through NMDAR trapping in the LHb. Nature. 2023 Oct;622(7984):802-809. doi: 10.1038/s41586-023-06624-1. Epub 2023 Oct 18.
- Background: PubMed 30570761Brinck EC, Tiippana E, Heesen M, Bell RF, Straube S, Moore RA, Kontinen V. Perioperative intravenous ketamine for acute postoperative pain in adults. Cochrane Database Syst Rev. 2018 Dec 20;12(12):CD012033. doi: 10.1002/14651858.CD012033.pub4.
- Individual participant dataSharing planned: No
Related trials for General Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
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.
Kun Wang, MD contact
Dong-Xin Wang, MD, PhD principal investigator
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 and Dexmedetomidine-esketamine in people with General Anesthesia and 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 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. 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 Dong-Xin Wang, MD, PhD (8610 83572784, wangdongxin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery-15 (QoR-15) score (time frame: At 24 hours 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 NCT07308756, which also lists 26 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 13 Apr 2026.