NCT07308756

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for phase_4

Timeline
10mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Jan 2026Apr 2027

First Submitted

Initial submission to the registry

December 15, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

December 15, 2025

Last Update Submit

April 8, 2026

Conditions

SurgeryGeneral AnesthesiaDexmedetomidineEsketamineQuality of Recovery

Keywords

General anesthesiaSurgeryDexmedetomidineEsketamineQuality of recovery

Outcome Measures

Primary Outcomes (1)

  • 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.

    At 24 hours after surgery

Secondary Outcomes (3)

  • Quality of recovery-15 (QoR-15) score

    At 72 hours after surgery

  • Postoperative delirium (POD) within 4 days

    Up to 4 days after surgery

  • Incidence of delayed neurocognitive recovery at 5 days

    Up to 5 days after surgery

Other Outcomes (6)

  • Area under curve of pain intensity after surgery

    Up to 4 days after surgery

  • Cumulative subjective sleep quality score after surgery

    Up to 4 days after surgery

  • Length of hospital stay after surgery

    Up to 30 days after surgery

  • +3 more other outcomes

Study Arms (4)

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.

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.

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.

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.

Drug: Placebo

Interventions

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.

Control
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.

Dexmedetomidine
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.

Esketamine
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.

Dexmedetomidine-esketamine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Related Publications (26)

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  • Xie 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.

    PMID: 37535771BACKGROUND

  • Wang 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.

    PMID: 38808490BACKGROUND

  • Persson 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.

    PMID: 11936706BACKGROUND

  • Segmiller 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.

    PMID: 23893490BACKGROUND

  • Canuso 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.

    PMID: 32015715BACKGROUND

  • Molero 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.

    PMID: 29736744BACKGROUND

  • Bartova 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.

    PMID: 30041987BACKGROUND

  • Smith-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.

    PMID: 36244360BACKGROUND

  • Ma 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.

    PMID: 37853123BACKGROUND

  • Brinck 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.

    PMID: 30570761BACKGROUND

  • Schnabel 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.

    PMID: 23706726BACKGROUND

  • Wu 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.

    PMID: 27571256BACKGROUND

  • Lu 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.

    PMID: 28591048BACKGROUND

  • Huupponen E, Maksimow A, Lapinlampi P, Sarkela M, Saastamoinen A, Snapir A, Scheinin H, Scheinin M, Merilainen P, Himanen SL, Jaaskelainen S. Electroencephalogram spindle activity during dexmedetomidine sedation and physiological sleep. Acta Anaesthesiol Scand. 2008 Feb;52(2):289-94. doi: 10.1111/j.1399-6576.2007.01537.x. Epub 2007 Nov 14.

    PMID: 18005372BACKGROUND

  • Tasbihgou SR, Barends CRM, Absalom AR. The role of dexmedetomidine in neurosurgery. Best Pract Res Clin Anaesthesiol. 2021 Jul;35(2):221-229. doi: 10.1016/j.bpa.2020.10.002. Epub 2020 Oct 14.

    PMID: 34030806BACKGROUND

  • Mo Y, Zimmermann AE. Role of dexmedetomidine for the prevention and treatment of delirium in intensive care unit patients. Ann Pharmacother. 2013 Jun;47(6):869-76. doi: 10.1345/aph.1AR708.

    PMID: 23719785BACKGROUND

  • Xu M, Zhang G, Tang Y, Wang R, Yang J. Impact of Regional Anesthesia on Subjective Quality of Recovery in Patients Undergoing Thoracic Surgery: A Systematic Review and Meta-Analysis. J Cardiothorac Vasc Anesth. 2023 Sep;37(9):1744-1750. doi: 10.1053/j.jvca.2023.05.003. Epub 2023 May 5.

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  • Joe YE, Kang CM, Lee HM, Kim KJ, Hwang HK, Lee JR. Quality of Recovery of Patients Who Underwent Curative Pancreatectomy: Comparison of Total Intravenous Anesthesia Versus Inhalation Anesthesia Using the QOR-40 Questionnaire. World J Surg. 2021 Aug;45(8):2581-2590. doi: 10.1007/s00268-021-06117-0. Epub 2021 Apr 21.

    PMID: 33881579BACKGROUND

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MeSH Terms

Interventions

DexmedetomidineEsketamine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dong-Xin Wang, MD, PhD

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD, PhD

CONTACT

8610 83572784wangdongxin@hotmail.com

Kun Wang, MD

CONTACT

wk2021@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chairman, Department of Anaesthesiology

Study Record Dates

First Submitted

December 15, 2025

First Posted

December 30, 2025

Study Start

January 5, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)