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Enrolling by invitation NCT07125573

The Effect of Esketamine Combined With Dexmedetomidine on Postoperative Recovery Quality in Patients Undergoing Thoracoscopic Surgery

No phase Interventional Esketamine Plus Dexmedetomidine Affect Postoperative Quality Thoracoscopy Lung Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Saline Solution (NaCl 0,9%), Low-dose esketamine infusion, High-dose esketamine infusion.
Who it may be relevant to
Registry conditions: Esketamine Plus Dexmedetomidine Affect Postoperative Quality, Thoracoscopy, Lung Neoplasms. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Brief Summary:Video-assisted thoracoscopic surgery (VATS) has a wide range of applications, including the diagnosis and treatment of lung cancer, and has gradually replaced traditional open thoracotomy. VATS must routinely employ single-lung ventilation techniques. During single-lung ventilation, mechanical injury, lung collapse, imbalance in the ventilation-perfusion ratio, ischemia-reperfusion, and other pathological physiological changes may occur, leading to the release of a large number of inflammatory factors, triggering local and systemic inflammatory responses,increasing the incidence of postoperative complications, and affecting patient outcomes. Additionally, most patients undergoing thoracoscopic surgery experience acute postoperative pain. If acute postoperative pain is not adequately controlled, it may progress to chronic pain, affecting the quality of postoperative recovery. Currently, opioid medications are the primary drugs used to treat moderate to severe postoperative pain. However, adverse events associated with opioid medications may also affect the quality of postoperative recovery.The use of multimodal analgesia for postoperative pain management can control pain and reduce the need for opioid medications. Esketamine, a newly marketed intravenous anesthetic in China in recent years, is the dextrorotatory isomer of ketamine, and acts as a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor. Compared to ketamine, esketamine has higher potency, faster recovery time, and fewer adverse effects. Some clinical studies have shown that administration of esketamine reduces the intensity of postoperative pain and decreases the need for postoperative analgesics. Research has found that esketamine reduces the consumption of opioid medications and hyperalgesia postoperatively. Additionally, studies have shown that esketamine administration improves recovery quality by alleviating postoperative pain. Dexmedetomidine (DEX) is a selectiveα2 adrenergic receptor agonist with sedative and analgesic effects. Studies have shown that dexmedetomidine effectively reduces surgical inflammation, oxidative stress, and postoperative pain, thereby promoting postoperative recovery in surgical patients without increasing the risk of adverse reactions or complications. A meta-analysis indicated that dexmedetomidine administration alleviates postoperative pain and reduces postoperative nausea and vomiting (PONV). Current evidence suggests that the use of dexmedetomidine improves postoperative recovery quality. However, the effects of esketamine combined with dexmedetomidine on postoperative recovery quality in patients undergoing thoracoscopic surgery have not been reported. This study aims to investigate whether the combined administration of esketamine and dexmedetomidine can further improve postoperative recovery quality in patients undergoing thoracoscopic surgery.

Interventions

  • Drug Saline Solution (NaCl 0,9%)
    Administer 0.5 ug/kg of dexmedetomidine 10 minutes before surgery, and maintain at 0.4 ug/kg/h after intubation until 30 minutes before the end of surgery,Administer saline solution one minute after induction of anesthesia and continue until 30 minutes before the end of surgery.
  • Drug Low-dose esketamine infusion
    Administer 0.5 ug/kg of dexmedetomidine 10 minutes before surgery, and maintain at 0.4 ug/kg/h after intubation until 30 minutes before the end of surgery, administer esketamine 0.2 mg/kg 1 minute after induction of anesthesia, maintain at 2 μg/kg/min after intubation until 30 minutes before the end of surgery.
  • Drug High-dose esketamine infusion
    Administer 0.5 ug/kg of dexmedetomidine 10 minutes before surgery, and maintain at 0.4 ug/kg/h after intubation until 30 minutes before the end of surgery, Administer 0.2 mg/kg of esketamine 1 minute after induction of anesthesia, and maintain at 4 μg/kg/min after intubation until 30 minutes before the end of surgery.

Primary outcome measures

  • Record the QoR-15 scale scores for three groups of patients before surgery, on the first day after surgery, and on the third day after surgery. [Time frame: Record the QoR-15 scale scores for three groups of patients before surgery, on the first day after surgery, and on the third day after surgery.]

Eligibility criteria

Inclusion criteria

  • Age 18-65 years old;
  • BMI 18-30 kg/m2;
  • ASA classification I-III;
  • Patients undergoing thoracoscopic surgery;
  • No contraindications to the study drug;
  • Ability to express, communicate, and understand normally;
  • Both the patient and their family members agree to participate in this study and sign the informed consent form.

Exclusion criteria

  • Patients with poorly controlled or untreated hypertension;
  • Patients with untreated hyperthyroidism;
  • Patients with mental illness, cognitive impairment, or language barriers that prevent communication;
  • Patients with severe cardiopulmonary, hepatic, or renal dysfunction;
  • Patients with increased intracranial pressure;
  • Patients with a history of allergic reactions to any of the drugs used in the study;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • First Affiliated Hospital of Kunming Medical University — Kunming

Identifiers

NCT: NCT07125573 · (2025) Ethical Review L No. 81

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗