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

NCT07125573 | Enrolling By Invitation

• 1 other identifier: (2025) Ethical Review L No. 81
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esketamine Plus Dexmedetomidine Affect Postoperative Quality; Thoracoscopy; Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (3)

Saline solution + dexmedetomidine group

PLACEBO COMPARATOR

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: Saline Solution (NaCl 0,9%)

Low-dose esketamine + dexmedetomidine group

EXPERIMENTAL

Administer dexmedetomidine 0.5 μg/kg 10 minutes before surgery, maintain at 0.4 μg/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: Low-dose esketamine infusion

High-dose esketamine + dexmedetomidine group

EXPERIMENTAL

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.

Drug: High-dose esketamine infusion

Interventions

Saline Solution (NaCl 0,9%) DRUG

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.

Saline solution + dexmedetomidine group

Low-dose esketamine infusion DRUG

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.

Low-dose esketamine + dexmedetomidine group

High-dose esketamine infusion DRUG

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.

High-dose esketamine + dexmedetomidine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• First Affiliated Hospital of Kunming Medical University: lead

Study Sites (1)

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 6500000, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 15, 2025
• Study Start: May 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

CN (1)