Clinical trial

Impact of Dexmedetomidine as an Opioid-Sparing Strategy in Thoracoscopic Surgery: A Randomised Controlled Trial

Name
KSVGH22-CT2-20
Description
Numerous studies in recent years have shown that the use of opioid-free analgesia can reduce opioid use and length of stay in the recovery room, as published in the journals Anesthesia \& Analgesia1. Compared with traditional opioid analgesic anesthesia, opioid-free analgesic anesthesia can be used to reduce postoperative respiratory complications, postoperative nausea and vomiting, and postoperative opioid needs. During surgery, opioid analgesics may have immunosuppressive effects, but different anesthesia/analgesia methods will change the individual's stress response, affect the human body's cellular immunity, and may even lead to changes in angiogenesis growth factors associated with cancer recurrence, so it is likely to affect the prognosis of cancer patients. In addition, Dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist, can replace opioids for pain relief during surgery, providing superior analgesia and reducing opioid use while reducing the need for general anesthetics amount, thus avoiding suppression of immune system function. A study in the Journal of Anaesthesiology Clinical Pharmacology pointed out that Dexmedetomidine can be used to replace opioid analgesics in surgical anesthesia, and there was no difference in the use of rescue opioid analgesics during and after surgery5. Several clinical studies have shown that opioid-free anesthesia is significantly associated with a lower incidence of respiratory complications and postoperative nausea and vomiting. Therefore, general anesthesia combined with Dexmedetomidine can be regarded as an opioid-free anesthesia strategy.
Trial arms
Trial start
2022-06-01
Estimated PCD
2023-10-31
Trial end
2023-10-31
Status
Completed
Treatment
Dexmedetomidine
Initially give loading dose with 0.5 mcg/kg for 10 min and then keep maintenance dose with 0.5 mcg/kg/h until two-lung ventilation.
Arms:
Total intravenous anesthesia (TIVA) + Dexmedetomidine
Size
73
Primary endpoint
The difference in the perioperative dosage of fentanyl between the two groups.
up to post operation day one
Eligibility criteria
Inclusion Criteria: * Age older than 20 years old and younger than 75 years old * Diagnosed as stage I-III non-small cell lung cancer * Received video-assisted thoracoscopic lung wedge resection or lobectomy Exclusion Criteria: * Cardiac arrhythmia , such as sinus bradycardia, sinus tachycardia, or high-degree atrioventricular block * Diagnosed acute myocardial myocardial infarction, congestive heart failure, or stroke within one year * Patient have underwent coronary artery bypass graft * Allergy to drug such as Propofol, Sevoflurane, Dexmedetomidine, NSAID, Lidocaine)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 73, 'type': 'ACTUAL'}}
Updated at
2024-01-29

1 organization

1 product

2 indications

Indication
Opioid Use