Dexmedetomidine in Thoracoscopic Surgery: Opioid-Sparing Strategy

NCT05431322 | Completed

• 1 other identifier: KSVGH22-CT2-20
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use; Postoperative Pain

Keywords

Dexmedetomidine; Opioid-free anesthesia; Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• The difference in the perioperative dosage of fentanyl between the two groups.

  The difference in the perioperative dosage of fentanyl between the two groups.

  up to post operation day one

Secondary Outcomes (3)

• Postoperative pain scale

  up to post operation day one

• Perioperative hemodynamic parameters

  up to post operation day one

• Postoperative complications

  up to post operation day one

Study Arms (2)

Total intravenous anesthesia (TIVA) + Dexmedetomidine

EXPERIMENTAL

Total intravenous anesthetic drug is propofol. Dexmedetomidine is infused continuously.

Drug: Dexmedetomidine

Total intravenous anesthesia (TIVA)

NO INTERVENTION

Total intravenous anesthetic drug is propofol. The ordinary pain is controlled mainly by opioids.

Interventions

Dexmedetomidine DRUG

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.

Total intravenous anesthesia (TIVA) + Dexmedetomidine

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Pain, Postoperative; Carcinoma, Non-Small-Cell Lung

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 24, 2022
• Study Start: June 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

TW (1)