NCT05243940

Opioid-free Anesthesia in Thyroidectomies

Recovery Parameters and Nociception Levels in Opioid-free Versus Opioid Based Anesthesia for Thyroidectomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Aretaieion University Hospital · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus fentanyl analgesia in elective thyroidectomies. Recovery parameters and nociception levels throughout the operation will be evaluated

Detailed description

In the usual anesthetic practice opioids are often administered in the perioperative period for intraoperative analgesia to control the nociceptive pathway of pain and post-surgical pain management. However, in recent years, opioid Free Anesthesia (OFA) has become increasingly popular, in which opioid administration is avoided intraoperatively and minimized or avoided in the postoperative period. Opioid-free anesthesia (OFA) has been shown to decrease postoperative complications associated with opioids, include sedation, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression. Therefore, the investigators aim to perform this study to determine a goal-directed approach, which targets adequate antinociception (e.g., by measuring nociceptive/antinociceptive balance) that could reduce the negative effects of excessive drug infusion, prevent postoperative pain and improve patient outcomes.

Conditions

• Pain, Post Operative
• Pain, Acute
• Pain, Chronic
• Pain, Neuropathic
• Pain, Nociceptive
• Ketamine
• Dexmedetomidine
• Lidocaine
• Fentanyl
• Analgesia
• Analgesics
• Analgesics Non-narcotic

Interventions

Type	Name	Description
DRUG	dexmedetomidine-ketamine-lidocaine (DKL)	patients will be administered 0.25 mcg/kg Dexmedetomidine in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1 mL/10 kg of the solution containing ketamine, lidocaine and dexmedetomidine at predefined concentrations. As maintenance, they will be receiving 1mL/10kg/h of the aforementioned solution.
DRUG	remifentanil infusion	remifentanil infusion under the Minto model (target controlled infusion-TCI aiming at 4ng/ml blood concentration

Timeline

• Start date: 2022-03-07
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2022-02-17
• Last updated: 2023-04-26

Locations

1 site across 1 country: Greece