Opioid-free Anesthesia in Thyroidectomies

Aretaieion University Hospital

Status: Enrolling

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

Treatments: Drug: dexmedetomidine-ketamine-lidocaine (DKL); Drug: remifentanil infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05243940

annie-rammi

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients
• American Society of Anesthesiologists (ASA) classification I-II
• elective thyroidectomy

Exclusion criteria

• body mass index (BMI) >35 kg/m2
• contraindications to local anesthetic administration
• systematic use of analgesic agents preoperatively
• chronic pain syndromes preoperatively
• neurological or psychiatric disease on treatment
• pregnancy
• severe hepatic or renal disease
• history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
• bradycardia(<55 beats/minute)
• drug or alcohol abuse
• language or communication barriers lack of informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

dexmedetomidine-ketamine-lidocaine (DKL) group

Active Comparator group

Description:

combination of dexmedetomidine-ketamine-lidocaine in one syringe

Treatment:

Drug: dexmedetomidine-ketamine-lidocaine (DKL)

remifentanil (control) group

Active Comparator group

Description:

remifentanil infusion (TCI Minto protocol)

Treatment:

Drug: remifentanil infusion