Clinical trial

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

Name

annie-rammi

Description

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

Trial arms

Trial start

2022-03-07

Estimated PCD

2024-02-01

Trial end

2024-02-01

Status

Recruiting

Treatment

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.

Arms:

dexmedetomidine-ketamine-lidocaine (DKL) group

remifentanil infusion

remifentanil infusion under the Minto model (target controlled infusion-TCI aiming at 4ng/ml blood concentration

Arms:

remifentanil (control) group

Size

Primary endpoint

change from baseline in Quality of Recovery (QoR)-40 score after surgery

24 hours postoperatively

pain score on arrival to Post-Anesthesia Care Unit (PACU)

immediately postoperatively

pain score at discharge from Post-Anesthesia Care Unit (PACU)

at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively

pain score 3 hours postoperatively

3 hours postoperatively

pain score 6 hours postoperatively

6 hours postoperatively

pain score 24 hours postoperatively

24 hours postoperatively

Nociception Level

intraoperatively

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-04-26

1 organization

2 products

12 indications

Organization

Aretaieion University Hospital

Product

Dexmedetomidine-Ketamine-Lidocaine (DKL)

Indication

Pain

Indication