Clinical trial NCT05243940: Opioid-free Anesthesia in Thyroidectomies
Official title: Recovery Parameters and Nociception Levels in Opioid-free Versus Opioid Based Anesthesia for Thyroidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Post Operative
Pain, Acute
Pain, Chronic
Pain, Neuropathic
Pain, Nociceptive
Ketamine
Dexmedetomidine
Lidocaine
Fentanyl
Analgesia
Analgesics
Analgesics Non-narcotic
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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

Primary outcomes:
measure: change from baseline in Quality of Recovery (QoR)-40 score after surgery
timeFrame: 24 hours postoperatively
measure: pain score on arrival to Post-Anesthesia Care Unit (PACU)
timeFrame: immediately postoperatively
measure: pain score at discharge from Post-Anesthesia Care Unit (PACU)
timeFrame: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
measure: pain score 3 hours postoperatively
timeFrame: 3 hours postoperatively
measure: pain score 6 hours postoperatively
timeFrame: 6 hours postoperatively
measure: pain score 24 hours postoperatively
timeFrame: 24 hours postoperatively
measure: Nociception Level
timeFrame: intraoperatively
Secondary outcomes:
measure: remifentanil requirement during anesthesia
timeFrame: intraoperatively
measure: Post Anesthesia Care Unit (PACU) duration of stay
timeFrame: immediately postoperatively
measure: sedation on arrival to Post-Anesthesia Care Unit
timeFrame: immediately postoperatively
measure: sedation at discharge from Post-Anesthesia Care (PACU) Unit
timeFrame: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
measure: time to first request for analgesia
timeFrame: during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
measure: morphine consumption in Post-Anesthesia Care Unit (PACU
timeFrame: immediately postoperatively
measure: tramadol consumption in the first 48 hours
timeFrame: 48 hours postoperatively
measure: sleep quality
timeFrame: 24 hours postoperatively
measure: first mobilization after surgery
timeFrame: 24 hours postoperatively
measure: satisfaction from postoperative analgesia
timeFrame: 24 hours postoperatively
measure: first fluid intake
timeFrame: 24 hours postoperatively
measure: first solid intake
timeFrame: 24 hours postoperatively
measure: hospitalization time
timeFrame: 96 hours postoperatively
measure: side effects intraoperatively
timeFrame: intraoperatively
measure: side effects postoperatively
timeFrame: 48 hours postoperatively
Other outcomes:
measure: time to emergence
timeFrame: up to 2-3 hours after start of surgery]
measure: time to extubation
timeFrame: up to 2-3 hours after start of surgery]
Locations:
city: Athens
country: Greece
facility: General Hospital of Athens, "Georgios Gennimatas"
state: Attiki
Study officials:
affiliation: Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece
name: KASSIANI THEODORAKI, MD, PhD, DESA
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Martin JL, Koodie L, Krishnan AG, Charboneau R, Barke RA, Roy S. Chronic morphine administration delays wound healing by inhibiting immune cell recruitment to the wound site. Am J Pathol. 2010 Feb;176(2):786-99. doi: 10.2353/ajpath.2010.090457. Epub 2009 Dec 30.
citation: Ziemann-Gimmel P, Goldfarb AA, Koppman J, Marema RT. Opioid-free total intravenous anaesthesia reduces postoperative nausea and vomiting in bariatric surgery beyond triple prophylaxis. Br J Anaesth. 2014 May;112(5):906-11. doi: 10.1093/bja/aet551. Epub 2014 Feb 18.
citation: Song JY, Choi H, Chae M, Ko J, Moon YE. The effect of opioid-free anesthesia on the quality of recovery after gynecological laparoscopy: study protocol for a prospective randomized controlled trial. Trials. 2021 Mar 12;22(1):207. doi: 10.1186/s13063-021-05166-z.
citation: Ledowski T. Objective monitoring of nociception: a review of current commercial solutions. Br J Anaesth. 2019 Aug;123(2):e312-e321. doi: 10.1016/j.bja.2019.03.024. Epub 2019 Apr 30.
citation: Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):651-662. doi: 10.1111/anae.14582. Epub 2019 Feb 25.