Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-03-07
2024-02-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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dexmedetomidine-ketamine-lidocaine (DKL) group
combination of dexmedetomidine-ketamine-lidocaine in one syringe
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.
remifentanil (control) group
remifentanil infusion (TCI Minto protocol)
remifentanil infusion
remifentanil infusion under the Minto model (target controlled infusion-TCI aiming at 4ng/ml blood concentration
Interventions
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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.
remifentanil infusion
remifentanil infusion under the Minto model (target controlled infusion-TCI aiming at 4ng/ml blood concentration
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) classification I-II
* elective thyroidectomy
Exclusion Criteria
* 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
25 Years
75 Years
ALL
No
Sponsors
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Aretaieion University Hospital
OTHER
Responsible Party
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Dr Kassiani Theodoraki
Professor of Anesthesiology
Principal Investigators
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KASSIANI THEODORAKI, MD, PhD, DESA
Role: PRINCIPAL_INVESTIGATOR
Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece
Locations
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General Hospital of Athens, "Georgios Gennimatas"
Athens, Attica, Greece
Countries
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Central Contacts
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Facility Contacts
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Antonia Dimakopoulou, MD, PhD
Role: backup
References
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Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.
Forget P. Opioid-free anaesthesia. Why and how? A contextual analysis. Anaesth Crit Care Pain Med. 2019 Apr;38(2):169-172. doi: 10.1016/j.accpm.2018.05.002. Epub 2018 Sep 13.
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.
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.
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.
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.
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.
Other Identifiers
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annie-rammi
Identifier Type: -
Identifier Source: org_study_id
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