Opioid-free Anesthesia in Thyroidectomies

NCT05243940 | Unknown

• 1 other identifier: annie-rammi
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (7)

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

  The QoR-40 is used to measure functional recovery and has been validated in patients undergoing general surgical procedures. Five general quality-of-recovery dimensions are measured within the QoR-40: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is graded on a five-point Likert scale, and the global scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)

  24 hours postoperatively

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

  pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  immediately postoperatively

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

  pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

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

• pain score 3 hours postoperatively

  pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  3 hours postoperatively

• pain score 6 hours postoperatively

  pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  6 hours postoperatively

• pain score 24 hours postoperatively

  pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  24 hours postoperatively

• Nociception Level

  Nociception Level as measured via the NOL (Nociception Level) index, whose values vary from 0 to 100 (100 represents the maximum level of nociception and 0 represents total absence of nociception). The aim of the current study will be to record percentage of operative time during which NOL levels will be \<25

  intraoperatively

Secondary Outcomes (15)

• remifentanil requirement during anesthesia

  intraoperatively

• Post Anesthesia Care Unit (PACU) duration of stay

  immediately postoperatively

• sedation on arrival to Post-Anesthesia Care Unit

  immediately postoperatively

• sedation at discharge from Post-Anesthesia Care (PACU) Unit

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

• time to first request for analgesia

  during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively

Other Outcomes (2)

• time to emergence

  up to 2-3 hours after start of surgery]

• time to extubation

  up to 2-3 hours after start of surgery]

Study Arms (2)

dexmedetomidine-ketamine-lidocaine (DKL) group

ACTIVE COMPARATOR

combination of dexmedetomidine-ketamine-lidocaine in one syringe

Drug: dexmedetomidine-ketamine-lidocaine (DKL)

remifentanil (control) group

ACTIVE COMPARATOR

remifentanil infusion (TCI Minto protocol)

Drug: remifentanil infusion

Interventions

dexmedetomidine-ketamine-lidocaine (DKL) DRUG

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.

dexmedetomidine-ketamine-lidocaine (DKL) group

remifentanil infusion DRUG

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

remifentanil (control) group

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aretaieion University Hospital: lead

Study Sites (1)

General Hospital of Athens, "Georgios Gennimatas"

Athens, Attica, Greece

RECRUITING

Related Publications (7)

• 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.

  PMID: 24829420 BACKGROUND

• 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.

  PMID: 29775728 BACKGROUND

• 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.

  PMID: 20042674 BACKGROUND

• 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.

  PMID: 24554545 BACKGROUND

• 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.

  PMID: 33712080 BACKGROUND

• 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.

  PMID: 31047645 BACKGROUND

• 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.

  PMID: 30802933 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Chronic Pain; Neuralgia; Nociceptive Pain; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations

Study Officials

• KASSIANI THEODORAKI, MD, PhD, DESA

  Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KASSIANI THEODORAKI, MD, PhD, DESA

CONTACT

+306974634162; ktheodoraki@hotmail.com

Rammi Devadze, MD

CONTACT

+306949535388; gurdevadze@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 17, 2022
• Study Start: March 7, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)