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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05243940
Other study ID # annie-rammi
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 7, 2022
Est. completion date February 1, 2024

Study information

Verified date April 2023
Source Aretaieion University Hospital
Contact KASSIANI THEODORAKI, MD, PhD, DESA
Phone +306974634162
Email ktheodoraki@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date February 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 25 Years to 75 Years
Eligibility 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

Study Design


Intervention

Drug:
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

Locations

Country Name City State
Greece General Hospital of Athens, "Georgios Gennimatas" Athens Attiki

Sponsors (1)

Lead Sponsor Collaborator
Aretaieion University Hospital

Country where clinical trial is conducted

Greece, 

References & 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. — View Citation

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other time to emergence time from sevoflurane discontinuation to first patient response (eye opening) up to 2-3 hours after start of surgery]
Other time to extubation time from sevoflurane discontinuation to tracheal extubation up to 2-3 hours after start of surgery]
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 remifentanil requirement during anesthesia rescue remifentanil required intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value intraoperatively
Secondary Post Anesthesia Care Unit (PACU) duration of stay duration of patient stay at PACU immediately postoperatively
Secondary sedation on arrival to Post-Anesthesia Care Unit sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain immediately postoperatively
Secondary sedation at discharge from Post-Anesthesia Care (PACU) Unit sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Secondary time to first request for analgesia the time for the first patient request for analgesia will be noted during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Secondary morphine consumption in Post-Anesthesia Care Unit (PACU mg of morphine requested during patient PACU stay immediately postoperatively
Secondary tramadol consumption in the first 48 hours patients will be followed for cumulative tramadol consumption for 48 hours postoperatively 48 hours postoperatively
Secondary sleep quality subjective evaluation of sleep quality by patients, based on a sleep questionnaire (evaluation of sleep duration, number of nocturnal awakenings and marking of sleep quality) 24 hours postoperatively
Secondary first mobilization after surgery patients will be questioned regarding the time at which they mobilized after surgery 24 hours postoperatively
Secondary satisfaction from postoperative analgesia satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction 24 hours postoperatively
Secondary first fluid intake patients will be questioned regarding the time they had their first fluid intake 24 hours postoperatively
Secondary first solid intake patients will be questioned regarding the time they had their first solid intake 24 hours postoperatively
Secondary hospitalization time duration of hospital stay after surgery in hours 96 hours postoperatively
Secondary side effects intraoperatively patients will be monitored for side-effects of the administered agents intraoperatively intraoperatively
Secondary side effects postoperatively patients will be monitored for side-effects of the administered agents postoperatively 48 hours postoperatively
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