Opioid-free Anesthesia in Thyroidectomies

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05243940
• Other study ID #: annie-rammi
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Analgesics
• Chronic Pain
• Dexmedetomidine
• Fentanyl
• Ketamine
• Lidocaine
• Neuralgia
• Nociceptive Pain
• Pain, Acute
• Pain, Chronic
• Pain, Neuropathic
• Pain, Post Operative
• Pain, Postoperative

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