Opioid-free Anesthesia in Thyroidectomies

Sponsor

Aretaieion University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05243940

Collaborator

(none)

Enrollment

Location

Arms

22.9

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pain, Post Operative Pain, Acute Pain, Chronic Pain, Neuropathic Pain, Nociceptive Ketamine Dexmedetomidine Lidocaine Fentanyl Analgesia Analgesics Analgesics Non-narcotic	Drug: dexmedetomidine-ketamine-lidocaine (DKL) Drug: remifentanil infusion	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 7, 2022

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: dexmedetomidine-ketamine-lidocaine (DKL) group combination of dexmedetomidine-ketamine-lidocaine in one syringe	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.
Active Comparator: remifentanil (control) group remifentanil infusion (TCI Minto protocol)	Drug: remifentanil infusion remifentanil infusion under the Minto model (target controlled infusion-TCI aiming at 4ng/ml blood concentration

Arm

Intervention/Treatment

Active Comparator: dexmedetomidine-ketamine-lidocaine (DKL) group

combination of dexmedetomidine-ketamine-lidocaine in one syringe

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.

Active Comparator: remifentanil (control) group

remifentanil infusion (TCI Minto protocol)

Drug: remifentanil infusion

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

Outcome Measures

Primary Outcome Measures

change from baseline in Quality of Recovery (QoR)-40 score after surgery [24 hours postoperatively]
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)
pain score on arrival to Post-Anesthesia Care Unit (PACU) [immediately postoperatively]
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"
pain score at discharge from Post-Anesthesia Care Unit (PACU) [at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively]
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"
pain score 3 hours postoperatively [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"
pain score 6 hours postoperatively [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"
pain score 24 hours postoperatively [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"
Nociception Level [intraoperatively]
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

Secondary Outcome Measures

remifentanil requirement during anesthesia [intraoperatively]
rescue remifentanil required intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value
Post Anesthesia Care Unit (PACU) duration of stay [immediately postoperatively]
duration of patient stay at PACU
sedation on arrival to Post-Anesthesia Care Unit [immediately postoperatively]
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
sedation at discharge from Post-Anesthesia Care (PACU) Unit [at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively]
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
time to first request for analgesia [during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively]
the time for the first patient request for analgesia will be noted
morphine consumption in Post-Anesthesia Care Unit (PACU [immediately postoperatively]
mg of morphine requested during patient PACU stay
tramadol consumption in the first 48 hours [48 hours postoperatively]
patients will be followed for cumulative tramadol consumption for 48 hours postoperatively
sleep quality [24 hours postoperatively]
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)
first mobilization after surgery [24 hours postoperatively]
patients will be questioned regarding the time at which they mobilized after surgery
satisfaction from postoperative analgesia [24 hours postoperatively]
satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction
first fluid intake [24 hours postoperatively]
patients will be questioned regarding the time they had their first fluid intake
first solid intake [24 hours postoperatively]
patients will be questioned regarding the time they had their first solid intake
hospitalization time [96 hours postoperatively]
duration of hospital stay after surgery in hours
side effects intraoperatively [intraoperatively]
patients will be monitored for side-effects of the administered agents intraoperatively
side effects postoperatively [48 hours postoperatively]
patients will be monitored for side-effects of the administered agents postoperatively

Other Outcome Measures

time to emergence [up to 2-3 hours after start of surgery]]
time from sevoflurane discontinuation to first patient response (eye opening)
time to extubation [up to 2-3 hours after start of surgery]]
time from sevoflurane discontinuation to tracheal extubation