Recovery Parameters and Nociception Levels in Opioid-free Versus Opioid Based Anesthesia for Thyroidectomy
Overview
- Phase
- Not Applicable
- Intervention
- dexmedetomidine-ketamine-lidocaine (DKL)
- Conditions
- Pain, Post Operative
- Sponsor
- Aretaieion University Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- change from baseline in Quality of Recovery (QoR)-40 score after surgery
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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
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.
Investigators
Dr Kassiani Theodoraki
Professor of Anesthesiology
Aretaieion University Hospital
Eligibility Criteria
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
Arms & Interventions
dexmedetomidine-ketamine-lidocaine (DKL) group
combination of dexmedetomidine-ketamine-lidocaine in one syringe
Intervention: dexmedetomidine-ketamine-lidocaine (DKL)
remifentanil (control) group
remifentanil infusion (TCI Minto protocol)
Intervention: remifentanil infusion
Outcomes
Primary Outcomes
change from baseline in Quality of Recovery (QoR)-40 score after surgery
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
- morphine consumption in Post-Anesthesia Care Unit (PACU(immediately postoperatively)
- tramadol consumption in the first 48 hours(48 hours postoperatively)
- sleep quality(24 hours postoperatively)
- first mobilization after surgery(24 hours postoperatively)
- satisfaction from postoperative analgesia(24 hours postoperatively)
- first fluid intake(24 hours postoperatively)
- first solid intake(24 hours postoperatively)
- hospitalization time(96 hours postoperatively)
- side effects intraoperatively(intraoperatively)
- side effects postoperatively(48 hours postoperatively)