Opioid-free Anesthesia in Thyroidectomies
- Conditions
- Pain, NeuropathicKetaminePain, AcuteDexmedetomidineLidocaineFentanylAnalgesiaAnalgesicsAnalgesics Non-narcoticPain, Post Operative
- Interventions
- Drug: dexmedetomidine-ketamine-lidocaine (DKL)
- Registration Number
- NCT05243940
- Lead Sponsor
- Aretaieion University Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- adult patients
- American Society of Anesthesiologists (ASA) classification I-II
- elective thyroidectomy
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dexmedetomidine-ketamine-lidocaine (DKL) group dexmedetomidine-ketamine-lidocaine (DKL) combination of dexmedetomidine-ketamine-lidocaine in one syringe remifentanil (control) group remifentanil infusion remifentanil infusion (TCI Minto protocol)
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
General Hospital of Athens, "Georgios Gennimatas"
🇬🇷Athens, Attiki, Greece