Pain, Post Operative, Pain, Acute, Pain, Chronic, Pain, Neuropathic, Pain, Nociceptive, Ketamine, Dexmedetomidine, Lidocaine, Fentanyl, Analgesia, Analgesics, Analgesics Non-narcotic
Conditions
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.
Interventions
DRUGdexmedetomidine-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 under the Minto model (target controlled infusion-TCI aiming at 4ng/ml blood concentration
Sponsors
Aretaieion University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 postoperatively | 48 hours postoperatively | patients will be monitored for side-effects of the administered agents postoperatively |
| 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 |
| side effects intraoperatively | intraoperatively | patients will be monitored for side-effects of the administered agents intraoperatively |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Greece
Contacts
Primary ContactKASSIANI THEODORAKI, MD, PhD, DESA
Backup ContactRammi Devadze, MD
Outcome results
None listed