Recovery Parameters and Nociception Levels in Opioid-free Versus Opioid Based Anesthesia for Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change from baseline in Quality of Recovery (QoR)-40 score after surgery
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients
- •American Society of Anesthesiologists (ASA) classification I-II
- •elective thyroidectomy
排除标准
- •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
研究组 & 干预措施
dexmedetomidine-ketamine-lidocaine (DKL) group
combination of dexmedetomidine-ketamine-lidocaine in one syringe
干预措施: dexmedetomidine-ketamine-lidocaine (DKL) (Drug)
remifentanil (control) group
remifentanil infusion (TCI Minto protocol)
干预措施: remifentanil infusion (Drug)
结局指标
主要结局
change from baseline in Quality of Recovery (QoR)-40 score after surgery
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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)
研究者
Dr Kassiani Theodoraki
Professor of Anesthesiology
Aretaieion University Hospital