Comparison of Intensive and Conservative NOL®-Guided Analgesia Strategies During Opioid-free Anesthesia (OFANOL)
Comparison of Intensive and Conservative NOL®-Guided Analgesia Strategies During Opioid-free Anesthesia for Bariatric Surgery: A Prospective Randomized Controlled Trial
Participants will be randomized to one of two predefined NOL®-guided analgesia strategies during bariatric surgery performed under OFA. In both groups the NOL® index will be continuously monitored intraoperatively and dexmedetomidine will be administered according to the assigned study algorithm based on the NOL® index using lean body weight (LBW) for dosing.
研究概览
详细说明
The study aims to evaluate whether different intraoperative target ranges of the NOL® index during bariatric surgery performed under OFA are associated with differences in postoperative analgesic consumption and postoperative pain control without significant differences in intraoperative hemodynamics. Based on the physiological mechanisms outlined above, we hypothesize that during OFA with alpha-2 agonists such as dexmedetomidine, intensified NOL® target ranges (potentially 0-10) may be appropriate compared to the established range of 10-25 for opioid based TIVA. If this hypothesis is confirmed, clinical implications would include the need to establish OFA-specific NOL® target ranges to avoid under-treatment of nociception when applying TIVA-derived thresholds to OFA patients. Conversely, using inappropriately high NOL® targets derived from opioid-based anesthesia might lead to inadequate pain control and to excessive administration of analgesics postoperatively.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Isabel Marcolino, Dr. med.
- 电话号码：+41 44 733 2891
- 邮箱：isabel.marcolino@spital-limmattal.ch
研究联系人备份
- 姓名：Cornelia Stress, MSc
- 电话号码：+41 44 736 85 76
- 邮箱：Cornelia.stress@spital-limmattal.ch
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Signed informed consent
- Age ≥ 18 years
- bariatric surgery (sleeve/bypass/Re-Do)
Exclusion Criteria:
- Patients with contraindications for dexmedetomidine or lidocaine
- Lack of ability to follow the study procedure, e.g. due to severe language barriers, mental disorders, dementia - Patients requiring preoperative or postoperative treatment in the intensive care unit (ICU) (excluding Obstructive sleep apnea syndrome (OSAS))
- Patients with conditions precluding the use of the NOL® sensor, such as neuromuscular deficits affecting hand function
- BMI <25 kg/m2
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Intensive NOL®-guided strategy
Induction: An initial dexmedetomidine bolus of 0.3ug/kg LBW will be administered, followed by a continuous infusion of 0.3 ug/kg LBW/h. |
Induction: An initial dexmedetomidine bolus of 0.3ug/kg LBW will be administered, followed by a continuous infusion of 0.3 ug/kg LBW/h. |
|
实验性的：Conservative NOL®-guided strategy
Induction: An initial dexmedetomidine bolus of 0.3ug/kg LBW will be administered, followed by a continuous infusion of 0.1 ug/kg LBW/h. |
Induction: An initial dexmedetomidine bolus of 0.3ug/kg LBW will be administered, followed by a continuous infusion of 0.1 ug/kg LBW/h. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative pain intensity Measured by the numeric rating scale (NRS) in the Post-anesthesia care unit (PACU)
大体时间：At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
To evaluate whether an intensive NOL®-guided analgesia strategy reduces postoperative pain intensity in the post-anesthesia care unit (PACU) compared to a conservative NOL®-guided analgesia strategy in patients undergoing bariatric surgery under OFA. |
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
|
Postoperative pain intensity Measured by the Behavioral Pain Scale (BPS) in the Post-anesthesia care unit (PACU)
大体时间：At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
To evaluate whether an intensive NOL®-guided analgesia strategy reduces postoperative pain intensity in the post-anesthesia care unit (PACU) compared to a conservative NOL®-guided analgesia strategy in patients undergoing bariatric surgery under OFA. |
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Difference between postoperative pain intensity measurement using the Behavioral Pain Scale (BPS) (outcome 1) and numeric rating scale (NRS) (outcome 2) in the Post-anesthesia care unit (PACU)
大体时间：At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
Difference between the outcome 1 and outcome 2 |
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
|
Total opioid consumption in the Post-anesthesia care unit (PACU)
大体时间：At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
Morphin (mg), Oxynorm (mg), Oxycodon/Naloxon (mg) |
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
|
- Total non-opioid analgesic consumption in the Post-anesthesia care unit (PACU)
大体时间：At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
Paracetamol (mg), Metamizol (mg), Ketamin (mg) |
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
|
- Total non-opioid analgesic consumption in the Post-anesthesia care unit (PACU)
大体时间：At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
Lidocain-P (mg/kgLBW/h) |
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
|
- Total non-opioid analgesic consumption in the Post-anesthesia care unit (PACU)
大体时间：At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
Ketamin-Perfusor (mg/h) |
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
|
- Incidence of Postoperative nausea and vomiting (PONV)
大体时间：At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
The proportion of patients who experience at least one episode of postoperative nausea, retching, or vomiting, or who require the administration of any antiemetic rescue medication (such as Ondansetron, Metoclopramide, Domperidone, or Itinerol). |
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
|
- Richmond Agitation-Sedation Scale (RASS) scores during Post-anesthesia care unit (PACU) stay
大体时间：At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
|
|
- Quality of Recovery-15 (QoR-15) score on postoperative day 1
大体时间：At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Safety endpoints
大体时间：At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
- measures of intraoperative hemodynamic stability, including the incidence of hypotension, bradycardia, hypertension, tachycardia, and vasoactive medication use - occurrence of AEs and SAEs during the study period |
At the Date of Surgery + 1 day after at Post-anesthesia care unit (PACU): two assessments within 2 consequent days
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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其他研究编号
- 2026-01332
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