Opioid Free Anesthesia and Continuous Post-operative Pulse Oximetry Monitoring in the Obese Patient: How About Another Approach?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- desaturation episode evaluation
研究概览
简要总结
Anaesthesia has three major components, analgesia, muscle relaxation and hypnosis.
For a long time, opioids have been covering the analgesia function. (1) When using opioids, an analgesic effect is obtained per-operatively, however, not without side-effects. Post-operative complications such as: respiratory depression, post-operative nausea and vomiting, pruritus, acute opioid tolerance and hyperalgesia, difficulty voiding and ileus, are well known.
Opioid usage is an important risk factor of postoperative desaturation. Postoperative desaturation can lead to severe hypoxemia and even tissue hypoxia, followed by obvious cardiologic and neurological complications.
Thus, in patients at risk, such as the obese patient, experts suggest reducing opioid usage.
Non-opiate protocols implemented on the obese patient have been published. Non-opiate protocols have been established using a combination of ketamine, lidocaine and an alpha-2 agonist.
The main purpose of this pilot study is to evaluate whether patients undergoing an opioid free anaesthesia regime experience less desaturation episodes during the first 24 h post-bariatric surgery than patients having received an opioid anaesthesia regime.
详细描述
Anaesthesia has three major components, analgesia, muscle relaxation and hypnosis.
For a long time, opioids have been covering the analgesia function. When using opioids, an analgesic effect is obtained per-operatively, however, not without side-effects. Post-operative complications such as: respiratory depression, post-operative nausea and vomiting, pruritus, acute opioid tolerance and hyperalgesia, difficulty voiding and ileus, are well known. These complications may lead to a prolonged hospital stay.
Opioid usage is an important risk factor of postoperative desaturation. Postoperative desaturation can lead to severe hypoxemia and even tissue hypoxia, followed by obvious cardiologic and neurological complications.
Thus, in patients at risk, such as the obese patient, experts suggest reducing opioid usage.
Authors have indeed published non-opiate protocols implemented on the obese patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing a gastric by-pass surgery will be screened.
- •Patients with an ASA physical status of I-II-III (BMI >30) will be included.
- •Knowledge of either French, English or Dutch will be required in order to be enrolled in this study.
排除标准
- •allergy or contraindications to one of the study drugs
- •renal failure
- •hepatic failure
- •hyperthyroidism
- •AV block 2 or 3
- •severe bradycardia
- •left ventricular failure
- •unstable blood pressure
- •severe respiratory disease
- •psychiatric disturbance.
研究组 & 干预措施
opioid free group
Opioid free group using dexmedetomidine, ketamine, lidocaine, MgSO4
干预措施: Opioid free (Combination Product)
Opioid group
Opioid group using sufentanil, lidocaine, clonidine
干预措施: opioid group (Combination Product)
结局指标
主要结局
desaturation episode evaluation
时间窗: first 24 hours postoperative
The primary outcome of this study is to evaluate desaturation episodes during the first 24 h post-bariatric surgery in patients having received an opioid or an opioid free anaesthesia. Desaturation is defined as a decrease of oxygen desaturation equal to or exceeding 4% of the baseline value. ODI (oxygen desaturation index), the total number of desaturation events divided by the total time of monitoring in hours, will be calculated to evaluate this outcome in both groups. In case of desaturation lasting longer than 10 seconds, oxygen (via nasal canula) will be administered as per post-anaesthesia care unit protocol. SP02 will be measured for 24 hours through non-invasive monitoring.
次要结局
未报告次要终点
研究者
Sarah Saxena
Dr
Université Libre de Bruxelles