Evaluation of the Stress Response in Anesthesia Use Inhalation Anesthetic (Desflurane) Versus TIVA TCI ELEVELD Model for Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Perioperative trend of Noradrenaline
研究概览
简要总结
The goal of this clinical trial is to compare the effects of Opioid Free Anesthesia (OFA) with and without volatile anesthetics (in this case desflurane) in patients undergoing bariatric surgery. The main question it aims to answer :
-Will there be a difference in the perioperative stress between patients receiving OFA with and without desflurane?
Participants will undergoing sleeve gastrectomy or gastric by pass, will be administered OFA with and without desflurane and blood tests (cortisole, ACTH,dopamine, PRL, adrenaline, noradrenaline, lactate) will be collected perioperatively to compare stress in the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Signed Informed Consent
- •ASA II-III
- •Morbid obesity confirmed diagnosis and approval for surgical treatment
- •Laparoscopic sleeve gastrectomy (LSG) or Gastric By pass (R-Y By pass /SASI/SADI AND one anastomosis by pass )
- •Preop respiratrory assessment conducted
- •Adequate organ and bone marrow function
排除标准
- •Patients declining or withdrawing consent
- •Patients unsuitabe with regards to compliance to treatment, according to the researcher's assessment
- •Bradycardia, AV block, , postural hypotension
- •QTcF>470msec
- •Known allergy or hypersensitiity to any of the medications administered
- •Stop-BANG score >6
- •Intraoperative administration of more than 8mg of prednisolone or equivalent
- •Patients who have received corticosteroids for durations >3 weeks at any point in their lifetime
- •Participation in other clinical trial for experimental product administered post operatively
- •Diagnosis of depression
研究组 & 干预措施
DOFA
This arm will receive:
Anesthesia Induction
- 40 mg/kg Magnesium sulfate in 100 ml N/S infusion
- 1 mcg/kg Dexmedetomidine, max total dose 100mcg in 50 ml N/S infusion
- 0.3 mg/kg Ketamine
- 0.2 ml/kg of the Mulimix regimen in 100 ml N/S infusion as a bolus (The -Mulimix regimen consists of 50mcg dexmedetomidine, 500 mg lidocaine and 50mg ketamine)
- 2-3mg/kg Propofol (for introduction )
- 4 mg Ondansetron
- 8mg Dexamethasone
- 0,9-1 mg/kg Rocuronium
- 40mg Parecoxib
Anesthesia Maintenance
- 0.2 ml/kg/h of the Multimix regimen in 100 ml N/S
- Desflurane
- Fentanyl rescue dose (1mcg/kg)
PostOp Analgesia
- Paracetamol 1gx4
- Parecoxib 40mg 1x2
- Tramadol 100mg (For pain, the patient may take a rescue medication as needed)
干预措施: opioid free anesthesia (Drug)
TIVOFA
This arm will receive:
Anesthesia Induction
- 40 mg/kg Magnesium sulfate in 100 ml N/S infusion
- 1 mcg/kg Dexmedetomidine, max total dose 100mcg in 50 ml N/S infusion
- 0.3 mg/kg Ketamine
- 0.2 ml/kg of the Mulimix regimen in 100 ml N/S infusion as a bolus (The -Mulimix regimen consists of 50mcg dexmedetomidine, 500 mg lidocaine and 50mg ketamine)
- Propofol Eleveld TCI model Start bolus 3mcg/ml and titrated according to EEG monitoring
- 4 mg Ondansetron
- 8mg Dexamethasone
- 0,9-1 mg/kg Rocuronium
- 40mg Parecoxib
Anesthesia Maintenance
- 0.2 ml/kg/h of the Multimix regimen in 100 ml N/S
- Fentanyl rescue dose (1mcg/kg)
PostOp Analgesia
- Paracetamol 1gx4
- Parecoxib 40mg 1x2
- Tramadol 100mg (For pain, the patient may take a rescue medication as needed)
干预措施: Opiod Free Anesthesia with TCI ELEVELD (Drug)
结局指标
主要结局
Perioperative trend of Noradrenaline
时间窗: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of Cortisole
时间窗: At baseline, at the end of the operation, 24 hours after surgery]
Perioperative trend of Adrenaline
时间窗: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of Dopamine
时间窗: Time Frame: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of Prolactine
时间窗: Time Frame: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of ACTH
时间窗: Time Frame: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of Lactate
时间窗: Time Frame: At baseline, at the end of the operation, 24 hours after surgery
次要结局
- Plasma levels of Propofol for patients receiving Propofol TCI(Immediately after extubation)
- Anesthesia related adverse effects reported, including intraoperative hemodynamic instability, postoperative hypoxemia, nausea and vomit(Baseline (preoperative), immediately postoperatively, and 24 hours postoperatively During surgery and through 24 hours after surgery, Immediately after extubation Up to 24 hours postoperatively, DAY 2 DAY 15 and DAY 30 postoperative (QoR-40))
- Long-term and short-term quality of anesthesia recovery(Post operatively Day 1, Day 2 Day 15 and Day 30)
研究者
Panagiotis Chatzistavridis
MD, MSC, PHD(c) Resident of Anaesthesiology
G.Gennimatas General Hospital