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Evaluation of the Stress Response in Anesthesia Use Inhalation Anesthetic (Desflurane) Versus TIVA for Bariatric Surgery

2026年5月1日更新者：Panagiotis Chatzistavridis、G.Gennimatas General Hospital

Evaluation of the Stress Response in Anesthesia Use Inhalation Anesthetic (Desflurane) Versus TIVA TCI ELEVELD Model for Bariatric Surgery

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

希腊
- - Athens、希腊、11527
    - 招聘中
    - General Hospital of Athens G. Gennimatas
    - 接触：
      
      Panagiotis Chatzistavridis
      
      电话号码：00306972871556
      
      邮箱：p.chatzistavridis@gna-gennimatas.gr
    - 首席研究员：
      
      Panagiotis Chatzistavridis

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：单身的

手臂数量

武器和干预

参与者组/臂	干预/治疗
有源比较器：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)	药品：opioid free anesthesia OFA with Desflurane 其他名称：地氟醚
有源比较器：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)	药品：Opiod Free Anesthesia with TCI ELEVELD OFA without Desflurane use TCI Eleveld Model

参与者组/臂

干预/治疗

有源比较器：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)

药品：opioid free anesthesia

OFA with Desflurane

其他名称：

地氟醚

有源比较器：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)

药品：Opiod Free Anesthesia with TCI ELEVELD

OFA without Desflurane use TCI Eleveld Model

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Perioperative trend of Cortisole 大体时间：At baseline, at the end of the operation, 24 hours after surgery]	At baseline, at the end of the operation, 24 hours after surgery]
Perioperative trend of Adrenaline 大体时间：At baseline, at the end of the operation, 24 hours after surgery	At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of Noradrenaline 大体时间：At baseline, at the end of the operation, 24 hours after surgery	At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of Dopamine 大体时间：Time Frame: At baseline, at the end of the operation, 24 hours after surgery	Time Frame: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of Prolactine 大体时间：Time Frame: At baseline, at the end of the operation, 24 hours after surgery	Time Frame: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of ACTH 大体时间：Time Frame: At baseline, at the end of the operation, 24 hours after surgery	Time Frame: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of Lactate 大体时间：Time Frame: At baseline, at the end of the operation, 24 hours after surgery	Time Frame: At baseline, at the end of the operation, 24 hours after surgery

次要结果测量

结果测量	措施说明	大体时间
Plasma levels of Propofol for patients receiving Propofol TCI 大体时间：Immediately after extubation		Immediately after extubation
Anesthesia related adverse effects reported, including intraoperative hemodynamic instability, postoperative hypoxemia, nausea and vomit 大体时间：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)		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 大体时间：Post operatively Day 1, Day 2 Day 15 and Day 30	Evaluation through the use of questionnaires QoR 40	Post operatively Day 1, Day 2 Day 15 and Day 30

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

G.Gennimatas General Hospital

合作者

National and Kapodistrian University of Athens

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年1月10日

初级完成 (估计的)

2027年2月28日

研究完成 (估计的)

2027年5月30日

研究注册日期

首次提交

2026年4月25日

首先提交符合 QC 标准的

2026年5月1日

首次发布 (实际的)

2026年5月6日

研究记录更新

最后更新发布 (实际的)

2026年5月6日

上次提交的符合 QC 标准的更新

2026年5月1日

最后验证

2026年5月1日

Evaluation of the Stress Response in Anesthesia Use Inhalation Anesthetic (Desflurane) Versus TIVA for Bariatric Surgery

Evaluation of the Stress Response in Anesthesia Use Inhalation Anesthetic (Desflurane) Versus TIVA TCI ELEVELD Model for Bariatric Surgery

研究概览

地位

条件

干预/治疗

研究类型

注册 (估计的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

合作者

研究记录日期

研究主要日期

学习开始 (实际的)

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

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

药物和器械信息、研究文件

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