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| Name | Class |
|---|---|
| National and Kapodistrian University of Athens | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DOFA | Active Comparator | This arm will receive: Anesthesia Induction
Anesthesia Maintenance
PostOp Analgesia
|
|
| TIVOFA | Active Comparator | This arm will receive: Anesthesia Induction
Anesthesia Maintenance
PostOp Analgesia
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| opioid free anesthesia | Drug | OFA with Desflurane |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative trend of Cortisole | At baseline, at the end of the operation, 24 hours after surgery] | |
| Perioperative trend of Adrenaline | At baseline, at the end of the operation, 24 hours after surgery | |
| Perioperative trend of Noradrenaline | At baseline, at the end of the operation, 24 hours after surgery | |
| Perioperative trend of Dopamine | Time Frame: At baseline, at the end of the operation, 24 hours after surgery | |
| Perioperative trend of Prolactine | Time Frame: At baseline, at the end of the operation, 24 hours after surgery | |
| Perioperative trend of ACTH | Time Frame: At baseline, at the end of the operation, 24 hours after surgery | |
| Perioperative trend of Lactate | Time Frame: At baseline, at the end of the operation, 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Athens G. Gennimatas | Recruiting | Athens | 11527 | Greece |
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| Opiod Free Anesthesia with TCI ELEVELD | Drug | OFA without Desflurane use TCI Eleveld Model |
|
| Long-term and short-term quality of anesthesia recovery | Evaluation through the use of questionnaires QoR 40 | Post operatively Day 1, Day 2 Day 15 and Day 30 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D009767 | Obesity, Morbid |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077335 | Desflurane |
| ID | Term |
|---|---|
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
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