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| Name | Class |
|---|---|
| Aristotle University Of Thessaloniki | OTHER |
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The goal of this clinical trial is to compare Opioid Free and Opioid Based Anaesthesia in patients undergoing sleeve gastrectomy. The main questions it aims to answer are:
The Opioid Free Anaesthesia Group will be administered the Multimix infusion (Magnesium sulfate, dexmedetomidine, ketamine). The Opioid Based Anaesthesia Group will receive fentanyl as a bolus dose and remifentanil infusion.
Rescue fentanyl bolused will be injected as appropriate according to nociceptive level (NOL) values.
Opioid Free Anaesthesia has attracted the attention of clinicians since the outbreak of the opioid pandemic in the USA. It has been correlated with less intraoperative and postoperative opioid use. The Nociceptive Level Index algorithm allows for intraoperative monitoring of the nociceptive pathways and targeted pain management. Furthermore, it is known that morbidly obese patients may benefit from opioid sparing techniques.
Our aim is to investigate the effect of Opioid Free versus Opioid Based Anesthesia on postoperative pain in patients undergoing sleeve gastrectomy.
In this randomized, double blind clinical trial, patients will be allocated into two groups based on intraoperative pain management. Apart from recording postoperative pain scores, blood samples will be collected intraoperatively to evaluate the stress response among the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid Based Anaesthesia | Active Comparator | This arm will receive:
|
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| Opioid Free Anaesthesia | Active Comparator | This arm will receive
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid Free Anaesthesia | Drug |
Placebo infusions of normal saline will be prepared to enable blinding. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Visual Analogue Scale (VAS) score | The patient will be interviewed regarding postoperative pain using Visual Analogue Scale, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable | 6 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| First demand for supplementary analgesia | The time to the first demand for supplementary analgesia will be recorded for every patient enrolled. | Up to 24 hours postoperatively |
| Postoperative VAS score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| G.Gennimatas General Hospital | Recruiting | Athens | 11527 | Greece |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2023 | Feb 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Infusions will be prepared by independent staff not involved in the study. All preparations will be alike in the volume and appearance.
|
| Opioid based anesthesia | Drug |
Placebo infusions of normal saline will be prepared to enable blinding. |
|
The patient will be interviewed regarding postoperative pain using Visual Analogue Scale, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable
| 24 hours |
| Perioperative trend of Adrenaline | Blood will be collected to measure the plasma adrenaline levels | At baseline, at the end of the operation, 24 hours after surgery |
| Perioperative trend of Noradrenaline | Blood will be collected to measure the plasma Noradrenaline levels | At baseline, at the end of the operation, 24 hours after surgery |
| Perioperative trend of Cortisol | Blood will be collected to measure the plasma Cortisol levels | At baseline, at the end of the operation, 24 hours after surgery |
| Perioperative trend of Dopamine | Blood will be collected to measure the plasma Dopamine levels | At baseline, at the end of the operation, 24 hours after surgery |
| 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 |