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This prospective randomised clinical trial aims to assess the impact of intraoperative nociception monitoring using NOL on anesthetic management during major abdominal surgery. Additionally, the study will objectively evaluate using NOL how intravenous lidocaine administration, influences opioid requirements and the effect of this multimodal approach on early postoperative outcomes. The investigators hypothesize that NOL-guided intraoperative opioid administration reduces both intraoperative and postoperative opioid use, positively influencing 24-hour outcomes. Furthermore, the addition of intraoperative lidocaine in NOL-guided analgesia may further decrease opioid consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| + NOL + lidocaine group | Experimental | NOL guided analgesia and intravenous lidocaine infusion |
|
| - NOL - lidocaine group | No Intervention | group without NOL monitoring or lidocaine administration | |
| + NOL - lidocaine group | Experimental | NOL guided analgesia without intravenous lidocaine infusion |
|
| - NOL + lidocaine group | Experimental | group without NOL monitoring but with lidocaine intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine Intravenous Infusion | Drug | intravenous lidocaine 10 mg/ml continuous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative opioid use | We aim to examine the effect nociception level index monitoring in major abdominal surgery on intraoperative nociception management by measuring total opioid use in NOL monitored patients vs standard care according to the anesthesiologists judgement. Moreover, crossreference interventional arms will examine the effect of intraoperative administration of lidocaine in NOL and no NOL groups on intraoperative opioid use. Intraoperative opioid use will be time adjusted ( depending on the duration of surgery) and weight adjusted (depending on the weight of the patient)- mg of opioid/hour/kg | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative pulse | Mean pulse rate and peak pulse rate | intraoperative |
| Intraoperative blood pressure | Mean blood pressure and peak blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cristiana Osoian | Contact | +40743352189 | osoiancris@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Gastroenterology and Hepatology Institute Octavian Fodor | Recruiting | Cluj-Napoca | Cluj | Romania |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| NOL | Device | Intraoperative Nociception Level index monitoring and guided analgesia |
|
| intraoperative |
| Postoperative pain scores | VAS score at 15 minutes, 30 minute, 2 hours 4 hours, 12 hours and 24 hours | 24 hours |
| Postoperative opioid use | 24 hours |
| Lidocaine related adverse events | 24 hours |
| Opioid related adverse events | 24 hours |