Pain, Anesthesia, Perioperative Care
Conditions
Brief summary
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.
Interventions
intravenous lidocaine 10 mg/ml continuous infusion
DEVICENOL
Intraoperative Nociception Level index monitoring and guided analgesia
Sponsors
Osoian Cristiana
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \> 18 years * ASA score I-III * surgery for gastric or hepatobiliary or pancreatic neoplasia
Exclusion criteria
* pregnancy * lactation * neuraxial or regional anesthesia * chronic treatment with drugs that can influence autonomic nervous system * diuretics or nitroglycerin administration on the day of surgery * severe neurological disability * severe hemodynamic instability * chronic pain * chronic opioid treatment * allergy to any of the study drugs * severe untreated disease or organ failure * pacemaker * emergency surgery * patient refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative opioid use | intraoperative | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood pressure | intraoperative | Mean blood pressure and peak blood pressure |
| Postoperative pain scores | 24 hours | VAS score at 15 minutes, 30 minute, 2 hours 4 hours, 12 hours and 24 hours |
| Intraoperative pulse | intraoperative | Mean pulse rate and peak pulse rate |
| Lidocaine related adverse events | 24 hours | — |
| Opioid related adverse events | 24 hours | — |
| Postoperative opioid use | 24 hours | — |
Countries
Romania
Contacts
Primary ContactCristiana Osoian
Outcome results
None listed