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Impact of Intraoperative Non-invasive Analgesia Monitoring Using Nociception Level Index on Patient Management

ConditionsPainAnesthesiaPerioperative Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOsoian Cristiana

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age > 18 years

ASA score I-III

surgery for gastric or hepatobiliary or pancreatic neoplasia

Disqualifiers

pregnancy

lactation

neuraxial or regional anesthesia

chronic treatment with drugs that can influence autonomic nervous system

Trial design

Design model

Factorial

Treatments tested in this trial

  • Lidocaine Intravenous Infusion

    Drug

    intravenous lidocaine 10 mg/ml continuous infusion

  • NOL

    Device

    Intraoperative Nociception Level index monitoring and guided analgesia

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: + NOL + lidocaine groupExperimental treatment 2 interventions
Group B: - NOL - lidocaine groupNo intervention 0 interventions
Group C: + NOL - lidocaine groupExperimental treatment 1 intervention
Group D: - NOL + lidocaine groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
intraoperative

Secondary outcomes

1

Intraoperative pulse

Mean pulse rate and peak pulse rate

Time frame
intraoperative
2

Intraoperative blood pressure

Mean blood pressure and peak blood pressure

Time frame
intraoperative
3

Postoperative pain scores

VAS score at 15 minutes, 30 minute, 2 hours 4 hours, 12 hours and 24 hours

Time frame
24 hours
4

Postoperative opioid use

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Osoian Cristiana

Lead sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Sponsor institution

Source ClinicalTrials.gov
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