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

Osoian Cristiana

Status: Enrolling

Conditions: Perioperative Care; Pain; Anesthesia

Treatments: Drug: Lidocaine Intravenous Infusion; Device: NOL

Study type: Interventional

Funder types: Other

Identifiers

NCT06804434

NOL-1047

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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160 participants in 4 patient groups

+ NOL + lidocaine group

Experimental group

Description:

NOL guided analgesia and intravenous lidocaine infusion

Treatment:

Device: NOL

Drug: Lidocaine Intravenous Infusion

- NOL - lidocaine group

No Intervention group

Description:

group without NOL monitoring or lidocaine administration

+ NOL - lidocaine group

Experimental group

Description:

NOL guided analgesia without intravenous lidocaine infusion

Treatment:

Device: NOL

- NOL + lidocaine group

Experimental group

Description:

group without NOL monitoring but with lidocaine intravenous infusion

Treatment:

Drug: Lidocaine Intravenous Infusion