Actively Recruiting
Impact of Intraoperative Non-invasive Analgesia Monitoring Using Nociception Level Index on Patient Management
Led by Osoian Cristiana · Updated on 2025-02-03
160
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how using the Nociception Level (NOL) index to monitor pain during major abdominal surgery affects anesthesia management. The study also investigates how giving intravenous lidocaine alongside NOL-guided analgesia influences the need for opioids and early recovery after surgery. The trial aims to see if NOL-guided opioid use reduces opioid consumption during and after surgery and if adding lidocaine further decreases opioid use. Participants are divided into four groups: one with NOL monitoring plus lidocaine infusion, one with neither NOL nor lidocaine, one with NOL monitoring without lidocaine, and one with lidocaine without NOL monitoring. Lidocaine is given as a continuous intravenous infusion during surgery. The study uses these groups to compare how pain monitoring and lidocaine affect opioid use and patient outcomes. During the trial, researchers will measure opioid use during surgery as the primary outcome. They will also track heart rate, blood pressure, pain scores, and opioid use for 24 hours after surgery. Side effects related to lidocaine and opioids will be monitored as well. Participants will be followed through the perioperative period to assess these outcomes and safety measures.
CONDITIONS
Brief Title
Impact of Intraoperative Non-invasive Analgesia Monitoring Using Nociception Level Index on Patient Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- ASA score I to III
- Scheduled for surgery for gastric, hepatobiliary, or pancreatic tumors
You will not qualify if you...
- Pregnancy
- Breastfeeding
- Use of neuraxial or regional anesthesia
- Chronic treatment with drugs affecting the autonomic nervous system
- Use of diuretics or nitroglycerin on the day of surgery
- Severe neurological disability
- Severe hemodynamic instability
- Chronic pain
- Chronic opioid treatment
- Allergy to study drugs
- Severe untreated disease or organ failure
- Presence of a pacemaker
- Emergency surgery
- Patient refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgical procedure day
Participants undergo surgery during which they may receive intraoperative non-invasive analgesia monitoring and/or intravenous lidocaine infusion as per group assignment.
1 visit (in-person, day of surgery)
Duration - 24 hours post-surgery
Participants are monitored for postoperative pain scores, opioid use, and any adverse events related to lidocaine or opioids during the first 24 hours after surgery.
1 visit (in-person or remote within 24 hours post-surgery)
Trial Site Locations
Total: 1 location
1
Regional Gastroenterology and Hepatology Institute Octavian Fodor
Cluj-Napoca, Cluj, Romania
Actively Recruiting
Research Team
C
Cristiana Osoian
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here