Pain Clinical Trial - Evaluating the Predictive Value of the Nociception

Status Completed

Clinical Trial Summary

Opioids remain the cornerstone for perioperative analgesia, albeit frequently associated with side effects. Most of these side-effects are dose-dependent. Thus intra-operative monitors are necessary to measure the balance between Nociception and Anti-Nociception (NAN balance) by an adequate opioid administration. Recently the NOL monitor was released.The NoL index ranges from 0 to 100 and is based on a nonlinear combination of nociception-related physiologic variables, specifically heart rate (HR), heart rate variability at the 0.15- to 0.4-Hz band power, photoplethysmograph wave amplitude (PPGA), skin conductance level, number of skin conductance fluctuations, and their time derivatives. The NoL index estimates the nociceptive/antinociceptive state from these component measures using random forest regression. In our department, a combination of TCI propofol (Schnider model) and remifentanil (Minto model) is used to for most of the anaesthetic procedures, including cardiac anaesthesia. Remifentanil is titrated to prevent an increase in blood pressure and hearth rhythm at noxious stimuli, such as surgical incision, and adapted following hemodynamic trend during surgery. The hypothesis of this study is to develop a calibration test using the NOL index variation to define the individual most appropriate NAN balance using remifentanil TCI before the start of surgery and before a very strong noxious surgical stimulus such as surgical incision in non-cardiac and cardiac surgery. Before the start of surgery, the investigators want to titrate in each patient the remifentanil Ce required to abolish the NOL index response to a calibrated noxious tetanic stimulus (Tetanus 60 mamp, 100 Hz, 30 seconds). Thus this individual remifentanil Ce will be the remifentanil level programmed before surgical incision. NOL and hemodynamic responses will be recorded during the entire duration of surgery. Study protocol amendment: validation of the calibration study: Data from the calibration phase will be used to derive a formula to predict individualised anti-nociception for incision.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03324269
Study type	Interventional
Source	Université Libre de Bruxelles
Contact
Status	Completed
Phase	N/A
Start date	October 1, 2017
Completion date	February 28, 2019

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05559255` - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI	N/A
Completed	`NCT04748367` - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care	N/A
Terminated	`NCT04356352` - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain	Phase 2/Phase 3
Completed	`NCT05057988` - Virtual Empowered Relief for Chronic Pain	N/A
Completed	`NCT04466111` - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting	`NCT06206252` - Can Medical Cannabis Affect Opioid Use?
Completed	`NCT05868122` - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy	Phase 3
Active, not recruiting	`NCT05006976` - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study	N/A
Completed	`NCT03273114` - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain	N/A
Enrolling by invitation	`NCT06087432` - Is PNF Application Effective on Temporomandibular Dysfunction	N/A
Completed	`NCT05508594` - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001	Phase 2/Phase 3
Recruiting	`NCT03646955` - Partial Breast Versus no Irradiation for Women With Early Breast Cancer	N/A
Active, not recruiting	`NCT03472300` - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed	`NCT03678168` - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries	N/A
Completed	`NCT03931772` - Online Automated Self-Hypnosis Program	N/A
Completed	`NCT03286543` - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System	N/A
Completed	`NCT02913027` - Can We Improve the Comfort of Pelvic Exams?	N/A
Terminated	`NCT02181387` - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?	Phase 4
Recruiting	`NCT06032559` - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment	Phase 3
Active, not recruiting	`NCT03613155` - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluating the Predictive Value of the Nociception Level Index NOL

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms