Observational Evaluation of the Last Version of the PMD200TM

NCT02884778 | Completed

• 1 other identifier: 15074
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Title: Evaluation of the last version of the PMD200TM and its NoL index in patients undergoing laparotomies with intraoperative epidural analgesia Objectives: Measure NoL Index changes after a standardized nociceptive electrical stimulus at various intravenous remifentanil infusion rates (0.005, 0.05, 0.1 mcg/kg/min) and also after clinical stimuli such as intubation. Study Design: Prospective observational study Subject Population: Adults scheduled to undergo elective abdominal surgery with laparotomy under general anesthesia and epidural analgesia Sample Size: 30 patients Study Duration: Starts April 2016 - Ends November 2016 Study Center: Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada Adverse Events: None expected

Conditions

Pain Monitor During Anesthesia

Keywords

pain; monitoring; anesthesia

Outcome Measures

Primary Outcomes (1)

• Correlation between NoL index absolute values after electrical stimulus and the doses of remifentanil infused at the time of the stimulation.

  Measure NoL Index peak value (in fact we will take an average of 7 values: the peak value and 3 values before and 3 values after the peak, time between values = 5sec) after a nociceptive electrical stimulus and evaluate the spearman correlation between NoL Values after stimulus and remifentanil doses. It is expected to see that when we increase the doses of remifentanil infusion we see a decrease in the NoL index response to the painful standardized electrical stimulus.

  Day of surgery during anesthesia

Secondary Outcomes (9)

• NoL index peak absolute value after painful stimulus: intubation, electrical stimulations, no pain period, end of surgery

  Day of surgery during anesthesia

• Heart Rate peak absolute value after painful stimulus: intubation and electrical stimulations, no pain period, end of surgery

  Day of surgery during anesthesia

• Mean Arterial Blood Pressure (MABP) peak absolute value after painful stimulus: intubation and electrical stimulations, no pain period, end of surgery

  Day of surgery during anesthesia

• BISpectral index peak absolute value after painful stimulus: intubation and electrical stimulations, no pain period, end of surgery

  Day of surgery during anesthesia

• Correlation between the NoL index values (ranging from 0 to 100) and i.v. remifentanil infusion rate at the time of the electrical stimulation

  Day of surgery intraoperative during anesthesia

Other Outcomes (1)

• Correlation between end of surgery NoL value at the time of wound dressing and postoperative NRS pain scores (0-10) in PACU

  Intraoperative day of surgery and day of surgery in PACU

Study Arms (1)

NoL index in response to stimulation

EXPERIMENTAL

There is only one arm in this study. The "intervention" is not a drug, but it is the stimulus applied to the patient such as intubation and a standardized electrical stimulus applied on the forearm of the anesthetized patient. There are several stimuli that are the so-called "interventions" and the NoL index and the classical vital signs (heart rate, mean blood pressure, BISspectral index) are registered in response to these stimuli in an observational manner.

Diagnostic Test: Detection of pain after nociceptive stimulus

Interventions

Detection of pain after nociceptive stimulus DIAGNOSTIC_TEST

We will evaluate the changes of the NoL index absolute values after different types of stimulations such as intubation and electrical tetanic stimulation of the forearm (applied with the standard muscle relaxation monitor) in a patient under general anesthesia + epidural anesthesia for abdominal surgery

NoL index in response to stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA status I, II or III
• Age 18 years or older
• Elective abdominal surgery with median laparotomy under general anesthesia and epidural analgesia.

You may not qualify if:

• Coronary artery disease
• Serious cardiac arrhythmias (including atrial fibrillation)
• Patient refusal
• History of substance abuse
• Chronic use of psychotropic and/or opioid drugs
• Use of drugs that act on the autonomic nervous system (including β-blockers)
• History of psychiatric diseases or psychological problems
• Contraindications to epidural analgesia
• Allergy to remifentanil

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead
• Medasense Biometrics Ltd: collaborator

Study Sites (1)

Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal

Montreal, Quebec, H1T2M4, Canada

Location

Related Publications (1)

• Renaud-Roy E, Stockle PA, Maximos S, Brulotte V, Sideris L, Dube P, Drolet P, Tanoubi I, Issa R, Verdonck O, Fortier LP, Richebe P. Correlation between incremental remifentanil doses and the Nociception Level (NOL) index response after intraoperative noxious stimuli. Can J Anaesth. 2019 Sep;66(9):1049-1061. doi: 10.1007/s12630-019-01372-1. Epub 2019 Apr 17.

  PMID: 30997633 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe Richebe, MD PhD

  Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal, University of Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Full Professor, Director of Research of the Department of Anesthesiology

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: August 31, 2016
• Study Start: April 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 16, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)