Evaluation of NoL Index and ANI After Nociceptive Stimulation at Different Infusion Rates of Remifentanil Infusion

NCT02602379 | Completed DMC

• 1 other identifier: HMR14090
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Contrary to "immobility" and, to a lesser extent, to the "hypnosis/unconsciousness" component of general anaesthesia, the monitoring of "analgesia" remains largely elusive, evaluated mainly through poorly sensitive and potentially undesirable changes in patients' vital signs. This has led the industry to pursue the development of various devices and indices based on other physiological parameters such as heart rate variability (HRV), electroencephalogram (EEG), skin conductance, to name only a few. To the best of the knowledge, none of these parameters on its own has shown sufficient capacity in detecting different degrees of pain/analgesia balance to gain wide clinical use. The purpose of this prospective observational study is to evaluate the response of a single-parameter index (the Analgesia Nociception Index \[ANI\]) and a multi-parameter index (the Nociception Level \[NoL\] Index) when patients under combined general anaesthesia/epidural anaesthesia for laparotomies are subjected to a standardized painful stimulus (a tetanic stimulation over the ulnar nerve at 70 mA, 100 Hz for 30 seconds) at different doses of remifentanil infusion at steady state (0,005 mcg/kg/min; 0,05 mcg/kg/min; 0,1 mcg/kg/min; 0,15 mcg/kg/min). With the painful stimulus held constant but the analgesia provided gradually increased, it is expected to characterize the response of these two indices to different levels of nociception/anti-nociception balance.

Conditions

Pain

Keywords

Pain; Monitoring; Analgesia Nociception Index; NoL; Nociception Level; Remifentanil

Outcome Measures

Primary Outcomes (1)

• Correlation between NoL index responses to electrical stimulus and the i.v. doses of remifentanil infusion given during anesthesia. The n of patients (40 in this study) is calculated on this primary outcome.

  The electrical stimulus will be applied on the forearm of the asleep patient at different doses of iv remifentanil (0.005mcg/kg/min to a maximum of 0.15 mcg/kg.min during anesthesia for abdominal surgery with active intraoperative epidural pain management). It will be evaluated whether or not exists a correlation between the doses of iv remifentanil and the responses of the Nol index after electrical stimulus.

  At time of surgery

Secondary Outcomes (5)

• NoL index changes after a standardized electrical stimulus at 4 different concentrations of iv remifentanil infusion

  At time of surgery

• ANI index changes after a standardized electrical stimulus at 4 different concentrations of iv remifentanil infusion

  At time of surgery

• Heart rate changes after a standardized electrical stimulus at 4 different concentrations of iv remifentanil infusion

  At time of surgery

• Mean Blood Pressure changes after a standardized electrical stimulus at 4 different concentrations of iv remifentanil infusion

  At time of surgery

• Sensitivity and specificity of NoL index, ANI index, Heart Rate and Mean blood Pressure in detecting a painful stimulus such as intubation as well as standardized electrical stimulus at remifentanil infusion of 0.005 msg/kg/min

  At time of surgery

Study Arms (1)

Tetanic stimulation

Single arm study. See Study description for a through description of the intervention.

Other: Tetanic stimulation

Interventions

Tetanic stimulation OTHER

Standard Tetanic stimulation will be used as the stimulus to evaluate responses of the intraoperative pain indexes (ANI and NoL) at different concentration of i.v. remifentanil during anesthesia.

Tetanic stimulation

Eligibility Criteria

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

Study Population

Patients scheduled for elective abdominal surgery by laparotomy (general surgery or gynaecological surgery) who will receive a thoracic epidural (around T9-T10/T10-T11) and general anesthesia.

You may qualify if:

• ASA status I, II or III
• Elective abdominal surgery with median laparotomy under general anaesthesia 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
• Unexpected difficult airway requesting excessive, possibly painful airway manipulations.
• Dural puncture during epidural catheter installation
• Failure of epidural analgesia
• Surgical unexpected complications requiring strong haemodynamic support (transfusions, vasopressors, inotropes)

Sponsors & Collaborators

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

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Philippe Richebé, M.D. PhD

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor of anesthesiology

Study Record Dates

• First Submitted: October 25, 2015
• First Posted: November 11, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

CA (1)