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Observational Evaluation of the Last Version of the PMD200TM

NCT02884778 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-01-16

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Detection of pain after nociceptive stimulus

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

Sponsors & Collaborators

  • Medasense Biometrics Ltd

    collaborator OTHER

  • Maisonneuve-Rosemont Hospital

    lead OTHER

Principal Investigators

  • Philippe Richebe, MD PhD · Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal, University of Montreal

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-11-30
Completion
2016-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02884778 on ClinicalTrials.gov