Prediction of Hemodynamic Reactivity During Suspension Laryngoscopy Using Analgesia/Nociception Index (ANI)

June 6, 2013 updated by: Emmanuel Boselli

Prediction of Hemodynamic Reactivity During Suspension Laryngoscopy Using Analgesia/Nociception Index (ANI): an Observational Study

The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the prediction of hemodynamic reactivity in adult patients undergoing suspension laryngoscopy on general anesthesia.

Study Overview

Status

Completed

Conditions

Detailed Description

Measurement of analgesia/nociception index at different time points during procedure and assessment of analgesia/nociception index to predict hemodynamic reactivity by building receiver observer's characteristic curve.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Rhône
      • Lyon, Rhône, France, 69003
        • Hôpital Edouard Herriot, HCL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients underoing suspension laryngoscopy performed on general anesthesia

Description

Inclusion Criteria:

  • Age 18-75 years
  • Suspension laryngoscopy for diagnostic or therapeutic purposes
  • Total intravenous anesthesia using propofol and remifentanil

Exclusion Criteria:

  • age <18 yrs or >75 yrs
  • arrythmia
  • administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes
  • psychiatric diseases
  • autonomic nervous system disorders (epilepsy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in heart rate and/or systolic blood pressure by more than 20% within 5 minutes
Time Frame: Before induction of anesthesia, 1 min after beginning of procedure, at steady-state anesthesia during procedure (an expected average of 10 min) and at arousal from general anesthesia in the end of procedure (an expected average of 20 min)
Before induction of anesthesia, 1 min after beginning of procedure, at steady-state anesthesia during procedure (an expected average of 10 min) and at arousal from general anesthesia in the end of procedure (an expected average of 20 min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emmanuel Boselli

Investigators

  • Study Director: Emmanuel Boselli, MD, PhD, Hôpital Edouard Herriot, HCL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

February 18, 2013

First Submitted That Met QC Criteria

February 19, 2013

First Posted (Estimate)

February 21, 2013

Study Record Updates

Last Update Posted (Estimate)

June 10, 2013

Last Update Submitted That Met QC Criteria

June 6, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CPP 2012-046B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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