Prediction of Hemodynamic Reactivity During General Anesthesia Using Analgesia/Nociception Index (ANI)

November 1, 2013 updated by: Emmanuel Boselli, Hôpital Edouard Herriot

Prediction of Hemodynamic Reactivity During Desflurane/Remifentanil General Anesthesia Using Analgesia/Nociception Index (ANI)

The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the prediction of hemodynamic reactivity in adult patients undergoing ear-nose-throat or lower limb orthopedic surgery on desflurane/remifentanil 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)

100

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 ear-nose-throat or orthopedic lower limb surgery performed on desflurane/remifentanil general anesthesia

Description

Inclusion Criteria:

  • Age 18-75 years
  • Ear-nose-throat or lower limb surgery
  • General anesthesia using desflurane and remifentanil

Exclusion Criteria:

  • Age <18 yrs or >75 yrs
  • Arrythmia
  • Preoperative use of B-blockers
  • 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 incision, at steady-state anesthesia during procedure (an expected average of 30 min) and at arousal from general anesthesia in the end of procedure (an expected average of 60 min)
Before induction of anesthesia, 1 min after incision, at steady-state anesthesia during procedure (an expected average of 30 min) and at arousal from general anesthesia in the end of procedure (an expected average of 60 min)

Collaborators and Investigators

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

Sponsor

Hôpital Edouard Herriot

Investigators

  • Study Director: Emmanuel Boselli, MD, PhD, Hopital Edourd Herriot
  • Study Chair: Bernard Allaouchiche, MD, PhD, Hôpital Edouard Herriot

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 5, 2013

Last Update Submitted That Met QC Criteria

November 1, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CPP 2013-021B

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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