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Completed

NCT Number: NCT01839513

Prediction of Hemodynamic Reactivity During 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Édouard Herriot, HCL

Lyon, Rhône, 69003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Hôpital Edouard Herriot

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 25, 2013
Registry last updated
Nov 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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