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

Completed

• Conditions: Anesthesia

• Registration Number: NCT01839513
• Lead Sponsor: Hôpital Edouard Herriot

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-04-22
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-25
• Study Start: 2013-05
• Primary Completion: 2013-10
• Status Verified: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-01
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in heart rate and/or systolic blood pressure by more than 20% within 5 minutes	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)

Trial Locations

Locations (1)

Hôpital Édouard Herriot, HCL; 🇫🇷 Lyon, Rhône, France