Evaluation of Analgesia Nociception Index (ANI) During Propofol/Remifentanil and Sevoflurane/Remifentanil Anesthesia

• Conditions: General Anaesthesia
• Interventions: Procedure: tetanic stimulation

• Registration Number: NCT01522508
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief Summary

The aim of this prospective randomized study was to evaluate the ability of the new Analgesia Nociception Index ANI, derived by heart rate variability, to detect painful stimulation during either propofol or sevoflurane anesthesia and changing remifentanil concentrations.

Detailed Description

Monitoring Antinociception during general anesthesia is still a big challenge in the field and has not become clinical routine yet. Recently, for the Surgical Pleth Index SPI a benefit for the patient in terms of reduction of remifentanil use, less unwanted effects and shorter recovery from anesthesia was reported. However, there are new variables like the ANI that are developed to measure antinociception during anesthesia.

In the present study the investigators want to evaluate, whether ANI detects a painful tetanic stimulus during general anesthesia using propofol or sevoflurane and different concentrations of remifentanil.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-01-26
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-01-31
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-14
• Last Update Posted: 2012-06-15
• Primary Completion: 2012-07
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• age between 18- 65 years,
• ASA physical status I or II,
• elective surgery in general anesthesia planned,
• written informed consent

Exclusion Criteria

• pregnancy,
• history of cardiac arrhythmia,
• presents of any neuromuscular or neurologic disease,
• use of CNS-active medication or abuse of alcohol/illicit drugs -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sevoflurane/remifentanil	tetanic stimulation	patients receive standardized sevoflurane and changing remifentanil concentrations
propofol/remifentanil	tetanic stimulation	patients receive standardized propofol and changing remifentanil concentrations

Trial Locations

Locations (1)

University Hospital Kiel, Dept. of Anesthesiology and Intensive Care Med.; 🇩🇪 Kiel, Germany