ClinicalTrials.Veeva

Menu

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

U

University Hospital Schleswig-Holstein (UKSH)

Status

Unknown

Conditions

General Anaesthesia

Treatments

Procedure: tetanic stimulation

Study type

Observational

Funder types

Other

Identifiers

NCT01522508
ANI-134-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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 -

Trial design

50 participants in 2 patient groups

propofol/remifentanil
Description:
patients receive standardized propofol and changing remifentanil concentrations
Treatment:
Procedure: tetanic stimulation
sevoflurane/remifentanil
Description:
patients receive standardized sevoflurane and changing remifentanil concentrations
Treatment:
Procedure: tetanic stimulation

Trial contacts and locations

1

Loading...

Central trial contact

Matthias Gruenewald, MD; Berthold Bein, MD, PhD, DEAA

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems