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Completed

NCT Number: NCT02240368

Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery

The purpose of this study is to determine how Bispectral index (BIS) and Entropy EEG monitors agree between themselves and with end-tidal concentration of sevoflurane (ETsevo) in relationship with the age in the pediatric surgery setting.

Bispectral index (BIS) and Entropy EEG monitors performance and utility is well established in adult general anesthesia.

Their utility is yet undefined in the pediatric population as age seems to affect their ability to track the cerebral hypnotic state in children.

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Key information

Conditions

Anesthesia Child

Age range

1 month–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedali Riuniti

Foggia, FG, 70100, Italy

About this study

All patients monitored applying standard device for blood pressure, electrocardiogram and pulse oximeter for routine monitor of anesthesia in pediatric surgery. Bispectral VISTA monitor and Entropy monitor applied for monitoring the depth of anesthesia. The investigators will not assign any specific interventions to the subjects of the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • physical status classification (ASA) I - II
  • general balanced anesthesia
  • mechanically ventilated with laryngeal mask

Exclusion criteria

  • severe developmental delay
  • neurological disorders or receiving treatment with antiepileptic or stimulant
  • patients with preexisting lung or cardiac disease
  • airway abnormalities
  • marked skin sensitivity and conditions where the placement of the BIS and Entropy sensor or process of assessment would interfere with the surgery procedure.
  • patients receiving local anaesthesia, regional block combined with general anaesthesia
  • sedation administered by non anesthesiologists for invasive and noninvasive diagnostic or therapeutic procedures

Treatment and study plan

Primary outcomes

  1. BISPECTRAL Index

    Time frame: BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours

    The collected values of bispectral index and end tidal sevofluorane will generate a single prediction probability (PK) of agreement between bispectral index vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.

    Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.

  2. Entropy

    Time frame: Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours

    The collected values of Entropy will generate a single prediction probability (PK) of agreement between Entropy vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.

    Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.

Secondary outcomes

  1. BISPECTRAL Index Awaking

    Time frame: reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia

    In each patient the Bispectral index values at the moment of first signs of awakening.The Bispectral index monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer

  2. Entropy Awaking

    Time frame: reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia

    In each patient the Entropy values at the moment of first signs of awakening. The Entropy monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A Entropy value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer

Sponsors and collaborators

Lead sponsor

University of Foggia

Other

Collaborators

  • University College, London

Registry information

Official study title

Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery. Bispectral VISTA and ENTROPY Monitor for Pediatric Anesthesia.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 15, 2014
Registry last updated
Aug 14, 2018

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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