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Completed

NCT Number: NCT01483547

Reliability of BIS Monitoring in Neurosurgical Patients

The aim of the study is to assess the reliability of Bispectral Index (BIS Vista , Covidien) in neurosurgical patients . BIS values at Loss of Consciousness (LOC), Post Intubation (PI) and Return of Consciousness (ROC) in neurosurgical patients are compared to those of non-neurosurgical patients, during routine anesthesia procedures.

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Key information

Conditions

Sovra and Intra Tentorial Lesions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Neurologico Carlo Besta

Milan, 20133, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BIS > 90 at baseline (awake)
  • ASA I or II

Exclusion criteria

  • GSC < 15
  • anticipated difficult ventilation and/or intubation
  • BMI > 30
  • surgical site that does not allow BIS monitoring
  • bilateral hearing loss
  • not speaking Italian Language

Treatment and study plan

Bispectral Index (BIS Vista, Covidien)

Device

BIS values at LOC, PI, ROC.

Primary outcomes

  1. BIS values at LOC, PI and ROC

    Time frame: 8 months

Secondary outcomes

  1. incidence of intraoperative awareness

    Time frame: 0, 1, 3, 30 days after surgery

    intraoperative awareness assessed by BRICE Interview

  2. incidence of postoperative delirium

    Time frame: 0, 1, 3, 30 days after surgery

    assessed by Nursing Delirium Scale and CAM-ICU.

  3. predicted site effect drugs concentration at LOC, PI and ROC

    Time frame: 8 months

    Propofol and Remifentanil site effect concentrations delivered by TCI.

  4. total amount of anesthetic drugs delivered at the end of surgery

    Time frame: 8 months

  5. recovery time after surgery

    Time frame: 8 months

    Time needed for the patients to completely regain orientation

Sponsors and collaborators

Lead sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Other

Registry information

Official study title

Reliability of Bispectral Index for Depth of Anesthesia Monitoring in Neurosurgical Patients

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 1, 2011
Registry last updated
Feb 18, 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.