Reliability of BIS Monitoring in Neurosurgical Patients

Sovra and Intra Tentorial Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483547
• Other study ID #: BISnch2011
• Status: Completed
• Phase: N/A
• First received: November 25, 2011
• Last updated: February 15, 2013
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sovra and Intra Tentorial Lesions

Intervention

Device:
• Bispectral Index (BIS Vista, Covidien)
BIS values at LOC, PI, ROC.

Locations

Country	Name	City	State
Italy	Istituto Neurologico Carlo Besta	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BIS values at LOC, PI and ROC		8 months	No
Secondary	incidence of intraoperative awareness	intraoperative awareness assessed by BRICE Interview	0, 1, 3, 30 days after surgery	No
Secondary	incidence of postoperative delirium	assessed by Nursing Delirium Scale and CAM-ICU.	0, 1, 3, 30 days after surgery	No
Secondary	predicted site effect drugs concentration at LOC, PI and ROC	Propofol and Remifentanil site effect concentrations delivered by TCI.	8 months	No
Secondary	total amount of anesthetic drugs delivered at the end of surgery		8 months	No
Secondary	recovery time after surgery	Time needed for the patients to completely regain orientation	8 months	No