BIS and Entropy in Deep Brain Simulation

NCT02386995 | Completed Results DMC

• 1 other identifier: 13-6060
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to determine whether depth of anesthesia (DOA) monitoring such as Bispectral Index (BIS) and entropy are accurate in patients with neuro-psychological conditions such as Parkinson's disease by comparing these monitoring with standard clinical monitoring like heart rate, blood pressure and respiratory rate.

Conditions

Movement Disorders; Depth of Anesthesia Monitors

Keywords

depth of anesthesia monitors; deep brain stimulation

Outcome Measures

Primary Outcomes (1)

• Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices

  The trends of Bispectral (BIS) and Response entropy (RE) at different study time points. Bispectral (BIS) and Response entropy (RE) values range from 0 (absence of brain activity) to 100 (fully awake state). Values below 40 indicate deep anesthesia, values from 40 to 60 optimal and above 60 but below 90 inadequate anesthesia.

  One day

Study Arms (1)

BIS and Entropy monitoring

Depth of anesthesia monitoring (BIS and entropy) are compared with standard clinical monitoring in patients with deep brain stimulators inserted at internalization whilst they are having a general anesthesia.

Device: BIS monitor; Device: Entropy monitor

Interventions

BIS monitor DEVICE

Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia monitoring are then compared.

BIS and Entropy monitoring

Entropy monitor DEVICE

Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia

BIS and Entropy monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients having a general anesthesia post DBS insertion for the internalization of DBS.

You may qualify if:

• Adult patients older than 18 years of age scheduled for elective internalisation of DBS electrodes under general anesthesia.

You may not qualify if:

• lack of informed consent
• language barrier
• those that are transferred to an intensive care unit postoperatively.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Heath Network, Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Emad Al Azazi
• Organization: Toronto Western Hospital/UHN

emad.alazazi@uhnresearch.ca

416-603-8500

Study Officials

• Lashmi Venkatraghavan

  University Health Network, Toronto Western Hospital

  PRINCIPAL INVESTIGATOR

• Pirjo Manninen

  University Heath Network, Toronto Western Hospital

  PRINCIPAL INVESTIGATOR

• Audrey MY Tan

  University Heath Network, Toronto Western Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 28, 2013
• First Posted: March 12, 2015
• Study Start: July 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 22, 2022
• Results First Posted: December 24, 2020

Record last verified: 2022-12

Locations

CA (1)