Trial Outcomes & Findings for BIS and Entropy in Deep Brain Simulation (NCT NCT02386995)

Last Updated: 2022-12-22

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

One day

Results posted on

2022-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	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. BIS monitor: 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. Entropy monitor: 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
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BIS and Entropy Monitoring n=30 Participants 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. BIS monitor: 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. Entropy monitor: 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
Age, Customized Age	58.4 years STANDARD_DEVIATION 11 • n=30 Participants
Sex: Female, Male Female	12 Participants n=30 Participants
Sex: Female, Male Male	18 Participants n=30 Participants

PRIMARY outcome

Timeframe: One day

Population: Correlation analysis between BIS and RE from pre-induction time (T1) until the surgical closure time (T9) 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.

Outcome measures

Outcome measures
Measure	Bispectral Index BIS n=30 Participants The trends of Bispectral index (BIS) at different study time points (T)	Response Entropy Index n=30 Participants The trends of Response Entropy index (RE) at different study time points (T)
Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices T1 Awake (preinduction)	96 units on a scale Standard Deviation 1	96 units on a scale Standard Deviation 3
Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices T2 Loss of response to speech	65 units on a scale Standard Deviation 4	77 units on a scale Standard Deviation 9
Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices T3 Loss of eyelash reflex	59 units on a scale Standard Deviation 5	63 units on a scale Standard Deviation 6
Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices T4 Intubation	44 units on a scale Standard Deviation 4	53 units on a scale Standard Deviation 5
Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices T5 Knife to skin	44 units on a scale Standard Deviation 2	44 units on a scale Standard Deviation 5
Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices T6 Maintenance (prior to tunneling)	40 units on a scale Standard Deviation 4	33 units on a scale Standard Deviation 4
Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices T7 Tunneling in the neck	36 units on a scale Standard Deviation 6	32 units on a scale Standard Deviation 5
Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices T8 Start of skin closure	40 units on a scale Standard Deviation 6	37 units on a scale Standard Deviation 6
Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices T9 End of skin closure	42 units on a scale Standard Deviation 8	49 units on a scale Standard Deviation 9
Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices T10 Anaesthetic agent turned off	66 units on a scale Standard Deviation 7	59 units on a scale Standard Deviation 6
Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices T11 Obeying commands	87 units on a scale Standard Deviation 3	89 units on a scale Standard Deviation 6
Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices T12 Extubation	92 units on a scale Standard Deviation 3	93 units on a scale Standard Deviation 4
Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices T13 Post-extubation	93 units on a scale Standard Deviation 3	96 units on a scale Standard Deviation 2

Adverse Events

BIS and Entropy Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Emad Al Azazi

Toronto Western Hospital/UHN

Phone: 416-603-8500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place