Depth of Anesthesia (DOA)NCT02088671

Effectiveness of the NeuroSENSE for Monitoring the Hypnotic Depth of Anesthesia

An observational study of Depth of Anesthesia (DOA), run by NeuroWave Systems Inc. at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this clinical study is to investigate whether the NeuroSENSE is an adequate monitor of hypnotic depth-of-anesthesia (DOA). Therefore, this study will investigate whether the information provided by the NeuroSENSE Monitor can help in assessing the hypnotic effect of anesthetics in adult patients… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Depth of Anesthesia (DOA)
What is being tested?: Propofol induction followed by randomized doses of desflurane, Recording of EEG using NeuroSENSE and Data collection
Type of treatment: Injection or infusion, Medical device
How many people: 76 participants
Where: 2 sitesCanada
Study dates: Jun 2014to Oct 2016
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult patients undergoing general anesthesia procedure in the context of either open or laparoscopic abdominal surgical procedures (e.g. colectomy, hysterectomy, radical retropubic prostatectomy, nephrectomy, pancreatectomy, etc.), breast surgery including reduction, reconstruction and mastectomies, or orthopedic surgeries under general anesthesia, expected to last at least 1 hour.

Who may be able to join

age 18-75 years
ASA (American Society of Anesthesiologist) physical status I, II, or III
ability to read and understand the informed consent form
undergoing anesthesia procedure requiring intubation
scheduled to undergo either open or laparoscopic abdominal surgical procedures (e.g. colectomy, hysterectomy, radical retropubic prostatectomy, nephrectomy, pancreatectomy, etc.), breast surgery including reduction, reconstruction and mastectomies, or orthopedic surgeries under general anesthesia, expected to last at least 1 hour.

Who cannot join

history of major head injury (possible abnormal EEG)
acquired scalp or skull abnormalities (e.g. psoriasis, eczema, angioma, scar tissue, burr holes, cranial implants)
evidence of recent trauma or active neurological disorder, stroke, seizure disorder, intellectual disability, dementia or diagnosis of Alzheimer's disease
major antipsychotic medications taken within last 7 days (eg. Lithium, risperidone, olanzapine)
known history of alcohol or drug abuse within last 30 days
body mass index (weight in kilograms divided by square of height in meters) > 40.0 kg/m2

Show all 12Show fewer

uncontrolled hypertension with blood pressure recorded prior to surgery (systolic blood pressure > 200 mmHg or diastolic blood pressure > 110 mmHg)
systolic blood pressure < 90 mmHg, recorded prior to surgery
heart rate (HR) < 45 beats/min, recorded prior to surgery
insulin-dependent diabetes mellitus
pregnancy
any serious medical condition that would interfere with cardiovascular response assessment or study results interpretation

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

Fraser Health: Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
Fraser Health: Eagle Ridge Hospital
Port Moody, British Columbia, V3H 3W9

Other trials in Canada

About this study

Official title: A Prospective, Blinded, Clinical Study for Assessing the Effectiveness of the NeuroSENSE for Monitoring the Hypnotic Depth of Anesthesia (DOA)

Read the detailed description

In particular, the study will focus on the correlation between the WAVcns index, a proprietary quantifier of cortical activity displayed by the NeuroSENSE, with (1) commonly assessed clinical endpoints/variables relating to the DOA, (2) changes in anesthetic drug administration, and (3) the anesthesiologist's assessment of the DOA based on standard of care monitors and his/her own observations of the patient state.

The hypothesis under evaluation is that the WAVcns index is an independent assessor of the progression of the anesthetic state and events of general anesthesia related to hypnotic endpoints.

Conditions: Depth of Anesthesia (DOA)
Being tested: Propofol induction followed by randomized doses of desflurane, Recording of EEG using NeuroSENSE, Data collection, Drug: Emergence by stepping down the desflurane ET
Keywords: NeuroSENSE, Anesthesia, Hypnosis, Desflurane, Propofol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Propofol induction followed by randomized doses of desfluraneDrug
Also called Suprane, Diprivan
Anesthesia in all patients will be induced with iv propofol 1.5 mg/kg with extra 0.5 mg/kg doses as needed. Anesthesia will be maintained using inhaled desflurane in oxygen/air with the initial desflurane concentration of 1.2 MAC, which will be changed in steps of ±0.4 MAC after reaching the post-intubation steady state. The step changes will be initiated every 7.5 min, as follows: at every level of MAC there is a 1/3 chance in remaining at this level and a 2/3 chance of changing it. The anesthesiologist can accept the change to move to the new level. However, he/she can also reject it to remain at the current level for another 7.5 min. This scheme yields 3 possible desflurane levels: 0.8, 1.2 and 1.6 MAC. The anesthesiologist can also leave the randomization schedule at anytime if clinically indicated, and later re-start it at his/her discretion. All anesthetic doses and their changes fall within conventional dosing.
Recording of EEG using NeuroSENSEDevice
Also called NeuroSENSE Monitoring System, Model NS-701 (approved in Canada and European market (CE Mark)), NeuroFAST Monitoring System, Model NF-202 (US name, the device is not cleared by the FDA)
The NeuroSENSE NS-701 system is a 2-channel device for brain activity monitoring in the operating room, intensive care unit, emergency room and other clinical settings. The system acquires and processes electroencephalograms (EEGs) via noninvasive electrodes placed on a patient's forehead. The acquired raw EEG signals and processed EEG variables are continuously displayed for interpretation by the clinician.
The proprietary processed variable, WAVcns, quantifies the patient's brain activity, which is typically affected by anesthetic drugs. The system displays processed variables based on 2 bilateral channels (1 per brain hemisphere) for use as a supplement to the anesthesia standard of care.
Note: the indications provided by the NeuroSENSE monitor are not used for anesthesia dosing or patient assessment in this study, and the anesthesia provider is blinded to the monitor readings. The device is used only for acquisition of EEG signals and may be used to log the events of interest.
Data collectionOther
Non-invasive blood pressure (BP), heart rate (HR), respiratory rate (RR) and electroencephalogram (EEG) will be recorded during the surgery in all subjects. Also, information about all medically significant events, all study-related events (incl. patient's reactions, responses, observations and assessments) and administered medications (incl. end-tidal (ET) desflurane concentration) will be recorded along with time stamps.
The anesthesia and physiological parameters (e.g., BP, HR, RR, ET agent concentration) outputted from the anesthesia monitor will be recorded electronically during the surgery by the anesthesia monitoring system (data-points will be recorded at least every 3 min for BP and every 10 sec for other variables).
The EEG signal will be continuously recorded by NeuroSENSE NS-701 Monitor (described under a separate intervention).
The CRC will also be present in the Operating Room (OR) to record and manage the recording of all the required information.
Drug: Emergence by stepping down the desflurane ETOther
Also called Suprane
Anesthesia will be reduced to facilitate rapid recovery at the discretion of the anesthesiologist, about 20 minutes before the end of surgery. The desflurane ET will be stepped down from 0.8 MAC by steps of 0.2 MAC approximately every 5 min during the Emergence.

Study groups in NCT02088671
Study group	Role	What they receive
Anesthesia		A single study group undergoing general anesthesia procedure to observe post-hoc the effect on the NeuroSENSE monitor readings. Interventions of interest: Drug: Propofol induction followed by randomized doses of desflurane; Emergence by stepping down the desflurane ET - See intervention descriptions. Device: Recording of EEG using NeuroSENSE (blinded to clinicians) - See intervention descriptions. Other: Data Collection - See intervention descriptions Receives: Drug: Propofol induction followed by randomized doses of desflurane; Device: Recording of EEG using NeuroSENSE; Other: Data collection; Other: Drug: Emergence by stepping down the desflurane ET

What is being measured

The primary outcome is the main question the study is designed to answer.

Prediction probability Pk for the WAVcns for consciousness vs unconsciousness
The primary outcome will test the performance of WAVcns index in discriminating between consciousness and unconsciousness during induction of anesthesia. It will be evaluated using Receiver-Operating Characteristic (ROC), and Area Under Curve (AUC) will be calculated. Note that the AUC statistic is equal to the prediction probability Pk for dichotomous responses, such as consciousness and unconsciousness.
Measured: During induction of anesthesia, an expected average of 4 min

Secondary outcomes (3)

Prediction probability Pk for the WAVcns for responders vs nonresponders to lidocaine aerosol
This secondary outcome will test if the WAVcns index prior to lidocaine insufflations or intubation is a good predictor of patient response. The aerosolized lidocaine will be used as a standardized stimulus to objectively assess response observed at the larynx and seen in the patient during airway manipulation during induction of anesthesia.
Measured: During induction of anesthesia, an expected average of 4 min
Correlation of the WAVcns with primary anesthetic dosing
This secondary outcome will test if the WAVcns index during anesthesia maintenance correlates with primary anesthetic dosing (end tidal agent concentration).
Measured: During anesthesia maintenance, an expected average of 2 hrs
Prediction probability for the WAVcns for responders vs nonresponders to verbal command
This secondary outcome will test if the WAVcns index accurately indicates return of consciousness (response to verbal command) during emergence.
Measured: During emergence from anesthesia, an expected average of 20 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Oct 2016

First posted17 Mar 2014 (estimated)
Study startJun 2014
Primary completionDec 2014
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Depth of Anesthesia (DOA)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02088671
Sponsor's protocol ID: 925-0701-DCI
Other IDs: W81XWH-06-C-0016
Status last verified: Feb 2020
First submitted: 12 Mar 2014
Last updated: 25 Feb 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Gorges M, West NC, Cooke EM, Pi S, Brant RF, Dumont GA, Ansermino JM, Merchant RN. Evaluating NeuroSENSE for assessing depth of hypnosis during desflurane anesthesia: an adaptive, randomized-controlled trial. Can J Anaesth. 2020 Mar;67(3):324-335. doi: 10.1007/s12630-019-01522-5. Epub 2019 Nov 5.
PubMed 31691253

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Blinded, Clinical Study for Assessing the Effectiveness of the NeuroSENSE for Monitoring the Hypnotic Depth of Anesthesia (DOA)
ClinicalTrials.gov ID: NCT02088671
Acronym / sponsor ID: 925-0701-DCI
Conditions: Depth of Anesthesia (DOA)
Keywords: NeuroSENSE, Anesthesia, Hypnosis, Desflurane, Propofol
Study type: Observational
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: NeuroWave Systems Inc.Industry (pharma, biotech, devices)
Collaborators: U.S. Army Medical Research Acquisition Activity, Fraser Health
Study start: Jun 2014
Primary completion: Dec 2014 (actual)
Study completion: Oct 2016 (actual)
First posted: 17 Mar 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The hypothesis under evaluation is that the WAVcns index is an independent assessor of the progression of the anesthetic state and events of general anesthesia related to hypnotic endpoints.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Anesthesia	–	Drug: Propofol induction followed by randomized doses of desflurane, Device: Recording of EEG using NeuroSENSE, Other: Data collection, Other: Drug: Emergence by stepping down the desflurane ETA single study group undergoing general anesthesia procedure to observe post-hoc the effect on the NeuroSENSE monitor readings. Interventions of interest: Drug: Propofol induction followed by randomized doses of desflurane; Emergence by stepping down the desflurane ET - See intervention descriptions. Device: Recording of EEG using NeuroSENSE (blinded to clinicians) - See intervention descriptions. Other: Data Collection - See intervention descriptions

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult patients undergoing general anesthesia procedure in the context of either open or laparoscopic abdominal surgical procedures (e.g. colectomy, hysterectomy, radical retropubic prostatectomy, nephrectomy, pancreatectomy, etc.), breast surgery including reduction, reconstruction and mastectomies, or orthopedic surgeries under general anesthesia, expected to last at least 1 hour.

Key inclusion criteria (5 listed)

age 18-75 years
ASA (American Society of Anesthesiologist) physical status I, II, or III
ability to read and understand the informed consent form
undergoing anesthesia procedure requiring intubation
scheduled to undergo either open or laparoscopic abdominal surgical procedures (e.g. colectomy, hysterectomy, radical retropubic prostatectomy, nephrectomy, pancreatectomy, etc.), breast surgery including reduction, reconstruction and mastectomies, or orthopedic surgeries under general anesthesia, expected to last at least 1 hour.

Key exclusion criteria (12 listed)

history of major head injury (possible abnormal EEG)
acquired scalp or skull abnormalities (e.g. psoriasis, eczema, angioma, scar tissue, burr holes, cranial implants)
evidence of recent trauma or active neurological disorder, stroke, seizure disorder, intellectual disability, dementia or diagnosis of Alzheimer's disease
major antipsychotic medications taken within last 7 days (eg. Lithium, risperidone, olanzapine)
known history of alcohol or drug abuse within last 30 days

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Propofol induction followed by randomized doses of desfluraneAlso: Suprane, DiprivanAnesthesia in all patients will be induced with iv propofol 1.5 mg/kg with extra 0.5 mg/kg doses as needed. Anesthesia will be maintained using inhaled desflurane in oxygen/air with the initial desflurane concentration of 1.2 MAC, which will be changed in steps of ±0.4 MAC after reaching the post-intubation steady state. The step changes will be initiated every 7.5 min, as follows: at every level of MAC there is a 1/3 chance in remaining at this level and a 2/3 chance of changing it. The anesthesiologist can accept the change to move to the new level. However, he/she can also reject it to remain at the current level for another 7.5 min. This scheme yields 3 possible desflurane levels: 0.8, 1.2 and 1.6 MAC. The anesthesiologist can also leave the randomization schedule at anytime if clinically indicated, and later re-start it at his/her discretion. All anesthetic doses and their changes fall within conventional dosing.	Drug	Anesthesia
Recording of EEG using NeuroSENSEAlso: NeuroSENSE Monitoring System, Model NS-701 (approved in Canada and European market (CE Mark)), NeuroFAST Monitoring System, Model NF-202 (US name, the device is not cleared by the FDA)The NeuroSENSE NS-701 system is a 2-channel device for brain activity monitoring in the operating room, intensive care unit, emergency room and other clinical settings. The system acquires and processes electroencephalograms (EEGs) via noninvasive electrodes placed on a patient's forehead. The acquired raw EEG signals and processed EEG variables are continuously displayed for interpretation by the clinician. The proprietary processed variable, WAVcns, quantifies the patient's brain activity, which is typically affected by anesthetic drugs. The system displays processed variables based on 2 bilateral channels (1 per brain hemisphere) for use as a supplement to the anesthesia standard of care. Note: the indications provided by the NeuroSENSE monitor are not used for anesthesia dosing or patient assessment in this study, and the anesthesia provider is blinded to the monitor readings. The device is used only for acquisition of EEG signals and may be used to log the events of interest.	Device	Anesthesia
Data collectionNon-invasive blood pressure (BP), heart rate (HR), respiratory rate (RR) and electroencephalogram (EEG) will be recorded during the surgery in all subjects. Also, information about all medically significant events, all study-related events (incl. patient's reactions, responses, observations and assessments) and administered medications (incl. end-tidal (ET) desflurane concentration) will be recorded along with time stamps. The anesthesia and physiological parameters (e.g., BP, HR, RR, ET agent concentration) outputted from the anesthesia monitor will be recorded electronically during the surgery by the anesthesia monitoring system (data-points will be recorded at least every 3 min for BP and every 10 sec for other variables). The EEG signal will be continuously recorded by NeuroSENSE NS-701 Monitor (described under a separate intervention). The CRC will also be present in the Operating Room (OR) to record and manage the recording of all the required information.	Other	Anesthesia
Drug: Emergence by stepping down the desflurane ETAlso: SupraneAnesthesia will be reduced to facilitate rapid recovery at the discretion of the anesthesiologist, about 20 minutes before the end of surgery. The desflurane ET will be stepped down from 0.8 MAC by steps of 0.2 MAC approximately every 5 min during the Emergence.	Other	Anesthesia

Primary outcome

Prediction probability Pk for the WAVcns for consciousness vs unconsciousness
Time frame: During induction of anesthesia, an expected average of 4 min
The primary outcome will test the performance of WAVcns index in discriminating between consciousness and unconsciousness during induction of anesthesia. It will be evaluated using Receiver-Operating Characteristic (ROC), and Area Under Curve (AUC) will be calculated. Note that the AUC statistic is equal to the prediction probability Pk for dichotomous responses, such as consciousness and unconsciousness.

3 secondary outcomes

Prediction probability Pk for the WAVcns for responders vs nonresponders to lidocaine aerosol
Time frame: During induction of anesthesia, an expected average of 4 min
Correlation of the WAVcns with primary anesthetic dosing
Time frame: During anesthesia maintenance, an expected average of 2 hrs
Prediction probability for the WAVcns for responders vs nonresponders to verbal command
Time frame: During emergence from anesthesia, an expected average of 20 min

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
Results publication: PubMed 31691253Gorges M, West NC, Cooke EM, Pi S, Brant RF, Dumont GA, Ansermino JM, Merchant RN. Evaluating NeuroSENSE for assessing depth of hypnosis during desflurane anesthesia: an adaptive, randomized-controlled trial. Can J Anaesth. 2020 Mar;67(3):324-335. doi: 10.1007/s12630-019-01522-5. Epub 2019 Nov 5.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard Merchant, MD FRCPC principal investigator

Fraser Health

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Depth of Anesthesia (DOA), run by NeuroWave Systems Inc. at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prediction probability Pk for the WAVcns for consciousness vs unconsciousness (time frame: During induction of anesthesia, an expected average of 4 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02088671, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.