Clinical trial NCT02088671: Effectiveness of the NeuroSENSE for Monitoring the Hypnotic Depth of Anesthesia
Official title: A Prospective, Blinded, Clinical Study for Assessing the Effectiveness of the NeuroSENSE for Monitoring the Hypnotic Depth of Anesthesia (DOA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depth of Anesthesia (DOA)
Keywords: NeuroSENSE
Anesthesia
Hypnosis
Desflurane
Propofol
Lead sponsor: NeuroWave Systems Inc.
Sponsor class: INDUSTRY
Collaborators: name: U.S. Army Medical Research Acquisition Activity
name: Fraser Health
First posted: 2014-03-17
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 undergoing general anesthesia.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Prediction probability Pk for the WAVcns for consciousness vs unconsciousness
timeFrame: During induction of anesthesia, an expected average of 4 min
Secondary outcomes:
measure: Prediction probability Pk for the WAVcns for responders vs nonresponders to lidocaine aerosol
timeFrame: During induction of anesthesia, an expected average of 4 min
measure: Correlation of the WAVcns with primary anesthetic dosing
timeFrame: During anesthesia maintenance, an expected average of 2 hrs
measure: Prediction probability for the WAVcns for responders vs nonresponders to verbal command
timeFrame: During emergence from anesthesia, an expected average of 20 min
Other outcomes:
measure: Correlation of the WAVcns with burst-suppression ratio
timeFrame: During maintenance of anesthesia, an expected average of 2 hrs
Locations:
city: New Westminster
country: Canada
facility: Fraser Health: Royal Columbian Hospital
state: British Columbia
city: Port Moody
country: Canada
facility: Fraser Health: Eagle Ridge Hospital
state: British Columbia
Study officials:
affiliation: Fraser Health
name: Richard Merchant, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.