Effectiveness of the NeuroSENSE for Monitoring the Hypnotic Depth of Anesthesia

NeuroWave Systems

Status: Completed

Conditions: Depth of Anesthesia (DOA)

Treatments: Device: Recording of EEG using NeuroSENSE; Drug: Propofol induction followed by randomized doses of desflurane; Other: Data collection; Other: Drug: Emergence by stepping down the desflurane ET

Study type: Observational

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT02088671

W81XWH-06-C-0016 (Other Grant/Funding Number)

925-0701-DCI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

76 participants in 1 patient group

Anesthesia

Description:

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

Treatment:

Other: Drug: Emergence by stepping down the desflurane ET

Other: Data collection

Device: Recording of EEG using NeuroSENSE

Drug: Propofol induction followed by randomized doses of desflurane