EEG Monitoring to Assess Emergence From Neuroanesthesia

NCT00443807 | Completed

• 1 other identifier: B2007:008
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

A highly desired result in neuroanesthesia is a prompt, controlled emergence following a neurosurgical procedure. Considerable strides have been made in this direction with volatile anesthetic agents such as sevoflurane or desflurane administered in association with the narcotic remifentanil. It is characteristic that patients will emerge within 5 to 10 minutes of cessation of these agents at the end of a neuroanesthetic. However, there are cases where emergence is delayed, especially after periods of deep anesthesia for i) cerebral protection with temporary clipping of cerebral aneurysms and ii) with microvascular decompression for trigeminal neuralgia. Deep levels of anesthesia are standard for these procedures in the posterior fossa, which utilize motor evoked potentials to assess cranial nerve function. In these cases, EEG monitoring is standard. Using the EEG to monitor emergence to aid its progress makes sense. A monitor which could predict emergence in these patients would be valuable. EEG monitoring engineered to provide this information is now available in the form of the EEGo. This study is designed to test the hypothesis that the EEGo monitor will be superior to the BIS monitor to assess emergence following neuroanesthesia.

Conditions

Cerebral Aneurysm; Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (1)

• An assessment of quality of emergence - smooth, single cough, multiple coughs will be provided by the neurosurgeon

  Wake up time in OR

Secondary Outcomes (1)

• Twenty-four hours post surgery a directed survey of patient satisfaction and questioning regarding awareness will be done

  hours

Interventions

On-line EEG monitoring during neurosurgery DEVICE

Comparison of 2 ways of processing the EEG signal

Also known as: EEGo, BIS Vista

EEGo vs BIS DEVICE

comparison of two processed EEG monitors.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients undergoing neurosurgery where intraoperative EEG monitoring is the standard of care will be approached in the Pre-Anesthetic Clinic for participation.

You may not qualify if:

• Patient refusal
• a history of asthma requiring routine use of bronchodilators, because the study will use desflurane as the volatile agent
• pregnancy
• non-elective aneurysm clipping

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

MeSH Terms

Conditions

Intracranial Aneurysm; Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases

Study Officials

• W. Alan C. Mutch, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2007
• First Posted: March 6, 2007
• Study Start: August 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 16, 2008

Record last verified: 2008-04

Locations

CA (1)