Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective, Randomized, Controlled Trial Comparing Bispectral Index Monitoring to Electronic Alerts for Prevention of Awareness During Anesthesia in the General Population
Brief Summary: Awareness during anesthesia is a problem receiving increased attention by patients, clinicians, and the general public. The incidence of intraoperative awareness has been reported to be between 1-2/1000 cases, but recent data suggest that this may be an overestimate. The Bispectral Index (BIS) Monitor is an electroencephalographic method of assessing depth of anesthesia that has been shown in one study to reduce the incidence of awareness during anesthesia in the high-risk population (Myles et al, 2004). In the study of Myles et al, the number needed to treat (NNT) in order to prevent one case of awareness in the high-risk population was 138, with an associated cost of approximately US$2200. Since the NNT and the associated cost of treatment would be much higher in the general population, the efficacy of the BIS monitor in preventing awareness in all anesthetized patients needs to be clearly established. Furthermore, recent data suggest that the BIS may not be useful in the high-risk population. The investigators propose a prospective, randomized, controlled trial comparing the BIS monitor to electronic alerts based on non-electroencephalographic gauges of anesthetic depth.


Options:
A: Inclusion Criteria:

MUST HAVE:

General Anesthesia with volatile anesthetic

PATIENT CHARACTERISTICS

Major Criteria (any 1 of the following:)

1. Medications - anticonvulsants, abuse of opiates, benzodiazepines, cocaine
2. EF\<40%
3. Prior history of awareness (recall)
4. History of difficult intubation or anticipated difficult intubation
5. ASA IV or V status
6. Aortic stenosis
7. End stage lung disease
8. Marginal exercise tolerance not secondary to musculoskeletal dysfunction
9. Pulmonary hypertension
10. Daily alcohol consumption

Minor Criteria (any 2 of the following)

1. Beta blockers
2. COPD
3. Moderate exercise tolerance not secondary to musculoskeletal dysfunction
4. Smokes ≥2 packs per day
5. Morbid obesity BMI\>30 -

Exclusion Criteria:

1. Surgical procedure that prevents the use of the BIS (e.g surgery of forehead)
2. Patient positioning prevents use of the BIS
3. Surgery with wake-up test.
4. Less than 18 years of age
5. Vulnerable populations, such as those with dementia and those unable to provide informed consent.
6. Stroke with residual neurological deficits
B: Inclusion Criteria:

* At least 18 years of age, English-speaking, available for follow-up interview at one month.

Exclusion Criteria:

* Pre-existing neurologic or neuropsychiatric condition, surgical manipulation around forehead, not available for follow-up interview.
C: Inclusion Criteria:

MUST HAVE:

General Anesthesia with volatile anesthetic

PATIENT CHARACTERISTICS

Major Criteria (Must have any 1 of the following:)

1. Planned open heart surgery
2. Medications - anticonvulsants, abuse of opiates, benzodiazepines, cocaine
3. EF\<40%
4. Prior history of awareness (recall)
5. History of difficult intubation or anticipated difficult intubation
6. ASA IV or V status
7. Aortic stenosis
8. End stage lung disease
9. Marginal exercise tolerance not secondary to musculoskeletal dysfunction
10. Pulmonary hypertension
11. Daily alcohol consumption

Exclusion Criteria:

1. Surgical procedure that prevents the use of the BIS (e.g. surgery of forehead)
2. Patient positioning prevents use of the BIS
3. Surgery with wake-up test.
4. Less than 18 years of age
5. Vulnerable populations, such as those with dementia and those unable to provide informed consent.
6. Stroke with residual neurological deficits

   -
D: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1 or 2
* General anesthesia for the following operations: Tonsillectomy, Adenoidectomy, Myringoplasty, Myringotomy with tube placement, microlaryngoscopy, bronchoscopy and esophagoscopy.

Exclusion Criteria:

* Psychiatric disorder
* Use of psychotherapeutic, antiepileptic, antiarrhythmic drugs
* Chronic use of opioids
* Intake of more than 21 alcoholic drinks/week
* Missing informed consent

Answer: B