Please select the arm or intervention descriptions that belong 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: Arm Label: BIS Monitor guided algorithm; Type: EXPERIMENTAL; Interventions: Device: BIS Monitor guided algorithm | Arm Label: Volatile anesthetic guided algorithm; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Volatile anesthetic guided algorithm | Intervention Type: DEVICE; Name: BIS Monitor guided algorithm; Assigned to Arm(s): BIS Monitor guided algorithm | Intervention Type: BEHAVIORAL; Name: Volatile anesthetic guided algorithm; Assigned to Arm(s): Volatile anesthetic guided algorithm
B: Arm Label: BIS group; Type: EXPERIMENTAL; Interventions: Device: Bispectral Index Monitor | Arm Label: MAC Alert; Type: ACTIVE_COMPARATOR; Interventions: Device: Electronic MAC alert | Intervention Type: DEVICE; Name: Bispectral Index Monitor; Assigned to Arm(s): BIS group | Intervention Type: DEVICE; Name: Electronic MAC alert; Assigned to Arm(s): MAC Alert
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Bispectral index protocol | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: End tidal anesthetic gas-guided | Intervention Type: BEHAVIORAL; Name: Bispectral index protocol; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: End tidal anesthetic gas-guided; Assigned to Arm(s): 2
D: Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Propofol, Drug: Remifentanil | Arm Label: Bispectral Index Monitor; Type: EXPERIMENTAL; Interventions: Drug: Propofol, Drug: Remifentanil, Device: Bispectral Index Monitor | Intervention Type: DRUG; Name: Propofol; Assigned to Arm(s): Bispectral Index Monitor, Control | Intervention Type: DRUG; Name: Remifentanil; Assigned to Arm(s): Bispectral Index Monitor, Control | Intervention Type: DEVICE; Name: Bispectral Index Monitor; Assigned to Arm(s): Bispectral Index Monitor

Answer: B