Avidan 2009.
Trial name or title | BAG‐RECALL Study: BIS or anesthesia gas to reduce explicit recall |
Methods | Phase IV double‐blind multi‐centre randomised controlled trial |
Participants | Patients aged over 18 undergoing surgery assessed as high risk for awareness requiring general anaesthesia |
Interventions | Group 1: Bispectral index‐guided anaesthesia (target range 40‐60) Group 2: End‐tidal anaesthetic gas‐guided anaesthesia (target range 0.7‐1.3 age‐adjusted minimum alveolar concentration) |
Outcomes | Primary outcome: Awareness with explicit recall during surgical and anaesthetic periods Secondary outcomes: postoperative delirium, postoperative mortality, psychological symptoms, postoperative pain |
Starting date | March 2008 |
Contact information | Michael Avidan avidanm@wustl.edu |
Notes | ClinicalTrials.gov identifier: NCT00682825 Completed December 2010. Published N Engl J Med 2011 Aug 18;365(7):591‐601 but delirium outcome not reported yet. |