Prevention of Intraoperative Awareness with Explicit Recall in an Unselected Surgical Population

Author:

Mashour George A.1,Shanks Amy2,Tremper Kevin K.3,Kheterpal Sachin4,Turner Christopher R.5,Ramachandran Satya Krishna4,Picton Paul4,Schueller Christa6,Morris Michelle7,Vandervest John C.8,Lin Nan9,Avidan Michael S.10

Affiliation:

1. Assistant Professor and Associate Chair for Faculty Affairs.

2. Research Specialist and Statistician.

3. Robert B. Sweet Professor and Chair.

4. Assistant Professor.

5. Chief of Anesthesia Service, Bay Area Medical Center, Marinette, Wisconsin.

6. Medical Student, Wayne State University, Detroit, Michigan.

7. Study Coordinator.

8. Programmer, Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, Michigan.

9. Statistician.

10. Professor, Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri.

Abstract

Background Intraoperative awareness with explicit recall occurs in approximately 0.15% of all surgical cases. Efficacy trials based on the Bispectral Index® (BIS) monitor (Covidien, Boulder, CO) and anesthetic concentrations have focused on high-risk patients, but there are no effectiveness data applicable to an unselected surgical population. Methods We conducted a randomized controlled trial of unselected surgical patients at three hospitals of a tertiary academic medical center. Surgical cases were randomized to alerting algorithms based on either BIS values or anesthetic concentrations. The primary outcome was the incidence of definite intraoperative awareness; prespecified secondary outcomes included postanesthetic recovery variables. Results The study was terminated because of futility. At interim analysis the incidence of definite awareness was 0.12% (11/9,376) (95% CI: 0.07-0.21%) in the anesthetic concentration group and 0.08% (8/9,460) (95% CI: 0.04-0.16%) in the BIS group (P = 0.48). There was no significant difference between the two groups in terms of meeting criteria for recovery room discharge or incidence of nausea and vomiting. By post hoc secondary analysis, the BIS protocol was associated with a 4.7-fold reduction in definite or possible awareness events compared with a cohort receiving no intervention (P = 0.001; 95% CI: 1.7-13.1). Conclusion This negative trial could not detect a difference in the incidence of definite awareness or recovery variables between monitoring protocols based on either BIS values or anesthetic concentration. By post hoc analysis, a protocol based on BIS monitoring reduced the incidence of definite or possible intraoperative awareness compared with routine care.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Anesthesiology and Pain Medicine

Reference21 articles.

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