Jacqueline M Leung1, Laura P Sands, Ningning Chen, Christopher Ames, Sigurd Berven, Kevin Bozic, Shane Burch, Dean Chou, Kenneth Covinsky, Vedat Deviren, Sakura Kinjo, Joel H Kramer, Michael Ries, Bobby Tay, Thomas Vail, Philip Weinstein, Stacey Chang, Gabriela Meckler, Stacey Newman, Tiffany Tsai, Vanessa Voss, Emily Youngblom. 1. From the Departments of Anesthesia and Perioperative Care (J.M.L., S.K.), Neurosurgery (C.A., D.C., P.W.), Orthopedic Surgery (S. Bergven, S. Burch, V.D., M.R., B.T., T.V.), and Medicine (K.C.) and Memory and Aging Center (J.H.K.), University of California San Francisco, San Francisco, California; Virginia Tech, Blacksburg, Virginia (L.P.S.); Department of Statistics, Purdue University, West Lafayette, Indiana (N.C.); Department of Surgery & Perioperative Care, Dell Medical School, University of Texas at Austin, Austin, Texas (K.B.). participated in patient recruitment, cognitive assessments, data entry, and data management participated in patient recruitment, cognitive assessments, data entry, and data management participated in patient recruitment, cognitive assessments, data entry, and data management participated in patient recruitment, cognitive assessments, data entry, and data management participated in patient recruitment, cognitive assessments, data entry, and data management participated in patient recruitment, cognitive assessments, data entry, and data management.
Abstract
BACKGROUND:Postoperative pain and opioid use are associated with postoperative delirium. We designed a single-center, randomized, placebo-controlled, parallel-arm, double-blinded trial to determine whether perioperative administration of gabapentin reduced postoperative deliriumafter noncardiac surgery. METHODS: Patients were randomly assigned to receive placebo (N = 347) or gabapentin 900 mg (N = 350) administered preoperatively and for the first 3 postoperative days. The primary outcome was postoperative delirium as measured by the Confusion Assessment Method. Secondary outcomes were postoperative pain, opioid use, and length of hospital stay. RESULTS: Data for 697 patients were included, with a mean ±SD age of 72 ± 6 yr. The overall incidence of postoperative delirium in any of the first 3 days was 22.4% (24.0% in the gabapentin and 20.8% in the placebo groups; the difference was 3.20%; 95% CI, 3.22% to 9.72%; P = 0.30). The incidence of delirium did not differ between the two groups when stratified by surgery type, anesthesia type, or preoperative risk status. Gabapentin was shown to be opioid sparing, with lower doses for the intervention group versus the control group. For example, the morphine equivalents for the gabapentin-treated group, median 6.7 mg (25th, 75th quartiles: 1.3, 20.0 mg), versus control group, median 6.7 mg (25th, 75th quartiles: 2.7, 24.8 mg), differed on the first postoperative day (P = 0.04). CONCLUSIONS: Although postoperative opioid use was reduced, perioperative administration of gabapentin did not result in a reduction of postoperative delirium or hospital length of stay.
RCT Entities:
BACKGROUND:Postoperative pain and opioid use are associated with postoperative delirium. We designed a single-center, randomized, placebo-controlled, parallel-arm, double-blinded trial to determine whether perioperative administration of gabapentin reduced postoperative delirium after noncardiac surgery. METHODS:Patients were randomly assigned to receive placebo (N = 347) or gabapentin 900 mg (N = 350) administered preoperatively and for the first 3 postoperative days. The primary outcome was postoperative delirium as measured by the Confusion Assessment Method. Secondary outcomes were postoperative pain, opioid use, and length of hospital stay. RESULTS: Data for 697 patients were included, with a mean ± SD age of 72 ± 6 yr. The overall incidence of postoperative delirium in any of the first 3 days was 22.4% (24.0% in the gabapentin and 20.8% in the placebo groups; the difference was 3.20%; 95% CI, 3.22% to 9.72%; P = 0.30). The incidence of delirium did not differ between the two groups when stratified by surgery type, anesthesia type, or preoperative risk status. Gabapentin was shown to be opioid sparing, with lower doses for the intervention group versus the control group. For example, the morphine equivalents for the gabapentin-treated group, median 6.7 mg (25th, 75th quartiles: 1.3, 20.0 mg), versus control group, median 6.7 mg (25th, 75th quartiles: 2.7, 24.8 mg), differed on the first postoperative day (P = 0.04). CONCLUSIONS: Although postoperative opioid use was reduced, perioperative administration of gabapentin did not result in a reduction of postoperative delirium or hospital length of stay.
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