Basem B Abdelmalak1, Jing You2, Andrea Kurz3, Michael Kot4, Thomas Bralliar5, Feza H Remzi6, Daniel I Sessler7. 1. Department of General Anesthesiology, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, United States of America. Electronic address: abdelmb@ccf.org. 2. Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, United States of America. 3. Department of General Anesthesiology, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, United States of America. 4. Department of Cardiothoracic Anesthesiology, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, United States of America. 5. Department of General Anesthesiology, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, United States of America. 6. Department of Surgery, Inflammatory Bowel Disease Center, NYU Langone Health, NY, NY, United States of America. 7. Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, United States of America.
Abstract
STUDY OBJECTIVES: The postoperative period is associated with an inflammatory response that may contribute to a number of complications including postoperative fatigue (POF) that impair patients' quality of life (QoL). We studied the impact of three potentially anti-inflammatory interventions (steroid administration, tight intraoperative glucose control, and light anesthesia) on POF and QoL in patients having major noncardiac surgery. DESIGN: A randomized Trial. SETTING: Operating room and postoperative recovery area/ICU/hospital floors. PATIENTS: Patients undergoing major noncardiac surgery. INTERVENTIONS: Patients were randomized to perioperative IV dexamethasone (a total of 14 mg tapered over 3 days) versus placebo, intensive versus conventional glucose control (target 80-110 vs. 180-200 mg·dL-1), and light versus deep anesthesia (Bispectral Index target of 55 vs. 35) in a 3-way factorial design. MEASUREMENTS: In this planned sub-analysis, QoL was measured using SF-12 preoperatively and on postoperative day (POD) 30. POF was measured using Christensen VAS, pre-operatively, POD 1, and POD 3. We assessed the effect of each intervention on POF and on the physical and mental components of SF-12 summary scores with repeated-measures linear regression models. MAIN RESULTS:326 patients with complete data were included in the SF-12 analysis and 306 were included in the QoL analysis. No difference was found between any of the intervention groups on fatigue or mean 30-day physical and mental components of SF-12 scores, after adjusting for preoperative score and imbalanced baseline variables (all P-value >0.07 for POF and >0.40 for QoL). CONCLUSIONS:Steroid administration, tight intraoperative glucose control, and light anesthesia do not improve quality of life or postoperative fatigueafter major surgery.
RCT Entities:
STUDY OBJECTIVES: The postoperative period is associated with an inflammatory response that may contribute to a number of complications including postoperative fatigue (POF) that impair patients' quality of life (QoL). We studied the impact of three potentially anti-inflammatory interventions (steroid administration, tight intraoperative glucose control, and light anesthesia) on POF and QoL in patients having major noncardiac surgery. DESIGN: A randomized Trial. SETTING: Operating room and postoperative recovery area/ICU/hospital floors. PATIENTS: Patients undergoing major noncardiac surgery. INTERVENTIONS:Patients were randomized to perioperative IV dexamethasone (a total of 14 mg tapered over 3 days) versus placebo, intensive versus conventional glucose control (target 80-110 vs. 180-200 mg·dL-1), and light versus deep anesthesia (Bispectral Index target of 55 vs. 35) in a 3-way factorial design. MEASUREMENTS: In this planned sub-analysis, QoL was measured using SF-12 preoperatively and on postoperative day (POD) 30. POF was measured using Christensen VAS, pre-operatively, POD 1, and POD 3. We assessed the effect of each intervention on POF and on the physical and mental components of SF-12 summary scores with repeated-measures linear regression models. MAIN RESULTS: 326 patients with complete data were included in the SF-12 analysis and 306 were included in the QoL analysis. No difference was found between any of the intervention groups on fatigue or mean 30-day physical and mental components of SF-12 scores, after adjusting for preoperative score and imbalanced baseline variables (all P-value >0.07 for POF and >0.40 for QoL). CONCLUSIONS:Steroid administration, tight intraoperative glucose control, and light anesthesia do not improve quality of life or postoperative fatigue after major surgery.