Key result
Intraoperative optimization of tissue oxygenation targeting StO2 >= 80% did not significantly reduce the number of postoperative complications compared to standard care (11 vs 20 complications; p=0.23).
Why the study?
Does intra-operative optimisation of StO2 with dobutamine reduce postoperative complications in high-risk patients undergoing major abdominal surgery?
RCT (n=50)
Single-blind
Sealed envelopes
No
Does intra-operative optimisation of StO2 with dobutamine reduce postoperative complications in high-risk patients undergoing major abdominal surgery?
Absolute Event Rate: 11% vs 20%
p-value: p=0.23
Intraoperative goal-directed therapy targeting tissue oxygenation (StO2 ≥ 80%) with dobutamine did not significantly reduce postoperative complications in high-risk patients undergoing major abdominal surgery.
StO2 optimization does not reduce postoperative complications; challenges goal-directed therapy assumptions and leaves open refined targets in major surgery.
BACKGROUND: Tissue hypoperfusion occurs frequently during surgery and may contribute to postoperative organ dysfunction. There is a need for perioperative treatment protocols aiming at improving tissue oxygenation (StO2). We hypothesised that intra-operative optimisation of StO2 improves tissue perfusion and thus reduces postoperative complications. Furthermore, we evaluated the feasibility of the optimisation algorithm used. METHODS: We randomized 50 high-risk patients, all >65 years with ASA physical status III, who underwent major abdominal surgery under standardized balanced general anesthesia combined with epidural analgesia. Throughout surgery StO2 was monitored at the thenar eminence using near-infrared spectroscopy. All patients were treated according to a standard care algorithm. In addition, patients in the intervention group were treated with dobutamine if necessary to keep or raise StO2 ≥ 80%. Data were recorded continuously and complications were recorded during hospital stay with a maximum of 28 days. RESULTS: The number of complications was not significantly different between groups (11 vs 20; p = 0.23). Eleven patients in the intervention group had no complication, versus 7 in the control group. There was no significant difference between groups in length of stay in ICU or in hospital. Only ten patients in the intervention group received dobutamine. Administration of dobutamine resulted in a moderate 6 [-3 to 10] % increase of StO2. The overall protocol adherence was 94%. CONCLUSIONS: No statistically significant difference in outcome was realized through intraoperative optimization of StO2 values in this pilot study. The protocol used may be considered feasible for clinical practice. Further research is obligatory to define both the optimal StO2 threshold and intervention to treat tissue hypoperfusion. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01342900. Registered 21 April 2011.
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Beest et al. (2014) conducted an RCT in High-risk surgery (n=50). Intraoperative tissue oxygenation (StO2) optimization protocol vs. Standard care algorithm was evaluated on Number of postoperative complications (p=0.23). Intraoperative optimization of tissue oxygenation targeting StO2 >= 80% did not significantly reduce the number of postoperative complications compared to standard care (11 vs 20 complications; p=0.23).
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