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Comparison of the effect of high versus low mean arterial pressure levels on clinical outcomes and complications in elderly patients during non-cardiothoracic surgery under general anesthesia: study protocol for a randomized controlled trial.

Comparison of the effect of high versus low mean arterial pressure levels on clinical outcomes and complications in elderly patients during non-cardiothoracic surgery under general anesthesia: study protocol for a randomized controlled trial.
Author Information (click to view)

Hu A, Qiu Y, Zhang P, Hu B, Yang Y, Li S, Zhao R, Zhang Z, Zhang Y, Zheng Z, Qiu C, Li F, Gong X,


Hu A, Qiu Y, Zhang P, Hu B, Yang Y, Li S, Zhao R, Zhang Z, Zhang Y, Zheng Z, Qiu C, Li F, Gong X, (click to view)

Hu A, Qiu Y, Zhang P, Hu B, Yang Y, Li S, Zhao R, Zhang Z, Zhang Y, Zheng Z, Qiu C, Li F, Gong X,

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Trials 2017 11 2118(1) 554 doi 10.1186/s13063-017-2233-8
Abstract
BACKGROUND
Intraoperative blood pressure (BP) is a concern in daily clinic anesthesia and contributes to the differences in clinical outcome. We conducted a randomized controlled trial (RCT) to compare the effect of high vs. low mean arterial pressure (MAP) levels on clinical outcomes and complications in elderly patients under general anesthesia (GA).

METHODS
In this multicenter, randomized, parallel-controlled, open-label, assessor-blinded clinical trial, 322 patients aged more than 65 years will be randomized for a low-level MAP (60-70 mmHg) or high-level MAP (90-100 mmHg) during non-cardiothoracic surgery under GA. The primary outcome will be the incidence of postoperative delirium. The secondary outcomes will include the delirium duration days, intraoperative urine volume, intraoperative blood loss, specific postoperative complications, and all-cause 28-day mortality.

DISCUSSION
Results of this trial will help clarify whether BP management is beneficial for elderly patients under GA and will make clear whether the effect of high-level MAP can reduce the postoperative complication compared to low-level MAP.

TRIAL REGISTRATION
ClinicalTrials.gov, NCT02857153 . Registered on 15 July 2016.

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