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01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Trials 1/2017

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

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
Anmin Hu, Yan Qiu, Peng Zhang, Bailong Hu, Yali Yang, Shutao Li, Rui Zhao, Zhongjun Zhang, Yaoxian Zhang, Zihao Zheng, Chen Qiu, Furong Li, Xiaolei Gong
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-2233-8) contains supplementary material, which is available to authorized users.

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.
Zusatzmaterial
Additional file 1: SPIRIT checklist. Completed SPIRIT checklist. (PDF 97 kb)
13063_2017_2233_MOESM1_ESM.pdf
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