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

Abstract

BackgroundIntraoperative 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).MethodsIn 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.DiscussionResults 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 registrationClinicalTrials.gov, NCT02857153. Registered on 15 July 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2233-8) contains supplementary material, which is available to authorized users.

A systematic review and meta-analysis on the curative effects of cardiothoracic surgery for critical patients in the intensive care unit

“…A systematic review and meta-analysis on the curative effects of cardiothoracic surgery for critical patients in the intensive care unit and have low cardiorespiratory function capacity, increasing the risk of surgery (4). Additionally, during the process of CTS, cardiopulmonary function will further decline due to unavoidable anesthetics, surgical trauma stimulation, postoperative pain, and lung infection, severely damaging the body's immunity and negatively affecting the patient's rapid recovery (5).…”

“…Figures 3,4 are the results of the risk bias evaluation of studies plotted by Rev Man 5.3 software. Of the 15 RCTs, 3 (10-12) had the correct random allocation method and only 2 (13,14) had allocation concealment.…”