Glucose variability and mode of anaesthesia in major noncardiac surgery (GlucoVITAL): study protocol for a randomised controlled trial

Henrike Janssen , Priyanthi Dias , Louise Hiller , Russell Hewson , Rupert M. Pearse , Nick S. Oliver , Shaman Jhanji , Gareth L. Ackland
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引用次数: 0

Abstract

Background

Hyperglycaemia after noncardiac surgery occurs commonly and is associated with complications. The choice of maintenance anaesthesia may promote hyperglycaemia and increase glucose variability, both of which exacerbate inflammation and organ dysfunction. We hypothesise that total intravenous anaesthesia reduces glucose variability, particularly in individuals with insulin resistance or diabetes mellitus, and hence may reduce postoperative complications.

Methods

This multicentre, randomised controlled parallel group trial will recruit 450 participants ≥50 yr undergoing elective noncardiac surgery. Participants will be randomly allocated in a 1:1 ratio (with minimisation) to receive either total intravenous anaesthesia or inhalation agents (typically sevoflurane) for maintenance of anaesthesia. The primary outcome is blood glucose, measured at prespecified timepoints (before, immediately after, and the morning after surgery). Continuous glucose monitoring (CGM; Dexcom G7) will commence at induction of anaesthesia for up to 10 days after surgery (or hospital discharge) to establish the reliability and accuracy of CGM compared with blood glucose measurements. Secondary outcomes include days alive and out of hospital within 30 days of surgery and postoperative complications (Clavien–Dindo grade ≥2). Absolute glucose and CGM-derived measures of glucose variability will be compared between participants who sustain, or remain free of, myocardial injury within 24 h of surgery, infectious complications within 30 days of surgery, and vasopressor use persisting >4 h after surgery.

Conclusions

GlucoVITAL will establish whether the mode of anaesthesia may alter glucose control in susceptible individuals and also explore the role of glucose variability in organ injury after noncardiac surgery using CGM.

Clinical trial registration

ISRCTN46862025.
重大非心脏手术(GlucoVITAL)中葡萄糖变异性和麻醉方式:随机对照试验的研究方案
背景:非心脏手术后高血糖很常见,并伴有并发症。维持麻醉的选择可能会促进高血糖和增加葡萄糖变异性,这两者都会加剧炎症和器官功能障碍。我们假设全静脉麻醉降低了葡萄糖变异性,特别是在胰岛素抵抗或糖尿病患者中,因此可能减少术后并发症。该多中心、随机对照平行组试验将招募450名年龄≥50岁、接受选择性非心脏手术的参与者。参与者将按1:1的比例随机分配(尽量减少),接受全静脉麻醉或吸入剂(通常为七氟醚)以维持麻醉。主要结果是在预先指定的时间点(手术前、手术后和手术后的早晨)测量血糖。连续血糖监测(CGM);Dexcom G7)将在手术后(或出院后)诱导麻醉10天内开始,以确定CGM与血糖测量的可靠性和准确性。次要结局包括手术30天内存活天数和出院天数以及术后并发症(Clavien-Dindo分级≥2)。绝对葡萄糖和cgm衍生的葡萄糖变异性测量将在手术后24小时内持续或未发生心肌损伤、手术后30天内感染并发症和术后持续使用血管加压剂4小时的参与者之间进行比较。结论glucovital将确定麻醉方式是否会改变易感个体的血糖控制,并探讨葡萄糖变异性在CGM非心脏手术后器官损伤中的作用。临床试验注册号:isrctn46862025。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BJA open
BJA open Anesthesiology and Pain Medicine
CiteScore
0.60
自引率
0.00%
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审稿时长
83 days
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