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临床试验/NCT05424510
NCT05424510已完成不适用

Prevention of Hypotension After Induction of General Anesthesia Using POint-of-care Ultrasound to Guide Fluid Management: a Randomized Controlled Trial

Mount Sinai Hospital, Canada1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年7月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Difference in the incidence of hypotension after induction of general anesthesia

研究概览

简要总结

Hypotension is a common side-effect of general anesthesia induction, and is related to adverse outcomes, including a significantly increased risk of one-year mortality. Hypovolemia is a significant risk factor, and optimized fluid therapy remains the cornerstone of its treatment. Ultrasound measurements of inferior vena cava (IVC) diameter with respiration have been recommended as rapid and noninvasive methods for estimating volume status. Several recent studies reported that preoperative IVC ultrasound has a reliable predicting ability of arterial hypotension after the induction of general anesthesia. The practical effect of optimizing fluid status before surgery using this ability has not been studied. Our hypothesis is that preoperative ultrasound-guided intravenous fluid bolus administration may reduce the incidence of hypotension after the induction of general anesthesia in adults presenting for elective non-cardiac, non-obstetric surgery

详细描述

Background: Hypotension is a common side-effect of general anesthesia induction, and is related to adverse outcomes, including significantly increasing risk of one-year mortality (intraoperative systolic hypotension increased mortality risk by 3.6% per minute below 80 mm Hg). Even short durations of intraoperative hypotension have been associated with acute kidney injury (AKI) and myocardial injury.

The feasibility of POCUS in directing fluid management to prevent hypotension has been demonstrated after the induction of spinal anesthesia but not general anesthesia.

Design: This will be a randomized controlled trial. All participating patients will undergo a bed-side ultrasound scan and assessment of the IVC-CI. Patients with collapsible IVC, defined as a CI equal or greater than 43%, will be randomized 1:1 to either receive a fluid bolus or not. We will test the potential efficacy of an ultrasound directed fluid bolus in reducing the hypotension associated with the induction of general anesthesia. This will be a single blinded study with the attending anesthesiologist unaware to patient group allocation and POCUS data.

The primary objective is to determine the efficacy of preoperative POCUS-guided intravenous fluid bolus administration in reducing the incidence of hypotension after the induction of general anesthesia in adults presenting for elective non-cardiac, non-obstetric surgery.

While in the preoperative area, patients who fulfil the eligibility criteria will be approached for recruitment, informed consent, and voluntary participation. Written informed consent will be obtained from all patients. Upon informed consent, baseline characteristics will be collected which include demographic information, past medical history including medical therapy, and the type of scheduled surgery. Thereafter the assessment of preoperative IVC-CI will be performed, with patients with an IVC-CI ≥ 43% randomized into the intervention and control groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Care Provider)

盲法说明

In all fluid responsive patients an IV line will be placed, regardless of group allocation into FB+ or FB-. In order to maintain masking of the treating anesthesiologist, patients will be advised regarding the importance to not disclose whether they received a fluid bolus or not to their anesthetist.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-70 years
  • Elective surgery
  • IVC-CI ≥ 43% on their preoperative POCUS scan.

排除标准

  • Hypotension, defined as MAP below 65 mmhg, prior to the induction of general anesthesia.
  • Treated with angiotensin converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARB) on the day of surgery.
  • Patients with heart failure with ejection fraction (EF) < 40%.
  • Patients with documented acute or chronic renal failure.
  • Patients with neuraxial blockade (epidural or spinal) performed before induction of general anesthesia.

研究组 & 干预措施

Fluid Bolus (FB+)

Active Comparator

Patients in the FB+ group will receive a single bolus of 500 ml of Ringer's Lactate over 5-10 minutes.

干预措施: Ringer's Lactate (Drug)

Fluid Bolus (FB+)

Active Comparator

Patients in the FB+ group will receive a single bolus of 500 ml of Ringer's Lactate over 5-10 minutes.

干预措施: IV line (Other)

Non fluid bolus (FB-)

Placebo Comparator

Patients in the FB- group will not receive a fluid bolus.

干预措施: IV line (Other)

结局指标

主要结局

Difference in the incidence of hypotension after induction of general anesthesia

时间窗: 20 minutes from the induction of general anesthesia

hypotension as MAP below an absolute threshold of 65 mmhg or relative threshold of 25% decrease from baseline, or the administration of vasopressors during the induction period

次要结局

  • The incidence of surgical delays(Patient consent until the beginning of the operation)
  • The duration of post-induction hypotension(20 minutes after induction)
  • Adverse events(20 minutes after induction)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Khan

Pain Physician and Anesthesiologist

Mount Sinai Hospital, Canada

研究点 (1)

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