跳至主要内容
临床试验/NCT03121092
NCT03121092终止不适用

Should Ambulatory Surgery and Day of Surgery Admission Patients Discontinue Angiotensin Converting Enzyme Inhibitors (ACEI's) and Angiotension Receptor Blockers (ARB's) Preoperatively?

State University of New York - Downstate Medical Center1 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2012年5月16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
终止
发起方
入组人数
188
试验地点
1
主要终点
Presence of moderate hypotension

研究概览

简要总结

Angiotensin converting enzyme inhibitors (ACEI's) and Angiotensin receptor blockers (ARB's) are commonly used anti-hypertensive medications that may have implications on the management of a patient undergoing surgery. Limited research has looked at the effects of these medications on perioperative complications and mortality. Some studies conducted on small groups of inpatients with advanced vascular disease undergoing vascular surgery or coronary artery bypass grafting (CABG), suggest exacerbation of hypotension (low blood pressure) in patients who continued taking ACEI's or ARB's on the morning of their procedure. In addition, cases of low blood pressure (BP) that were refractory to standard treatment were reported. One recent retrospective study reported no difference in severe hypotension and only a modest difference in moderate hypotension managed by conventional treatment, but did not adequately address the risk of preoperative hypertension. A study recently published by the investigators (Twersky et al., 2014) in over 600 patients demonstrated no difference in preoperative hypertension in ambulatory surgery and same day admission patients. There has been limited data stratifying the degree of low BP based on severity but these were not done in ambulatory patients, and neither was the degree of high BP from discontinuing these medications addressed. As such, no uniform consensus has been reached and clinicians are unclear as to whether the reported inpatient findings are applicable to the outpatients, since they differ in many respects. The investigators propose to evaluate whether ACEI's and ARB's discontinued preoperatively have a negative impact on perioperative hemodynamics and patient outcome in a group of ambulatory and same day surgical patients. Similar to studies done on inpatients, the investigators will also evaluate patients receiving a standardized general anesthetic for hemodynamics following induction of anesthesia until surgical incision.

The investigators hypothesize that continuing ACEI's and ARB's in the preoperative period does not result in an increased risk of severe hypotension (low blood pressure) following induction of general anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

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

入选标准

  • patients over the age of 18
  • patients scheduled to undergo any surgical procedure on an ambulatory basis or on a same day admission basis
  • patients undergoing general anesthesia by Laryngeal Mask Airway (LMA)
  • patients taking chronic ACEI or ARB drug treatment for hypertension for more than 6 weeks
  • patients on diuretics and/or beta blockers and/or calcium channel blockers for hypertension in addition to the ACEI or ARB (alone or in combination) for hypertension may be included
  • patients taking any cardiovascular medications may be included

排除标准

  • patients taking both an ACEI and an ARB simultaneously
  • patients taking ACEI or ARB for less than 6 weeks
  • patients with uncontrolled hypertension during pre-surgical testing (PST) visit, defined as Systolic (SBP) > 180 or Diastolic (DBP) > 100 (Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure JNC 7)
  • patients with history of unstable heart disease, refractory congestive heart failure, hypertensive stroke, mini stroke, stroke or heart attack within the past 6 months
  • emergency surgery
  • patients who are pregnant
  • patients whose surgery requires endotracheal intubation

研究组 & 干预措施

Continue ACEI or ARB

Active Comparator

Patients in this group will take an ACE or ARB on the day of surgery.

干预措施: ACEI or ARB (Drug)

结局指标

主要结局

Presence of moderate hypotension

时间窗: Through study completion, projected 2-3 years

Presence of moderate hypotension (SBP\<90 or a change of \>30% from pre-induction baseline), in the intraoperative setting and in the post-anesthesia care unit

Presence of severe hypotension

时间窗: Through study completion, projected 2-3 years

Presence of severe hypotension (SBP\<65) between induction and incision

次要结局

  • The prevalence of cancellation of surgery secondary to unstable BP(Through study completion, projected 2-3 years)
  • The number and dose of medications to treat BP(Through study completion, projected 2-3 years)
  • prevalence of adverse effects (increased length of stay in the PACU, unanticipated hospitalizations, myocardial ischemia, stroke, death)(Through study completion, projected 2-3 years)

研究者

发起方
State University of New York - Downstate Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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