Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery
Condition: Hypotension on Induction
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and
      including the morning of a non-cardiac, non-vascular surgery will experience more
      intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.

      Secondary research hypothesis #1: Patients who continue their chronic ACEI up to and
      including the morning of a non-cardiac, non-vascular surgery will experience better
      postoperative control of hypertension than those who transiently hold their chronic ACEI
      preoperatively.

      Secondary research hypothesis #2: Patients who continue their chronic ACEI up to and
      including the morning of a non-cardiac, non-vascular surgery will experience less acute renal
      failure than those who transiently hold their chronic ACEI preoperatively.

      Secondary research hypothesis #3: In the subgroup of patients with a preoperative systolic
      blood pressure less than 110 mmHg, those who continue their chronic ACEI therapy up to and
      including the morning of a non-cardiac, non-vascular surgery will experience more
      intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.

      Secondary research hypothesis #4: In the subgroup of patients above the age of 64, those who
      continue their chronic ACEI therapy up to and including the morning of a non-cardiac,
      non-vascular surgery will experience more intraoperative hypotension than those who
      transiently hold their chronic ACEI preoperatively.
    

Detailed description: 
      The purpose of this study is to determine if transient discontinuation of angiotensin
      converting enzyme inhibitors (ACEIs) is necessary prior to non-cardiac, non-vascular surgery.
      ACEIs have been associated with intraoperative hypotension during vascular and cardiac
      surgeries. Patients presenting to the University of Nebraska Medical Center Pre-Anesthesia
      Screening (PAS) Clinic who are on chronic ACEI therapy will be eligible for enrollment.
      Subjects will be randomized to either omit or continue their ACEI preoperatively. The outcome
      of interest is intraoperative hypotension defined as a systolic blood pressure less than 80
      mmHg. Blood pressure will be followed not only throughout surgery, but also during recovery
      and the remainder of hospitalization. Renal function will be assessed with creatinine
      measurements in the PAS clinic and on the first postoperative day. No follow-up is planned
      beyond discharge from the hospital.
    

Intervention name(s): ACEI continuation; ACEI omission
Intervention type(s): Drug; Drug
Intervention description(s): These chronic medications will be taken without interruption preoperatively.; Although taken chronically by patients in this intervention, the final preoperative dose of these medications will be omitted, whether it was scheduled for the morning of surgery or the day prior.
Other intervention name(s): quinapril; Accupril; perindopril; Aceon; ramipril; Altace; benazepril; Lotensin; captopril; Capoten; enalapril; Vasotec; fosinopril; Monopril; lisinopril; Prinivil; Zestril; trandolapril; Mavik; moexipril; Univasc; quinapril; Accupril; perindopril; Aceon; ramipril; Altace; benazepril; Lotensin; captopril; Capoten; enalapril; Vasotec; fosinopril; Monopril; lisinopril; Prinivil; Zestril; trandolapril; Mavik; moexipril; Univasc
Intervention MeSH terms: Ramipril; Enalapril; Enalaprilat; Lisinopril; Perindopril; Captopril; Benazepril; Quinapril; Trandolapril; Fosinopril; Moexipril; Angiotensin-Converting Enzyme Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Perioperative Period