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Summary

for people ages 40 years and up (full criteria)
at San Francisco, California
study started
estimated completion:

Description

Summary

Understanding what treatments may facilitate perioperative care of Veterans with posttraumatic stress disorder (PTSD) is of great importance to the U.S. health care system. Patients with PTSD are characterized by elevated central nervous system catecholamine concentrations and exaggerated and prolonged adrenergic responses to stress stimuli. At present, there are no data on the effects of perioperative beta blocker therapy in patients with PTSD, despite the rising significance of PTSD in Veteran populations. This prospective, double-blind study proposes to randomize 150 Veterans with PTSD scheduled for orthopedic, thoracic or vascular surgery at the San Francisco VA Medical Center to either a 14-day course of propranolol or placebo. This study will then follow these Veterans for a one-year period to evaluate the effects of the intervention on Veterans' surgical outcomes. The investigators hypothesize that patients with PTSD randomized to the propranolol group will demonstrate a reduced incidence of perioperative and postoperative morbidity and mortality.

Official Title

Effect of Prophylactic, Perioperative Propranolol on Peri- and Postoperative Complications in Patients With Post Traumatic Stress Disorder

Keywords

Post-traumatic Stress Disorder Propranolol surgery anesthesia Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Postoperative Complications

Eligibility

You can join if…

Open to people ages 40 years and up

  1. Subjects scheduled for any surgical procedure under general anesthesia or combined general-regional anesthesia, with the exception of open-heart or intracranial surgery.

Regional anesthesia includes: 1) Epidural anesthesia, 2) Sub-arachnoid block (spinal),or 3)any regional nerve block

  1. Anticipated postoperative hospital admission (defined as at least one overnight hospital stay)

You CAN'T join if...

Veterans will be excluded if:

  1. They are on beta blocker therapy at the time of the preoperative baseline assessment
  2. They report sensitivity or allergies to propranolol, or a history of PTSD exacerbation with prior propranolol therapy
  3. Veterans who fulfill the AHA/ACC level I recommendation criteria for perioperative beta blocker therapy (e.g., metoprolol, atenolol) and should not be randomized to placebo group
  4. Medical exclusions criteria: high grade heart block without pacemaker (all patients with 2nd and 3rd degree heart block), marked resting bradycardia (heart rate ≤ 55 beats per minute), blood pressure < 100 mmHg, uncompensated congested heart failure,severe hyperactive airway disease, and Raynaud's disease
  5. Pregnancy
  6. Current use of medication that may involve potentially dangerous interaction with propranolol
  7. Circumstances that, in the opinion of the principal investigator, would preclude participation in a study of this type (e.g. medical concerns or difficulty in long-term followup).
  8. Open-heart surgery and intracranial surgery

Location

  • San Francisco VA Medical Center accepting new patients
    San Francisco, California, 94121, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT01555554
Lead Scientist
Marek Brzezinski
Study Type
Interventional
Last Updated
August 2016