Perioperative Propranolol in Patients With Post Traumatic Stress Disorder (PTSD)
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 5/19/2018 |
| Start Date: | May 2012 |
| End Date: | June 2019 |
| Contact: | Marek Brzezinski, M.D., Ph.D. |
| Email: | brzezinm@anesthesia.ucsf.edu |
| Phone: | 877-487-2838 |
Effect of Prophylactic, Perioperative Propranolol on Peri- and Postoperative Complications in Patients With Post Traumatic Stress Disorder
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.
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.
Inclusion Criteria:
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
2. Anticipated postoperative hospital admission (defined as at least one overnight
hospital stay)
Exclusion Criteria:
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
We found this trial at
1
site
San Francisco, California 94121
Principal Investigator: Marek Brzezinski, M.D., Ph.D.
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