Perioperative Propranolol in Patients With Post Traumatic Stress Disorder (PTSD)
Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-traumatic Stress Disorder
Intervention: Propranolol Hydrochloride (Drug); Placebo (Other)
Phase: N/A
Status: Recruiting
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s): Marek Brzezinski, M.D., Ph.D., Principal Investigator, Affiliation: University of California, San Francisco
Overall contact: Marek Brzezinski, M.D., Ph.D., Phone: 877-487-2838, Email: brzezinm@anesthesia.ucsf.edu
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.
Clinical Details
Official title: Effect of Prophylactic, Perioperative Propranolol on Peri- and Postoperative Complications in Patients With Post Traumatic Stress Disorder
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: ICU length of stayHospital length of stay Postoperative delirium Postoperative renal dysfunction
Secondary outcome: Perioperative complicationsPain intensity Pain unpleasantness Analgesics use Length of intubation and mechanical ventilation Post Traumatic Stress Disorder symptomatology Quality of Life Functional status Sleep Quality Depression symptoms Postoperative Neurocognitive Dysfunction Score 30-day, 3-month, and 1-year mortality Postoperative complications
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Marek Brzezinski, M.D., Ph.D., Phone: 877-487-2838, Email: brzezinm@anesthesia.ucsf.edu
San Francisco VA Medical Center, San Francisco, California 94121, United States; Recruiting Marek Brzezinski, M.D., Ph.D., Principal Investigator Hubert Kim, MD, Sub-Investigator Thomas Neylan, M.D., Sub-Investigator Kristin Samuelson, Ph.D., Sub-Investigator Arthur Wallace, M.D. Ph.D., Sub-Investigator
Additional Information
Starting date: May 2012
Last updated: April 13, 2015
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