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Perioperative Propranolol in Patients With Post Traumatic Stress Disorder (PTSD)

Information source: University of California, San Francisco
Information obtained from ClinicalTrials.gov on February 07, 2013
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 stay

Hospital length of stay

Postoperative delirium

Postoperative renal dysfunction

Secondary outcome:

Perioperative complications

Pain 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: 55 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

To be eligible, participants must be:

1. Veterans scheduled for an orthopedic, thoracic, or vascular procedure under general anesthesia or combined general-regional anesthesia. Regional anesthesia includes: a) Epidural anesthesia, b) Sub-arachnoid block (spinal), or c) any regional nerve block

2. Anticipated postoperative hospital admission

3. Subjects positive for full syndromal PTSD of at least 3 months duration as indexed by the Clinician Administered PTSD Scale(CAPS)

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, Raynaud's disease, and head injury [head trauma requiring hospitalization documented in the medical chart or reported by patient]

5. History of schizophrenia or schizoaffective disorder, bipolar disorder as assessed by the Structured Clinical Interview for DSM-IV

6. Change in PTSD treatment within the last month prior to baseline assessment

7. Pregnancy

8. Prominent suicidal or homicidal ideations

9. Current use of medication that may involve potentially dangerous interaction with propranolol

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: May 29, 2012

Page last updated: February 07, 2013

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