Perioperative Propranolol in Patients With Post Traumatic Stress Disorder (PTSD)
NCT ID: NCT01555554
Last Updated: 2021-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
59 participants
INTERVENTIONAL
2012-05-31
2019-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Propranolol Hydrochloride
Propranolol Hydrochloride
Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
Placebo Group
Placebo
The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
Interventions
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Propranolol Hydrochloride
Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
Placebo
The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Anticipated postoperative hospital admission (defined as at least one overnight hospital stay)
Exclusion Criteria
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
40 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Northern California Institute of Research and Education
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Marek Brzezinski, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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San Francisco VA Medical Center
San Francisco, California, United States
Countries
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Other Identifiers
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W81XWH-10-2-0078
Identifier Type: -
Identifier Source: org_study_id
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