Clinical trial NCT01555554: Perioperative Propranolol in Patients With Post Traumatic Stress Disorder (PTSD)
Official title: Effect of Prophylactic, Perioperative Propranolol on Peri- and Postoperative Complications in Patients With Post Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-traumatic Stress Disorder
Keywords: Post-traumatic stress disorder
Propranolol
surgery
anesthesia
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Northern California Institute of Research and Education
First posted: 2012-03-15
Enrollment: 59
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: ICU length of stay
timeFrame: Truncated at 30 days after admission to ICU
measure: Hospital length of stay
timeFrame: Truncated at 30 days after admission to ICU
measure: Postoperative delirium
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Postoperative renal dysfunction
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary outcomes:
measure: Perioperative complications
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Pain intensity
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: Pain unpleasantness
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: Analgesics use
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: Length of intubation and mechanical ventilation
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Post Traumatic Stress Disorder symptomatology
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: Quality of Life
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: Functional status
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: Sleep Quality
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: Depression symptoms
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: Postoperative Neurocognitive Dysfunction Score
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: 30-day, 3-month, and 1-year mortality
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: Postoperative complications
timeFrame: Participants will be followed to 1 year postoperative
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Marek Brzezinski, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: