NCT01555554.
Trial name or title | Perioperative propranolol in patients with post traumatic stress disorder (PTSD) |
Methods | RCT, parallel design |
Participants |
Estimated number of recruited participants: 110 Inclusion criteria: veterans with PTSD; scheduled for any surgical procedure under GA or combined general‐regional anaesthesia, with the exception of open‐heart or intracranial surgery; anticipated postoperative hospital admission (defined as at least 1 overnight hospital stay) Exclusion criteria: on beta‐blocker therapy at the time of the preoperative baseline assessment; sensitivity or allergies to propranolol, or a history of PTSD exacerbation with prior propranolol therapy; veterans who fulfil the AHA/ACC level I recommendation criteria for perioperative beta‐blocker therapy (e.g. metoprolol, atenolol) and should not be randomized to placebo group; medical exclusions criteria: high‐grade heart block without pacemaker (2nd‐ and 3rd degree heart block), marked resting bradycardia (heart rate ≤ 55 bpm), BP < 100 mmHg, uncompensated congested heart failure, severe hyperactive airway disease, and Raynaud's disease; pregnancy; current use of medication that may involve potentially dangerous interaction with propranolol; 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 follow‐up); open‐heart surgery and intracranial surgery Country: USA Setting: hospital; single centre |
Interventions | Propranol orally, started on day of surgery, continued for 14 days Placebo, taken same as the propranolol group |
Outcomes |
Outcomes measured/reported by study authors: ICU length of stay; hospital length of stay; postoperative delirium; postoperative renal dysfunction; perioperative complications; pain intensity; pain unpleasantness; analgesics use; length of intubation and mechanical ventilation; PTSD symptomatology; quality of life; functional status; sleep quality; depression symptoms; postoperative neurocognitive dysfunction score; 30‐day, 3‐months, and 1‐year mortality; postoperative complications Outcomes relevant to the review: early and late mortality; length of hospital stay |
Starting date | May 2012 |
Contact information | Principal Investigator: Marek Brzezinski, MD, PhD, University of California, San Francisco |
Notes |