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. 2019 Sep 26;2019(9):CD013438. doi: 10.1002/14651858.CD013438

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