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

NCT01555554 | Terminated

• 1 other identifier: W81XWH-10-2-0078
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Stress Disorder

Keywords

Post-traumatic stress disorder; Propranolol; surgery; anesthesia

Outcome Measures

Primary Outcomes (4)

• ICU length of stay

  Measured using patient medical records

  Truncated at 30 days after admission to ICU

• Hospital length of stay

  Measured using patient medical records

  Truncated at 30 days after admission to ICU

• Postoperative delirium

  Measured using Confusion Assessment Method (CAM-CAM-ICU)

  Participants will be followed for the duration of hospital stay, an expected average of 1 week

• Postoperative renal dysfunction

  Measured using Serum Creatinine laboratory values

  Participants will be followed for the duration of hospital stay, an expected average of 1 week

Secondary Outcomes (13)

• Perioperative complications

  Participants will be followed for the duration of hospital stay, an expected average of 1 week

• Pain intensity

  Participants will be followed from preoperative baseline to 1 year postoperative

• Pain unpleasantness

  Participants will be followed from preoperative baseline to 1 year postoperative

• Analgesics use

  Participants will be followed from preoperative baseline to 1 year postoperative

• Length of intubation and mechanical ventilation

  Participants will be followed for the duration of hospital stay, an expected average of 1 week

Study Arms (2)

Propranolol Hydrochloride

EXPERIMENTAL

Drug: Propranolol Hydrochloride

Placebo Group

PLACEBO COMPARATOR

Other: Placebo

Interventions

Propranolol Hydrochloride DRUG

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.

Also known as: Inderal, Inderal LA, Avlocardyl, Avlocardyl Retard, Deralin, Dociton, Inderalici, InnoPran XL, Sumial, Anaprilinum, Bedranol SR Sandoz

Propranolol Hydrochloride

Placebo OTHER

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.

Placebo Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Anticipated postoperative hospital admission (defined as at least one overnight hospital stay)

You may not qualify if:

• Veterans will be excluded if:
• They are on beta blocker therapy at the time of the preoperative baseline assessment
• They report sensitivity or allergies to propranolol, or a history of PTSD exacerbation with prior propranolol therapy
• 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
• 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 followup).
• Open-heart surgery and intracranial surgery

Sponsors & Collaborators

• University of California, San Francisco: lead
• United States Department of Defense: collaborator
• Northern California Institute of Research and Education: collaborator

Study Sites (1)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Propranolol; propranolol CR

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Marek Brzezinski, M.D., Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2012
• First Posted: March 15, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: July 26, 2021

Record last verified: 2021-07

Locations

US (1)