Back to resultsPerioperative Propranolol in Patients With Post Traumatic Stress Disorder (PTSD)
Primary Purpose
Post-traumatic Stress Disorder
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Propranolol Hydrochloride
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Post-traumatic Stress Disorder focused on measuring Post-traumatic stress disorder, Propranolol, surgery, anesthesia
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
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
- 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
- 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
Sites / Locations
- San Francisco VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Propranolol Hydrochloride
Placebo Group
Arm Description
Outcomes
Primary Outcome Measures
ICU length of stay
Measured using patient medical records
Hospital length of stay
Measured using patient medical records
Postoperative delirium
Measured using Confusion Assessment Method (CAM-CAM-ICU)
Postoperative renal dysfunction
Measured using Serum Creatinine laboratory values
Secondary Outcome Measures
Perioperative complications
Measured using patient medical records
Pain intensity
Measured using the Numerical Rating Scale
Pain unpleasantness
Measured using the Numerical Rating Scale
Analgesics use
Measured using patient medical records
Length of intubation and mechanical ventilation
Measured using patient medical records
Post Traumatic Stress Disorder symptomatology
Measured using the Posttraumatic Diagnostic Scale (PDS)
Quality of Life
Measured using Short Form-36 Questionnaire (SF-36)
Functional status
Measured using Short Form-36 Questionnaire (SF-36)
Sleep Quality
Measured using the Pittsburgh Sleep Quality Index (PSQI)
Depression symptoms
Measured using the Beck Depression Inventory (BDI)
Postoperative Neurocognitive Dysfunction Score
Measured using the Mini Mental State Examination (MMSE)
30-day, 3-month, and 1-year mortality
Measured using patient medical records
Postoperative complications
Measured using patient medical records
Full Information
NCT ID
NCT01555554
First Posted
March 5, 2012
Last Updated
July 22, 2021
Sponsor
University of California, San Francisco
Collaborators
United States Department of Defense, Northern California Institute of Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT01555554
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Unable to meet enrollment goals.
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
United States Department of Defense, Northern California Institute of Research and Education
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
Keywords
Post-traumatic stress disorder, Propranolol, surgery, anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propranolol Hydrochloride
Arm Type
Experimental
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Propranolol Hydrochloride
Other Intervention Name(s)
Inderal, Inderal LA, Avlocardyl, Avlocardyl Retard, Deralin, Dociton, Inderalici, InnoPran XL, Sumial, Anaprilinum, Bedranol SR Sandoz
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
ICU length of stay
Description
Measured using patient medical records
Time Frame
Truncated at 30 days after admission to ICU
Title
Hospital length of stay
Description
Measured using patient medical records
Time Frame
Truncated at 30 days after admission to ICU
Title
Postoperative delirium
Description
Measured using Confusion Assessment Method (CAM-CAM-ICU)
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
Postoperative renal dysfunction
Description
Measured using Serum Creatinine laboratory values
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary Outcome Measure Information:
Title
Perioperative complications
Description
Measured using patient medical records
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
Pain intensity
Description
Measured using the Numerical Rating Scale
Time Frame
Participants will be followed from preoperative baseline to 1 year postoperative
Title
Pain unpleasantness
Description
Measured using the Numerical Rating Scale
Time Frame
Participants will be followed from preoperative baseline to 1 year postoperative
Title
Analgesics use
Description
Measured using patient medical records
Time Frame
Participants will be followed from preoperative baseline to 1 year postoperative
Title
Length of intubation and mechanical ventilation
Description
Measured using patient medical records
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
Post Traumatic Stress Disorder symptomatology
Description
Measured using the Posttraumatic Diagnostic Scale (PDS)
Time Frame
Participants will be followed from preoperative baseline to 1 year postoperative
Title
Quality of Life
Description
Measured using Short Form-36 Questionnaire (SF-36)
Time Frame
Participants will be followed from preoperative baseline to 1 year postoperative
Title
Functional status
Description
Measured using Short Form-36 Questionnaire (SF-36)
Time Frame
Participants will be followed from preoperative baseline to 1 year postoperative
Title
Sleep Quality
Description
Measured using the Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Participants will be followed from preoperative baseline to 1 year postoperative
Title
Depression symptoms
Description
Measured using the Beck Depression Inventory (BDI)
Time Frame
Participants will be followed from preoperative baseline to 1 year postoperative
Title
Postoperative Neurocognitive Dysfunction Score
Description
Measured using the Mini Mental State Examination (MMSE)
Time Frame
Participants will be followed from preoperative baseline to 1 year postoperative
Title
30-day, 3-month, and 1-year mortality
Description
Measured using patient medical records
Time Frame
Participants will be followed from preoperative baseline to 1 year postoperative
Title
Postoperative complications
Description
Measured using patient medical records
Time Frame
Participants will be followed to 1 year postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marek Brzezinski, M.D., Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco VA Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Perioperative Propranolol in Patients With Post Traumatic Stress Disorder (PTSD)
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