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

Post-traumatic Stress Disorder Clinical Trial

Official title:

Effect of Prophylactic, Perioperative Propranolol on Peri- and Postoperative Complications in Patients With Post Traumatic Stress Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01555554
• Other study ID #: W81XWH-10-2-0078
• Status: Terminated
• Phase: N/A
• Start date: May 2012
• Est. completion date: June 2019

Study information

• Verified date: July 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: June 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Propranolol Hydrochloride
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.

Other:
• Placebo
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.

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Northern California Institute of Research and Education, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU length of stay	Measured using patient medical records	Truncated at 30 days after admission to ICU
Primary	Hospital length of stay	Measured using patient medical records	Truncated at 30 days after admission to ICU
Primary	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
Primary	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	Perioperative complications	Measured using patient medical records	Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary	Pain intensity	Measured using the Numerical Rating Scale	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	Pain unpleasantness	Measured using the Numerical Rating Scale	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	Analgesics use	Measured using patient medical records	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	Length of intubation and mechanical ventilation	Measured using patient medical records	Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary	Post Traumatic Stress Disorder symptomatology	Measured using the Posttraumatic Diagnostic Scale (PDS)	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	Quality of Life	Measured using Short Form-36 Questionnaire (SF-36)	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	Functional status	Measured using Short Form-36 Questionnaire (SF-36)	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	Sleep Quality	Measured using the Pittsburgh Sleep Quality Index (PSQI)	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	Depression symptoms	Measured using the Beck Depression Inventory (BDI)	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	Postoperative Neurocognitive Dysfunction Score	Measured using the Mini Mental State Examination (MMSE)	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	30-day, 3-month, and 1-year mortality	Measured using patient medical records	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	Postoperative complications	Measured using patient medical records	Participants will be followed to 1 year postoperative