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

Not Applicable

Terminated

• Conditions: Post-traumatic Stress Disorder
• Interventions: Other: Placebo; Drug: Propranolol Hydrochloride

• Registration Number: NCT01555554
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-05
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-15
• Study Start: 2012-05
• Primary Completion: 2018-06
• Study Completion: 2019-06
• Status Verified: 2021-07
• Disposition First Submitted: 2021-07-09
• Disposition First Submitted QC: 2021-07-22
• Last Update Submitted: 2021-07-22
• Disposition First Posted: 2021-07-26
• Last Update Posted: 2021-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	-
Propranolol Hydrochloride	Propranolol Hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Hospital length of stay	Truncated at 30 days after admission to ICU	Measured using patient medical records
Postoperative delirium	Participants will be followed for the duration of hospital stay, an expected average of 1 week	Measured using Confusion Assessment Method (CAM-CAM-ICU)
ICU length of stay	Truncated at 30 days after admission to ICU	Measured using patient medical records
Postoperative renal dysfunction	Participants will be followed for the duration of hospital stay, an expected average of 1 week	Measured using Serum Creatinine laboratory values

Secondary Outcome Measures

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

Trial Locations

Locations (1)

San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States