Depression Clinical Trial
Official title:
Preventing Post-Operative Delirium in Pneumonectomy, Esophagectomy and Thoracotomy Patients
The purpose of this study is to investigate the effectiveness of a preventative low-dose of
Haloperidol to prevent delirium in patients undergoing a esophagectomy, pneumonectomy or
thoracotomy.
Delirium is state of severe confusion and some symptoms include:
- Cannot think clearly
- Have trouble paying attention
- Have a hard time understanding what is going on around them
- May see or hear things that are not there. These things seem very real to them.
50% of patients who undergo esophageal and/or lung resection suffer from acute brain
dysfunction or delirium postoperatively. Delirium is a state of brain failure characterized
by disturbance of consciousness with reduced ability to focus, sustain, or shift attention
that occurs over a short period of time and tends to fluctuate over the course of the day.
Presence of delirium in the post-operative phase is associated with a longer length of both
intensive care unit and hospital stay, increased health-care costs, long-term functional and
cognitive decline, and an increased risk of in-hospital and post-discharge mortality.
Haloperidol primarily acts by blocking dopamine (D2) receptors. This dopamine blockade in
the cerebral cortex improves cognition and reduces delirium. Along with the dopamine
blockade, haloperidol has anti-inflammatory properties. It inhibits production of
lipopolysaccharide induced pro-inflammatory cytokines, interleukin (IL-1) and tumor necrosis
factor alpha (TNF-α). Haloperidol also increases levels of Interleukin -1 receptor
antagonist (IL-1RA), an anti-inflammatory cytokine that blocks the action of other
pro-inflammatory cytokines. If unchecked, the inflammatory cytokines cause impaired
concentration, sleep disturbances, and agitation the cardinal symptoms of delirium; and
induce a reduction in cholinergic activity. Given the inhibitory effect of acetylcholine on
certain cytokines such as interleukin-6, a repetitive cycle of inadequate regulation of
inflammation due to cholinergic depletion ensues. Haloperidol with its anti-inflammatory
properties seeks to mitigate this repetitive vicious cycle.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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