Phase 4
N=135
Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy
Delirium · Cognitive Impairment · Post-traumatic Stress Disorder · Depression · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT02213900 ↗Enrolled (actual)
135
Serious AEs
3.7%
Results posted
Apr 2017
Primary outcome: Primary: Efficacy of Low-dose Haloperidol in Reducing Delirium Incidence — 15; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Haloperidol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Low-dose Haloperidol in Reducing Delirium Incidence |
15; 19 | — |
| SECONDARY Efficacy of Low-dose Haloperidol in Reducing Days With Delirium |
0.3; 0.5 | — |
| SECONDARY Efficacy of Low-dose Haloperidol in Reducing ICU and Hospital Length of Stay |
2.5; 2.8; 9.3; 10.2 | — |
| SECONDARY Efficacy of Low-dose Haloperidol in Reducing Cognitive Impairment at Post-operative Follow-up |
31.7; 30.1; 31.8; 22.7 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- At least ≥ 18 years of age and older
- Undergoing a possible or scheduled thoracotomy
- English speaking
Exclusion Criteria
- History of Schizophrenia and Parkinson's disease
- History of Severe Dementia
- History of Alcohol Abuse
- On Cholinesterase Inhibitors or Levodopa
- Pregnant or Nursing
- Corrected QT interval > 550 milliseconds at the time of randomization
- History of Neuroleptic Malignant Syndrome or Haloperidol Allergy
Data sourced from ClinicalTrials.gov (NCT02213900). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.