Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy

NCT02213900 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2017-04-13

Study results available
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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.

Conditions

Interventions

DRUG

Haloperidol

0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days

DRUG

Placebo

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Babar A Khan, MD, MS · Regenstrief Institute, Inc.

  • Kenneth A Kesler, MD · IU School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02213900 on ClinicalTrials.gov