Trial · NCT02213900
Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy
NCT02213900, Phase 4, Completed, Indiana University; results first posted 2017-04-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy. Trials, record NCT02213900. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02213900
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy
- NCT number
- NCT02213900
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 135 participants, actual
- Lead sponsor
- Indiana University
- Conditions
- Delirium, Cognitive Impairment, Post-traumatic Stress Disorder, Depression, Anxiety
- Interventions
- Haloperidol, Placebo
- First posted
- 2014-08-12
- Last updated
- 2017-04-13
- Results first posted
- 2017-04-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Low-dose Haloperidol in Reducing Delirium Incidence | Up to 30 days | Test the efficacy of low dose haloperidol in reducing delirium incidence among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo. |
| Secondary | Efficacy of Low-dose Haloperidol in Reducing Days With Delirium | Up to 30 days | Test the efficacy of low dose haloperidol in reducing the number of days with delirium among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo. |
| Secondary | Efficacy of Low-dose Haloperidol in Reducing ICU and Hospital Length of Stay | Date of hospital admission through date of hospital discharge, up to 3 weeks on average. | Test the efficacy of low dose haloperidol in reducing ICU and hospital length of stay among patients who are status post esophagectomy or pneumonectomy compared to placebo. |
| Secondary | Efficacy of Low-dose Haloperidol in Reducing Cognitive Impairment at Post-operative Follow-up | Up to 3 months after hospital discharge on average. | Test the efficacy of low dose haloperidol in reducing cognitive impairment at post-operative follow-up among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo. Cognitive status is assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS measures attention, language, visuospatial/constructional abilities, and memory. It is made up of 12 subtests. The subtests produce 5 index scores and a total scale score. All the subtest scores are summed to calculate a Total Index score. The Total Index score is presented. The Total Index score scale is from 0-100 with higher scores indicating less cognitive impairment. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of Low-dose Haloperidol in Reducing Delirium Incidence | Up to 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Efficacy of Low-dose Haloperidol in Reducing Days With Delirium | Up to 30 days | Days with Delirium | MEAN | |
| SECONDARY | Efficacy of Low-dose Haloperidol in Reducing ICU and Hospital Length of Stay | Date of hospital admission through date of hospital discharge, up to 3 weeks on average. | Days | MEAN | |
| SECONDARY | Efficacy of Low-dose Haloperidol in Reducing Cognitive Impairment at Post-operative Follow-up | Up to 3 months after hospital discharge on average. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of Low-dose Haloperidol in Reducing Delirium Incidence | Haloperidol | 15 | Participants | ||
| Efficacy of Low-dose Haloperidol in Reducing Delirium Incidence | Placebo | 19 | Participants | ||
| Efficacy of Low-dose Haloperidol in Reducing Days With Delirium | Haloperidol | 0.3 | Standard Deviation 0.7 | Days with Delirium | |
| Efficacy of Low-dose Haloperidol in Reducing Days With Delirium | Placebo | 0.5 | Standard Deviation 0.9 | Days with Delirium | |
| Efficacy of Low-dose Haloperidol in Reducing ICU and Hospital Length of Stay | Haloperidol | ICU Length of Stay | 2.5 | Standard Deviation 2.2 | Days |
| Efficacy of Low-dose Haloperidol in Reducing ICU and Hospital Length of Stay | Placebo | ICU Length of Stay | 2.8 | Standard Deviation 10.2 | Days |
| Efficacy of Low-dose Haloperidol in Reducing ICU and Hospital Length of Stay | Haloperidol | Overall Length of Stay | 9.3 | Standard Deviation 3.5 | Days |
| Efficacy of Low-dose Haloperidol in Reducing ICU and Hospital Length of Stay | Placebo | Overall Length of Stay | 10.2 | Standard Deviation 4.6 | Days |
| Efficacy of Low-dose Haloperidol in Reducing Cognitive Impairment at Post-operative Follow-up | Haloperidol | Baseline RBANS Total Score | 31.7 | Standard Deviation 27.6 | Units on a scale |
| Efficacy of Low-dose Haloperidol in Reducing Cognitive Impairment at Post-operative Follow-up | Placebo | Baseline RBANS Total Score | 30.1 | Standard Deviation 22.8 | Units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Haloperidol | 68 | |
| Overall Study | STARTED | Placebo | 67 | |
| Overall Study | COMPLETED | Haloperidol | 68 | |
| Overall Study | COMPLETED | Placebo | 67 | |
| Overall Study | NOT COMPLETED | Haloperidol | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Death | General disorders | Haloperidol | 0 | 68 | 0 |
| serious | Death | General disorders | Placebo | 1 | 67 | 1 |
| serious | Life Threatening Episode | General disorders | Haloperidol | 1 | 68 | 1 |
| serious | Life Threatening Episode | General disorders | Placebo | 1 | 67 | 1 |
| serious | Inpatient or Prolonged Current Hospitalization | General disorders | Haloperidol | 2 | 68 | 2 |
| serious | Inpatient or Prolonged Current Hospitalization | General disorders | Placebo | 0 | 67 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Haloperidol | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Haloperidol | 0 | 68 |
| Total, other adverse events | Placebo | 0 | 67 |
| Total, serious adverse events | Haloperidol | 3 | 68 |
| Total, serious adverse events | Placebo | 2 | 67 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30460981 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Haloperidol vs Placebo: Efficacy of Low-dose Haloperidol in Reducing Delirium Incidence | Trial comparisons |
| Haloperidol vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02213900
GET https://conductscience.org/api/trials/v1/NCT02213900/registered