Trial · NCT00480740
The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease
NCT00480740, Phase 3, Completed, Children's National Research Institute; results first posted 2015-06-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease. Trials, record NCT00480740. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00480740
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease
- NCT number
- NCT00480740
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 41 participants, actual
- Lead sponsor
- Children's National Research Institute
- Conditions
- Cardiac Transplant, Patent Ductus Arterious, Atrial Septal Defect, Bidirectional Cavopulmonary Anastomosis
- Interventions
- Dexmedetomidine
- First posted
- 2007-05-31
- Last updated
- 2015-06-26
- Results first posted
- 2015-06-26
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine. | Up to 24 hours following cardiac catheterization | Non-inferiority was shown when differences at steady-state (dexmedetomidine + sevoflurane) compared to baseline (sevoflurane alone) and its associated 95% confidence interval fell completely within the range of plus or minus 20%.The 95% confidence interval was normalized by subtracting the baseline values. Bispectral Index: monitors electroencephalographic and electromyographic parameters to monitor the depth of anesthesia. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine. | Up to 24 hours following cardiac catheterization | percentage of change from baseline | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine. | Normal Physiology | Heart Rate | -0.14 | 95% Confidence Interval -0.15 to -0.13 | percentage of change from baseline |
| Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine. | Cardiac Transplant | Heart Rate | -0.16 | 95% Confidence Interval -0.2 to -0.12 | percentage of change from baseline |
| Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine. | Fontan Physiology | Heart Rate | -0.21 | 95% Confidence Interval -0.22 to -0.2 | percentage of change from baseline |
| Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine. | Normal Physiology | Systolic Pressure | 0.15 | 95% Confidence Interval 0.07 to 0.23 | percentage of change from baseline |
| Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine. | Cardiac Transplant | Systolic Pressure | 0.18 | 95% Confidence Interval 0.08 to 0.28 | percentage of change from baseline |
| Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine. | Fontan Physiology | Systolic Pressure | 0.22 | 95% Confidence Interval 0.16 to 0.28 | percentage of change from baseline |
| Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine. | Normal Physiology | Diastolic Pressure | 0.23 | 95% Confidence Interval 0.13 to 0.36 | percentage of change from baseline |
| Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine. | Cardiac Transplant | Diastolic Pressure | 0.19 | 95% Confidence Interval 0.13 to 0.25 | percentage of change from baseline |
| Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine. | Fontan Physiology | Diastolic Pressure | 0.09 | 95% Confidence Interval -0.11 to 0.29 | percentage of change from baseline |
| Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine. | Normal Physiology | Mean Pressure | 0.23 | 95% Confidence Interval 0.17 to 0.29 | percentage of change from baseline |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Normal Physiology | 26 | |
| Overall Study | STARTED | Cardiac Transplant | 9 | |
| Overall Study | STARTED | Fontan Physiology | 6 | |
| Overall Study | COMPLETED | Normal Physiology | 26 | |
| Overall Study | COMPLETED | Cardiac Transplant | 9 | |
| Overall Study | COMPLETED | Fontan Physiology | 6 | |
| Overall Study | NOT COMPLETED | Normal Physiology | 0 | |
| Overall Study | NOT COMPLETED | Cardiac Transplant | 0 | |
| Overall Study | NOT COMPLETED | Fontan Physiology | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cardiac Transplant | ||
| Total, all-cause mortality | Fontan Procedure | ||
| Total, all-cause mortality | Normal Physiology | ||
| Total, other adverse events | Cardiac Transplant | 0 | 9 |
| Total, other adverse events | Fontan Procedure | 0 | 6 |
| Total, other adverse events | Normal Physiology | 0 | 26 |
| Total, serious adverse events | Cardiac Transplant | 0 | 9 |
| Total, serious adverse events | Fontan Procedure | 0 | 6 |
| Total, serious adverse events | Normal Physiology | 0 | 26 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00480740
GET https://conductscience.org/api/trials/v1/NCT00480740/registered