Trial · NCT07564531
Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization
NCT07564531, Recruiting, National Children's Hospital, Vietnam
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization. Trials, record NCT07564531. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07564531
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization
- NCT number
- NCT07564531
- Status
- Recruiting
- Enrollment
- 150 participants, estimated
- Lead sponsor
- National Children's Hospital, Vietnam
- Conditions
- Cardiac Catheterization, Pediatric
- Interventions
- Spontaneous sedation regimen, General anesthesia regimen
- First posted
- 2026-05-04
- Last updated
- 2026-05-04
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The rate of achieving Ramsay Sedation Scale score 6 without the need for rescue anesthesia and the occurrence of any adverse events throughout the duration of the cardiac catheterization procedure. | Perioperative/periprocedural | The primary endpoint is the rate of achieving the sedation target, which is Ramsay Sedation Scale score of 6, without the need for rescue anesthesia and without any adverse events in cardiovascular, respiratory, or neurological systems occurred during the anesthesia/sedation induction, cardiac catheterization, and recovery periods. |
| Secondary | Incidence of respiratory adverse events throughout the duration of the cardiac catheterization procedure | Perioperative/periprocedural | Incidence of respiratory adverse events throughout the cardiac catheterization procedure (sedation/anesthesia induction, cardiac catheterization, and recovery periods) including: * Oxygen desaturation: SpO2 decreased \> 10% below the lower limit of the normal ranges expressed in percent (%) * Respiratory Rate Change: An increase or decrease in respiratory rate by \> 20% compared to pre-sedation levels. * Increased Lactate: Lactate level \> 2 mmol/L after the procedure (only if lactate level before procedure is ≤ 2 mmol/L), expressed in mmol/L. * Hypercapnia: PaCO2 \> 45 mmHg after the procedure (only if PaCO2 level before procedure is ≤ 45 mmHg), expressed in mmHg. * Increased Secretions: Based on clinical observation throughout the procedure, expressed in "yes" or "no". |
| Secondary | Incidence of cardiovascular adverse events throughout the duration of the cardiac catheterization procedure | Perioperative/periprocedural | Incidence of cardiovascular adverse events throughout the cardiac catheterization procedure (sedation/anesthesia induction, cardiac catheterization, and recovery periods): * The presence of bradycardia: Based on age-adjusted criteria, bradycardia was defined as a HR \<20% below the lower limit of the normal ranges expressed in beats/min * The presence of tachycardia: Based on age-adjusted criteria, tachycardia was defined as a HR \> 20% above the upper limit of the normal ranges expressed in beats/min * The presence of hypertension: Based on age-adjusted criteria hypertension was defined as a MAP \>20% above the upper limit of the normal ranges expressed in mmHg * The presence of hypotension: Based on age-adjusted criteria hypertension was defined as a MAP \<20% below the lower limit of the normal ranges expressed in mmHg |
| Secondary | Incidence of neurological adverse events throughout the recovery period. | Up to 3 hours post-procedural | Incidence of neurological adverse events during recovery from the procedure: * The presence of Nausea and/or Vomiting: defined as the occurrence of nausea and vomitting observed clinically, expressed in "yes" or "no". * The presence of Emergence Agitation and/or Post-Anesthetic Shivering: defined as the occurrence of Emergence Agitation and/or Post-Anesthetic Shivering observed clinically, expressed in "yes" or "no". |
| Secondary | Incidence of any of the adverse events during the use of the sedation and anesthesia regimen | From sedation initiation to the end of the procedure | Any of the respiratory and cardiovascular events during the use of the sedation and anesthesia regimen that are considered not related to pain reaction. |
| Secondary | Incidence of any of the adverse events during the recovery from the procedure | Up to 3 hours post-procedural | Any of the adverse events during recovery from the procedure. |
| Other | Description of the medications used in the sedation or anesthesia regimen | Perioperative/periprocedural |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34884350 | BACKGROUND |
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 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/NCT07564531
GET https://conductscience.org/api/trials/v1/NCT07564531/registered