Cardiac CatheterizationKETADEXNCT07564531
Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization
An observational study of Cardiac Catheterization and Pediatric, run by National Children's Hospital, Vietnam at 1 site in Vietnam.
Trial summary
The goal of this observational study is to learn if the spontaneous sedation regimen of dexmedetomidine-ketamine (KETADEX) has the comparable efficacy and safety in pediatric cardiac catheterization versus the traditional regimen. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cardiac Catheterization, Pediatric
- What is being tested?
- Spontaneous sedation regimen and General anesthesia regimen
- How many people
- 150 participants
- Where
- 1 siteVietnam
- Study dates
- 4 Feb 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients undergoing cardiac catheterization at Vietnam National Children's Hospital
Who may be able to join
- Patients under 18 years of age.
- Patients indicated for diagnostic or interventional cardiac catheterization.
Who cannot join
- Patients with acute respiratory infections, chromosomal abnormalities, metabolic disorders, or other co-existing medical conditions.
- Arrhythmias, second- or third-degree atrioventricular (AV) block; patients on mechanical ventilation or requiring vasopressors prior to the procedure.
- Known history of allergy or hypersensitivity to dexmedetomidine, ketamine, propofol, midazolam, or sevoflurane.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Vietnam National Children's Hospital
Hanoi, 10000
Hong Ha Thi Nguyen, PhD., +84904111838, honghant@nch.gov.vn
Nhat Minh Tran, BPharm, MSc, +84936110303, nhatminh@nch.gov.vn
About this study
Official title: Evaluation of the Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization at Vietnam National Children's Hospital
The goal of this observational study is to learn if the spontaneous sedation regimen of dexmedetomidine-ketamine (KETADEX) has the comparable efficacy and safety in pediatric cardiac catheterization versus the traditional regimen. The main question it aims to answer is:
Is the combined Dexmedetomidine-Ketamine spontaneous sedation regimen (KETADEX) non-inferior to the traditional general anesthesia regimen in terms of efficacy and safety?
Participants would received either KETADEX regimen or general anesthesia regimen. Research members then observe the catheterization procedure and answer the questionnaire about their efficacy and safety.
- Conditions
- Cardiac Catheterization, Pediatric
- Being tested
- Spontaneous sedation regimen, General anesthesia regimen
- Keywords
- dexmedetomidine, ketamine, spontaneous sedation, general anesthesia, cardiac catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spontaneous sedation regimenDrug
Patients who are naturally ventilated, undergo spontaneous sedation regimen including: dexmedetomidine and ketamine.
General anesthesia regimenDrug
Patients who are mechanically ventilated, undergo general anesthesia regimen
| Study group | Role | What they receive |
|---|---|---|
| KETADEX | Pediatric patients undergoing the dexmedetomidine-ketamine spontaneous sedation regimen on cardiac catheterization Receives: Drug: Spontaneous sedation regimen | |
| GA | Pediatric patients undergoing the traditional general anesthesia regimen on cardiac catheterization Receives: Drug: General anesthesia regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Perioperative/periprocedural
Secondary outcomes (5)
Incidence of respiratory adverse events throughout the duration of the cardiac catheterization procedure
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".
Measured: Perioperative/periprocedural
Incidence of cardiovascular adverse events throughout the duration of the cardiac catheterization procedure
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
Measured: Perioperative/periprocedural
Incidence of neurological adverse events throughout the recovery period.
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".
Measured: Up to 3 hours post-procedural
Incidence of any of the adverse events during the use of the sedation and anesthesia regimen
Any of the respiratory and cardiovascular events during the use of the sedation and anesthesia regimen that are considered not related to pain reaction.
Measured: From sedation initiation to the end of the procedure
Incidence of any of the adverse events during the recovery from the procedure
Any of the adverse events during recovery from the procedure.
Measured: Up to 3 hours post-procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start4 Feb 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Children's Hospital, Vietnam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Thi Hong Ha, National Children's Hospital, Vietnam
- Investigators
- Hong Ha Thi Nguyen, PhD., Principal investigator, National Children's Hospital, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564531
- Sponsor's protocol ID
- 2026S-07
- Acronym
- KETADEX
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Mikus M, Welchowski T, Schindler E, Schneider M, Mini N, Vergnat M. Sedation versus General Anesthesia for Cardiac Catheterization in Infants: A Retrospective, Monocentric, Cohort Evaluation. J Clin Med. 2021 Nov 30;10(23):5648. doi: 10.3390/jcm10235648.
PubMed 34884350Hằng, N. T. T., Nam, Đỗ V., Hà, N. T. N., Minh, Đỗ T., Trang, H. T. T., Anh, N. T. V., Huệ, V. T. ., Anh, N. N., Phúc, N. X., & Tuyên, H. N. (2024). 1. KẾT HỢP DEXMEDETOMIDINE VÀ KETAMIN ĐỂ AN THẦN TỰ THỞ CHO BỆNH NHÂN NHI ĐANG THỰC HIỆN THÔNG TIM: KẾT QUẢ BAN ĐẦU TẠI BỆNH VIỆN NHI TRUNG ƯƠNG VIỆT NAM. Tạp Chí Y học Cộng đồng, 65(CĐ 9 - Hội Gây mê Hồi sức). https://doi.org/10.52163/yhc.v65iCD9.1506
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization at Vietnam National Children's Hospital
- ClinicalTrials.gov ID
- NCT07564531
- Acronym / sponsor ID
- KETADEX / 2026S-07
- Conditions
- Cardiac Catheterization, Pediatric
- Keywords
- dexmedetomidine, ketamine, spontaneous sedation, general anesthesia, cardiac catheterization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Children's Hospital, VietnamUniversity, hospital or other
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn if the spontaneous sedation regimen of dexmedetomidine-ketamine (KETADEX) has the comparable efficacy and safety in pediatric cardiac catheterization versus the traditional regimen. The main question it aims to answer is:
Is the combined Dexmedetomidine-Ketamine spontaneous sedation regimen (KETADEX) non-inferior to the traditional general anesthesia regimen in terms of efficacy and safety?
Participants would received either KETADEX regimen or general anesthesia regimen. Research members then observe the catheterization procedure and answer the questionnaire about their efficacy and safety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KETADEX | – | Drug: Spontaneous sedation regimenPediatric patients undergoing the dexmedetomidine-ketamine spontaneous sedation regimen on cardiac catheterization |
| GA | – | Drug: General anesthesia regimenPediatric patients undergoing the traditional general anesthesia regimen on cardiac catheterization |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients undergoing cardiac catheterization at Vietnam National Children's Hospital
Key inclusion criteria (2 listed)
- Patients under 18 years of age.
- Patients indicated for diagnostic or interventional cardiac catheterization.
Key exclusion criteria (3 listed)
- Patients with acute respiratory infections, chromosomal abnormalities, metabolic disorders, or other co-existing medical conditions.
- Arrhythmias, second- or third-degree atrioventricular (AV) block; patients on mechanical ventilation or requiring vasopressors prior to the procedure.
- Known history of allergy or hypersensitivity to dexmedetomidine, ketamine, propofol, midazolam, or sevoflurane.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spontaneous sedation regimenPatients who are naturally ventilated, undergo spontaneous sedation regimen including: dexmedetomidine and ketamine. | Drug | KETADEX |
| General anesthesia regimenPatients who are mechanically ventilated, undergo general anesthesia regimen | Drug | GA |
Primary outcome
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.
Time frame: 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.
5 secondary outcomes
Incidence of respiratory adverse events throughout the duration of the cardiac catheterization procedure
Time frame: Perioperative/periprocedural
Incidence of cardiovascular adverse events throughout the duration of the cardiac catheterization procedure
Time frame: Perioperative/periprocedural
Incidence of neurological adverse events throughout the recovery period.
Time frame: Up to 3 hours post-procedural
Incidence of any of the adverse events during the use of the sedation and anesthesia regimen
Time frame: From sedation initiation to the end of the procedure
Incidence of any of the adverse events during the recovery from the procedure
Time frame: Up to 3 hours post-procedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 34884350Mikus M, Welchowski T, Schindler E, Schneider M, Mini N, Vergnat M. Sedation versus General Anesthesia for Cardiac Catheterization in Infants: A Retrospective, Monocentric, Cohort Evaluation. J Clin Med. 2021 Nov 30;10(23):5648. doi: 10.3390/jcm10235648.
- BackgroundHằng, N. T. T., Nam, Đỗ V., Hà, N. T. N., Minh, Đỗ T., Trang, H. T. T., Anh, N. T. V., Huệ, V. T. ., Anh, N. N., Phúc, N. X., & Tuyên, H. N. (2024). 1. KẾT HỢP DEXMEDETOMIDINE VÀ KETAMIN ĐỂ AN THẦN TỰ THỞ CHO BỆNH NHÂN NHI ĐANG THỰC HIỆN THÔNG TIM: KẾT QUẢ BAN ĐẦU TẠI BỆNH VIỆN NHI TRUNG ƯƠNG VIỆT NAM. Tạp Chí Y học Cộng đồng, 65(CĐ 9 - Hội Gây mê Hồi sức). https://doi.org/10.52163/yhc.v65iCD9.1506
- Dexmedetomidine-ketamine Combination Versus Fentanyl-midazolam During BronchoscopyLink provided by the sponsor.
- Dexmedetomidine Sedation in Children With Respiratory MorbiditiesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hong Ha Thi Nguyen, PhD. principal investigator
National Children's Hospital, Vietnam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Catheterization and Pediatric, run by National Children's Hospital, Vietnam at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Ha Thi Nguyen, PhD (+84904111838, honghant@nch.gov.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Perioperative/periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07564531, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.