Sedation and AnalgesiaPhase 1NCT07669012
a Comparive Study of Ketamine-Propofol Versus Dexmedetomidine-Propofol Sedation in Pediatric Patients Undergoing Cardiac Catheterization for Device Closure of Simple Left-to-right Shunts
A Phase 1 study testing Ketamine + propofol and Dexmedetomidine + propofol in people with Sedation and Analgesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims To compare the safety and efficacy of ketamine-propofol versus dexmedetomidine-propofol sedation in pediatric patients undergoing cardiac catheterization for device closure of simple left-to-right shunts Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Sedation and Analgesia
- What is being tested?
- Ketamine + propofol and Dexmedetomidine + propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Oct 2025to 15 Feb 2027
- Phase
- Phase 1
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 2-12 years, male or female
- Weight ≥ 10 kg
- Scheduled for elective transcatheter device closure of a simple left-to-right shunt, including:
- Secundum atrial septal defect (ASD) suitable for device closure
- Small muscular ventricular septal defect (VSD) eligible for percutaneous device closure
- Patent ductus arteriosus (PDA) closure
Show all 9Show fewer
- Procedure performed with transthoracic or transesophageal echocardiographic guidance according to the cardiology team's practice
- ASA physical status II-III
- Written informed consent obtained from a parent or legal guardian
Who cannot join
- Cyanotic congenital heart disease
- Complex congenital cardiac lesions
- Risk of pulmonary hypertensive crisis
- Requirement for general anesthesia and cuffed endotracheal tube at the discretion of the cardiology or anesthesia team
- Baseline oxygen requirement > 2 L/min
- Use of noninvasive ventilation
Show all 22Show fewer
- Known allergy or intolerance to ketamine, dexmedetomidine, or propofol
- Significant hepatic impairment
- Significant renal impairment
- Advanced atrioventricular block
- Clinically significant bradyarrhythmia
- Uncontrolled epilepsy
- Raised intracranial pressure
- Severe obstructive sleep apnea
- Craniofacial anomalies associated with anticipated difficult airway management
- BMI > 97th percentile when judged to confer high risk of sedation-related airway obstruction
- Current beta-blocker use
- Current clonidine use
- Acute upper respiratory tract infection within 2 weeks before the procedure
- Emergency or add-on procedures
- Anticipated procedure duration < 20 minutes
- Anticipated procedure duration > 3 hours
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university hospital
Cairo
Noha Tarek Hassan, 01000667030, Noha.Hassan@med.asu.edu.eg
About this study
This study aims To compare the safety and efficacy of ketamine-propofol versus dexmedetomidine-propofol sedation in pediatric patients undergoing cardiac catheterization for device closure of simple left-to-right shunts
- Conditions
- Sedation and Analgesia
- Being tested
- Ketamine + propofol, Dexmedetomidine + propofol
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine + propofolDrug
Also called Sedation
Ketamine IV bolus 1 mg/kg (range commonly 0.5-1.5 mg/kg) administered as an initial bolus to provide analgesia and hemodynamic support; followed by a propofol infusion 100-150 µg/kg/min (titrated to clinical effect).
Rescue propofol boluses 0.5 mg/kg IV may be given for inadequate sedation
Dexmedetomidine + propofolDrug
Also called Sedation
Dexmedetomidine loading dose 1 µg/kg over 10 minutes (range 0.5-1 µg/kg reported) followed by maintenance infusion per clinical need; co-administration of propofol infusion 100-150 µg/kg/min, titrated to the sedation target.
Rescue propofol boluses 0.5 mg/kg IV may be used for breakthrough movement or inadequate sedation
| Study group | Role | What they receive |
|---|---|---|
| Group KP: Ketamine + Propofol. | Active comparator | Group that will receive Propofol and ketamine Receives: Drug: Ketamine + propofol |
| Group DP: Dexmedetomidine + Propofol | Active comparator | Group that will receive Dexmedetomidine and Propofol Receives: Drug: Dexmedetomidine + propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of respiratory complications
Percentage of participants experiencing one or more respiratory complications (apnea, hypoxemia, atelectasis, hypercapnia, or need for advanced airway management) during the study period.
Measured: 2 hours
Secondary outcomes (4)
Mean Heart Rate
Heart rate (bpm) measured during the procedure and recovery period.
Measured: 2 hours
Mean Arterial Pressure
Mean arterial pressure ( mmHg) measured during the procedure and recovery period.
Measured: 2 hours
Recovery time
Time from discontinuation of sedative administration to achievement of discharge readiness based on the institution's recovery criteria.
Measured: 2 hours
Adequate Sedation rate
Percentage of participants achieving the target level of sedation throughout the procedure without requiring a change in the assigned sedation regimen.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start22 Oct 2025
- Primary completion22 Oct 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation and AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669012
- Sponsor's protocol ID
- FMASU MD352/2025
- Status last verified
- May 2026
- First submitted
- 2 May 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Comparive Study of Ketamine-Propofol Versus Dexmedetomidine-Propofol Sedation in Pediatric Patients Undergoing Cardiac Catheterization for Device Closure of Simple Left-to-right Shunts
- ClinicalTrials.gov ID
- NCT07669012
- Acronym / sponsor ID
- FMASU MD352/2025
- Conditions
- Sedation and Analgesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 22 Oct 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 25 Jun 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.
This study aims To compare the safety and efficacy of ketamine-propofol versus dexmedetomidine-propofol sedation in pediatric patients undergoing cardiac catheterization for device closure of simple left-to-right shunts
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group KP: Ketamine + Propofol. | Active comparator | Drug: Ketamine + propofolGroup that will receive Propofol and ketamine |
| Group DP: Dexmedetomidine + Propofol | Active comparator | Drug: Dexmedetomidine + propofolGroup that will receive Dexmedetomidine and Propofol |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Age 2-12 years, male or female
- Weight ≥ 10 kg
- Scheduled for elective transcatheter device closure of a simple left-to-right shunt, including:
- Secundum atrial septal defect (ASD) suitable for device closure
- Small muscular ventricular septal defect (VSD) eligible for percutaneous device closure
Key exclusion criteria (22 listed)
- Cyanotic congenital heart disease
- Complex congenital cardiac lesions
- Risk of pulmonary hypertensive crisis
- Requirement for general anesthesia and cuffed endotracheal tube at the discretion of the cardiology or anesthesia team
- Baseline oxygen requirement > 2 L/min
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 |
|---|---|---|
| Ketamine + propofolAlso: SedationKetamine IV bolus 1 mg/kg (range commonly 0.5-1.5 mg/kg) administered as an initial bolus to provide analgesia and hemodynamic support; followed by a propofol infusion 100-150 µg/kg/min (titrated to clinical effect). Rescue propofol boluses 0.5 mg/kg IV may be given for inadequate sedation | Drug | Group KP: Ketamine + Propofol. |
| Dexmedetomidine + propofolAlso: SedationDexmedetomidine loading dose 1 µg/kg over 10 minutes (range 0.5-1 µg/kg reported) followed by maintenance infusion per clinical need; co-administration of propofol infusion 100-150 µg/kg/min, titrated to the sedation target. Rescue propofol boluses 0.5 mg/kg IV may be used for breakthrough movement or inadequate sedation | Drug | Group DP: Dexmedetomidine + Propofol |
Primary outcome
Incidence of respiratory complications
Time frame: 2 hours
Percentage of participants experiencing one or more respiratory complications (apnea, hypoxemia, atelectasis, hypercapnia, or need for advanced airway management) during the study period.
4 secondary outcomes
Mean Heart Rate
Time frame: 2 hours
Mean Arterial Pressure
Time frame: 2 hours
Recovery time
Time frame: 2 hours
Adequate Sedation rate
Time frame: 2 hours
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 25 Jun 2026.
Related trials for Sedation and Analgesia
RecruitingObservational study
Effect of Ketamine on Optic Nerve Sheath Diameter During Procedural Analgesia
Procedural Pain, Procedural Sedation and Analgesia
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
Not yet recruiting
Testing the Timing and Application of Virtual Reality Distraction During Knee Injections in a VA Pain Clinic
Pain Management, Injection Pain Prevention
Enrolling by invitationObservational study
A Prospective Multicenter Registry Study of Sedation and Analgesia in Critically Ill Patients
Sedation, Analgesia Assessment
Not yet recruitingPhase 1
Magnesium Sulfate in Pediatric Burn Dressing Changes
Pediatric Burns
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine + propofol and Dexmedetomidine + propofol in people with Sedation and Analgesia, run by Ain Shams University at 1 site in Egypt.
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 9 inclusion and 22 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 25 Jun 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 Egypt. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of respiratory complications (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2026.