Cardiac Catheterization, Pediatric
Conditions
Keywords
dexmedetomidine, ketamine, spontaneous sedation, general anesthesia, cardiac catheterization
Brief 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. 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.
Interventions
DRUGSpontaneous sedation regimen
Patients who are naturally ventilated, undergo spontaneous sedation regimen including: dexmedetomidine and ketamine.
DRUGGeneral anesthesia regimen
Patients who are mechanically ventilated, undergo general anesthesia regimen
Sponsors
National Children's Hospital, Vietnam
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients under 18 years of age. * Patients indicated for diagnostic or interventional cardiac catheterization.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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". |
| 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 |
| 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". |
| 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. |
| 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. |
Countries
Vietnam
Contacts
CONTACTHong Ha Thi Nguyen, PhD
CONTACTNhat Minh Tran, BPharm, MSc
PRINCIPAL_INVESTIGATORHong Ha Thi Nguyen, PhD.
Vietnam National Children's Hospital
Outcome results
None listed