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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KETADEX | Pediatric patients undergoing the dexmedetomidine-ketamine spontaneous sedation regimen on cardiac catheterization |
| |
| GA | Pediatric patients undergoing the traditional general anesthesia regimen on cardiac catheterization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spontaneous sedation regimen | Drug | Patients who are naturally ventilated, undergo spontaneous sedation regimen including: dexmedetomidine and ketamine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Perioperative/periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Description of the medications used in the sedation or anesthesia regimen | Perioperative/periprocedural |
Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients undergoing cardiac catheterization at Vietnam National Children's Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Ha Thi Nguyen, PhD | Contact | +84904111838 | honghant@nch.gov.vn | |
| Nhat Minh Tran, BPharm, MSc | Contact | +84936110303 | nhatminh@nch.gov.vn |
| Name | Affiliation | Role |
|---|---|---|
| Hong Ha Thi Nguyen, PhD. | National Children's Hospital, Vietnam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vietnam National Children's Hospital | Recruiting | Hanoi | 10000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34884350 | Background | 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. | |
| Background | Hằng, 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 |
| Label | URL |
|---|---|
| Dexmedetomidine-ketamine Combination Versus Fentanyl-midazolam During Bronchoscopy | View source |
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| General anesthesia regimen | Drug | Patients who are mechanically ventilated, undergo general anesthesia regimen |
|
| 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):
| Perioperative/periprocedural |
| Incidence of neurological adverse events throughout the recovery period. | Incidence of neurological adverse events during recovery from the procedure:
| 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. | 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. | Up to 3 hours post-procedural |
| Dexmedetomidine Sedation in Children With Respiratory Morbidities | View source |