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Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization (KETADEX)

29. april 2026 opdateret af: Nguyen Thi Hong Ha, National Children's Hospital, Vietnam

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

150

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Vietnam
      • Hanoi, Vietnam, 10000
        • Rekruttering
        • Vietnam National Children's Hospital
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Pediatric patients undergoing cardiac catheterization at Vietnam National Children's Hospital

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
KETADEX
Pediatric patients undergoing the dexmedetomidine-ketamine spontaneous sedation regimen on cardiac catheterization
Medicin: Spontaneous sedation regimen
Patients who are naturally ventilated, undergo spontaneous sedation regimen including: dexmedetomidine and ketamine.
GA
Pediatric patients undergoing the traditional general anesthesia regimen on cardiac catheterization
Medicin: General anesthesia regimen
Patients who are mechanically ventilated, undergo general anesthesia regimen

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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.
Perioperative/periprocedural

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of respiratory adverse events throughout the duration of the cardiac catheterization procedure
Tidsramme: 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".
Perioperative/periprocedural
Incidence of cardiovascular adverse events throughout the duration of the cardiac catheterization procedure
Tidsramme: 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
Perioperative/periprocedural
Incidence of neurological adverse events throughout the recovery period.
Tidsramme: 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".
Up to 3 hours post-procedural
Incidence of any of the adverse events during the use of the sedation and anesthesia regimen
Tidsramme: 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.
From sedation initiation to the end of the procedure
Incidence of any of the adverse events during the recovery from the procedure
Tidsramme: Up to 3 hours post-procedural
Any of the adverse events during recovery from the procedure.
Up to 3 hours post-procedural

Andre resultatmål

Resultatmål
Tidsramme
Description of the medications used in the sedation or anesthesia regimen
Tidsramme: Perioperative/periprocedural
Perioperative/periprocedural

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Children's Hospital, Vietnam

Efterforskere

  • Ledende efterforsker: Hong Ha Thi Nguyen, PhD., Vietnam National Children's Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. februar 2026

Primær færdiggørelse (Anslået)

30. december 2026

Studieafslutning (Anslået)

30. december 2026

Datoer for studieregistrering

Først indsendt

17. marts 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. marts 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2026S-07

Plan for individuelle deltagerdata (IPD)

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JA

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

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