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

KETADEX

Pediatric patients undergoing the dexmedetomidine-ketamine spontaneous sedation regimen on cardiac catheterization

Droga: 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

Droga: General anesthesia regimen

Patients who are mechanically ventilated, undergo general anesthesia regimen

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.

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".

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

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".

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.

Incidence of any of the adverse events during the recovery from the procedure

Any of the adverse events during recovery from the procedure.

Description of the medications used in the sedation or anesthesia regimen