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NCT Number: NCT06431178

General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients

The aim of the present study is to compare between general anesthesia versus sedation with dexmedetomidine and ketamine with local infilteration at the catheter insertion site in pediatric patients undergoing transcutaneous closure of atrial septal defect on hemodynamic changes.

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Key information

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aya Ebrahim Abdelhafez Mashal

Tanta, El-Gharbia Governorate, Egypt, 31527, Egypt

About this study

Atrial septal defect (ASD) is one of the most common types of congenital heart defects, occurring in about 25% of children General anaesthesia is usually obtained with tracheal intubation and mechanical ventilation or spontaneous breathing, the depth of anesthesia required to tolerate the presence of a tracheal tube will invariably lead to some reduction in myocardial contractility and alteration of respiratory mechanics. The goal of anesthetic technique is to provide sedation and analgesia during cardiac catheterization to ensure immobility and hemodynamic stability.

Ketamine is an N-methyl-D-aspartate receptor (NMDA) antagonist with sedative, analgesic, and sympathomimetic effects. Among its benefits ,it has the ability to protect airway reflexes with minimal effect on ventilatory drive.

Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist with sedative, anxiolytic, and analgesic effect, it also blunts the sympathetic nervous system response to surgical stimulation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 3-8 years old.
  • Both genders.
  • American Society of Anesthesiologists (ASA) physical status II-III
  • Pediatric patients scheduled for elective transcatheter atrial septal defect closure.

Exclusion criteria

  • Patients with multiple congenital anomalies.
  • Patients with congestive heart failure
  • Patients with Organ dysfunction liver or renal disease or pulmonary disease.
  • Recent chest infection.
  • Airway abnormalities.

Treatment and study plan

General anesthesia

Other

General anesthesia will be induced by 6% sevoflurane with a face mask. An intravenous line(22-g cannula )will be inserted then fentanyl 1mcg-kg will be given . Endotracheal tube will be used to intubate the patient .Anesthesia will be maintained by 2%sevoflurane inhalation in an oxygen air compination 1:1 throught the operation . Crystalloid solution was used to replenish fluid according "4/2/1-rule". Monitoring during the procedure include , ejection fraction (EF),blood pressure, heart rate, respiratory rate, and O2 saturation are measured at baseline, after induction, 10 min after catheter insertion,30 min during procedure and post emergence.

Local anesthesia

Other

A nasal cannula was placed and oxygen delivered at 2 to 3 L/minute. An intravenous line will be inserted (22-g cannula). The sedation regimen will include loading dose of dexmedetomidine (1 mcg/kg) and ketamine (1mg/kg) over 10 minutes . The patient will receive an infusion of dexmedetomidine at 0.7 mcg/kg per hour and ketamine 0.5 mg/kg/hr as maintenance sedation .Local infilteration of xylocaine 2% at dose 2mg/kg will be given for vascular access in cardiac catheterization . After completion of the procedure the infusion pump will be stopped to ensure that the patient is fully awake and vitally stable

Primary outcomes

  1. Heart rate

    Time frame: Immediately after the intervention

    Heart rate will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups.

Secondary outcomes

  1. Mean arterial blood pressure

    Time frame: Immediately after the intervention

    Mean arterial blood pressure will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups.

  2. O2 saturation

    Time frame: Immediately after the intervention

    O2 saturation will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups.

  3. Respiratory rate

    Time frame: Immediately after the intervention

    Respiratory rate will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups.

  4. Lengh of hospital stay

    Time frame: 28 days postoperative

    Length of hospital stay will be measured from admission till discharge from hospital

  5. Recovery time

    Time frame: Immediately after discharge from post-anesthesia care unit

    Recovery time will be measured from the end of surgery till discharge from post-anesthesia care unit (PACU).

  6. Complications

    Time frame: 24 hours postoperative

    Postoperative complications such as arrythmia, hypotension, bradycardia, nausea and vomiting will be measured.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

A Comparative Study Between General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 28, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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