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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06431178
Other study ID # 36264MD57/3/23
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date May 1, 2025

Study information

Verified date May 2024
Source Tanta University
Contact Aya E Mashal, Master
Phone 00201009167298
Email ayaebrahim406@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date May 1, 2025
Est. primary completion date May 1, 2025
Accepts healthy volunteers No
Gender All
Age group 3 Years to 8 Years
Eligibility 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.

Study Design


Intervention

Other:
General Anesthesia
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
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

Locations

Country Name City State
Egypt Aya Ebrahim Abdelhafez Mashal Tanta El-Gharbia Governorate, Egypt

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Heart rate 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. Immediately after the intervention
Secondary Mean arterial blood pressure 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. Immediately after the intervention
Secondary O2 saturation 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. Immediately after the intervention
Secondary Respiratory rate 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. Immediately after the intervention
Secondary Lengh of hospital stay Length of hospital stay will be measured from admission till discharge from hospital 28 days postoperative
Secondary Recovery time Recovery time will be measured from the end of surgery till discharge from post-anesthesia care unit (PACU). Immediately after discharge from post-anesthesia care unit
Secondary Complications Postoperative complications such as arrythmia, hypotension, bradycardia, nausea and vomiting will be measured. 24 hours postoperative
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