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

General Anesthesia Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06431178
• Other study ID #: 36264MD57/3/23
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Atrial Septal Defect
• Dexmedetomidine
• General Anesthesia
• Heart Septal Defects
• Heart Septal Defects, Atrial
• Ketamine
• Local Infiltration

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