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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 8
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Aya Ebrahim Abdelhafez Mashal
RECRUITING
Tanta
Contact Information
Primary
Aya E Mashal, Master
ayaebrahim406@gmail.com
00201009167298
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2025-05-01
Participants
Target number of participants: 60
Treatments
Active_comparator: 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.
Experimental: 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
Related Therapeutic Areas
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov