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

NCT06431178 | Completed

• 1 other identifier: 36264MD57/3/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General Anesthesia; Dexmedetomidine; Ketamine; Local Infiltration; Atrial Septal Defect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mean arterial blood pressure

  Immediately after the intervention

• O2 saturation

  Immediately after the intervention

• Respiratory rate

  Immediately after the intervention

• Lengh of hospital stay

  28 days postoperative

• Recovery time

  Immediately after discharge from post-anesthesia care unit

Study Arms (2)

General anesthesia

ACTIVE COMPARATOR

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.

Other: General Anesthesia

Local anesthesia

EXPERIMENTAL

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

Other: Local anesthesia

Interventions

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.

General anesthesia

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

Local anesthesia

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Aya Ebrahim Abdelhafez Mashal

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

Location

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Interventions

Anesthesia, General; Anesthesia, Local

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Anesthesia, Conduction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 28, 2024
• Study Start: May 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)