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
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Aya Ebrahim Abdelhafez Mashal | Tanta | El-Gharbia Governorate, Egypt |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
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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