Comparision of two commonly used drugs Injection Dexmedetomidine and Injection Fentanyl as adjuvant in Caudal Analgesia for pain relief in Paediatric Cardiac Surgery.

Completed

• Conditions: Atrioventricular septal defect, , (2) ICD-10 Condition: O||Medical and Surgical,

• Registration Number: CTRI/2023/04/051255
• Lead Sponsor: Research cell JNMC Sawangi Wardha

Brief Summary

This study is prospective randomised trial , where two commonly used drugs in regional anaesthesia Injection Fentanyl and Injection Dexmedetomidine are compared in terms of Hemodynamic response and Post operative pain relief in Paediatric Cardiac surgery patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-04
• Study Completion: 2024-06-30
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients with Atrial septal defect or ventricular septal defect undergoing intracardiac repair on Cardiopulmonary bypass Weighing 5-15 kg.

Exclusion Criteria

Patients with multiple cardiac defects, Coagulation abnormalities, Infection at caudal injection site, Any patient receiving sedation Within 24 hours of surgey.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemodynamic response and Postoperative pain	Hemodynamic Baseline and Intraoperative at specific events - After sternotomy, after bypass ,extubation and in ICU after shifting | Pain Score - In ICU for First 8 hours

Secondary Outcome Measures

Name	Time	Method
ICU stay, Time to extubation	Duration of stay in ICU - 48 hours, 72 hours ; Time of extubation 2 hours,4 hours, 6 hours after surgery

Trial Locations

Locations (1)

JNMC & AVBRH Hospital,Sawangi; 🇮🇳 Nagpur, MAHARASHTRA, India

JNMC & AVBRH Hospital,Sawangi

🇮🇳Nagpur, MAHARASHTRA, India

Dr Roshani Manwani

Principal investigator

9962348529

chetwaniroshani@gmail.com