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Comparison between the use of opioid (fentanyl) versus use of non opioid (caudal block with bupivacaine) anaesthesia in neonates undergoing infra umbilical surgeries to determine which technique is better in terms of faster extubation and the degree of analgesia produced

Comparing Opioid Versus Non-Opioid Anaesthesia Technique For Extubation Time In Neonates Undergoing Infraumbilical Surgeries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/045085
Enrollment
40
Registered
2022-08-30
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Opioid Anesthesia Technique: After the baby is shifted to warm operation theatre non-invasive monitoring including electrocardiography, non-invasive blood pressure and pulse oximetry wi

Sponsors

Dr Abhinav Siroha
Lead Sponsor
VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: NEONATES UNDERGOING INFRAUMBILICAL SURGERIES

Exclusion criteria

Exclusion criteria: 1. NEONATES WITH CONGENITAL ABNORMALITY 2.ALREADY INTUBATED NEONATE ON VENTILATORY SUPPORT 3.CONTRAINDICATIONS TO CAUDAL BLOCK

Design outcomes

Primary

MeasureTime frame
TO COMAPARE EXTUBATION TIME BY USING OPIOID AND NON-OPIOID TECHNIQUE FOR ANAESTHESIA IN NEONATES UNDERGOING INFRAUMBILICAL SURGERIESTimepoint: OUTCOME (EXTUBATION TIME) WOULD BE ASSESSED WHEN LAST SKIN SUTURE OF THE ONGOING SURGERY IS PLACED TO THE RETURN OF PROTECTIVE AIRWAY REFLEXES (GAG REFLEX) AND SPONTANEOUS BREATHING

Secondary

MeasureTime frame
TO ASSESS AND COMPARE THE POST OPERATIVE PAIN SCORES BETWEEN OPIOID AND NON-OPIOID ANESTHESIA TECHNIQUETimepoint: Pain will be assessed using Neonatal Infant Pain Scale (NIPS) at 5th minute and later every 15 minutes for the first 1 hour, every 30 mins for next 2 hours and then hourly till total of six hours after extubation.

Countries

India

Contacts

Public ContactDR CHARU BAMBA

VMMC And Safdarjung Hospital

charu.bamba@gmail.com9811270511

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026