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Spinal anesthesia in neonates and infants

A randomized, double blind, superiority trial comparing hyperbaric bupivacaine and hyperbaric ropivacaine in neonates and infants undergoing infraumbilical surgeries. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088138
Enrollment
50
Registered
2025-06-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: K409- Unilateral inguinal hernia, without obstruction or gangrene

Interventions

Intervention1: hyperbaric ropivacaine: Local anesthetic agent hyperbaric ropivacaine 0.5% will be given intrathecally. Dose= 0.5mg/kg. Intervention duration5-10 minutes Control Intervention1: hyperbar

Sponsors

Sucheta Gore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Parents willing to enroll their children in this study. Age less than or equal to 1 year. Patients undergoing infraumbilical surgeries. ASA grade 1 & 2

Exclusion criteria

Exclusion criteria: Parents not consenting for the procedure. Patients having increased intracranial pressure. Patients having allergy to local anesthetic drugs. Patients having local site infection. Uncorrected hypovolaemia. Coagulation abnormalities. Neurological abnormalities such as spina bifida, meningocele. Patients already on mechanical ventilation.

Design outcomes

Primary

MeasureTime frame
The primary outcome will be assessing the effectiveness of the anaesthesic drug by comparing the block parameters such as onset, durationTimepoint: 1,5,10,15,20,30,45,60,90 mins

Secondary

MeasureTime frame
Heamodynamic stability: assessing the heart rate , blood pressure, oxygen saturation throughout the procedure. Requirement of rescue analgesia and conversion to GA or mechanical ventilation. Surgeon satisfaction with the depth of anesthesia. Timepoint: 1,5,10,15,20,30,45,60,90 mins for hemodynamic parameters

Countries

India

Contacts

Public ContactDr Bhuvaneshwari Balasubramanian

ALL INDIA INSTITUTE OF MEDICAL SCIENCES , NAGPUR

varadagore1@gmail.com8237838067

Outcome results

None listed

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