Skip to content

Comparative study between two drugs in pediatric spinal anaesthesia

Comparative study between intrathecal Bupivacaine heavy and intrathecal Ropivacaine heavy in pediatric patients undergoing lower limb or lower abdominal surgeries: A Prospective Randomized double blind study - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069068
Enrollment
62
Registered
2024-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Ropivacaine heavy (0.75%) and Fentanyl: intrathecal Ropivacaine with dose 1mg/kg body weight for less than 5kg, 0.5mg/kg body weight for 5-15 kg, 0.5mg/kg body weight for more than 15k

Sponsors

Dr Putul Kumari
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. parents of patients willing to participate 2. ASA garde 1-3 3. schedule for lower extremity or lower abdominal surgery 4. operative procedure requiring spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1. Any contraindication to spinal anaesthesia(bleeding diathesis, infection at local site , congenital spinal anomaly ) 2. patient with developmental delay 3. patient allergic to study drug

Design outcomes

Primary

MeasureTime frame
To Compare the Blockade with Bupivacaine heavy and Ropivacaine heavy that is onset, level, degree and duration of blockTimepoint: In Operation Theatre(zero hours)

Secondary

MeasureTime frame
To Monitor Hemodynamic Parameter(pulse, heart rate, systolic & diastolic blood pressure , mean arterial pressure) side effect that is bradycardia, hypotension, vomiting, respiratory depression, itching, shivering Post Operative Need of Additional AnalgesiaTimepoint: 6 hrs

Countries

India

Contacts

Public ContactDr Bibha Kumari

Indira Gandhi Institute of Medical Sciences

drbibha98aditi@gmail.com8252410069

Outcome results

None listed

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