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Comparison of drugs given in a single syringe versus that of two separate syringes for lower leg surgeries via spinal injection

Comparison of premixed versus sequential administration of intrathecal hyperbaric bupivacaine and fentanyl in lower abdominal surgeries-A Randomized Control Study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056596
Enrollment
96
Registered
2023-08-17
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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: Premixed Intrathecal hyperbaric bupivacaine (0.5%) and fentanyl: 2.5 ml(12.5mg) of 0.5% hyperbaric bupivacaine and 0.5ml(25mcg) of fentanyl premixed in single syringe and given via spin

Sponsors

Pondicherry Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients belonging to ASA I & II Patient undergoing elective lower abdominal surgeries.

Exclusion criteria

Exclusion criteria: Patients with raised intracranial pressure or any intracranial pathology BMI > 35 Previous Spine surgeries Allergy to local anesthetics. If level of T6 is not achieved Hypovolemia, Bradycardia Patients on anticoagulants Localized infection Pregnant women

Design outcomes

Primary

MeasureTime frame
The time taken for sensory blockade of T6 dermatome. This will be checked from one minute after giving spinal anaesthesia till it attains T6 dermatome level blockade. Timepoint: This outcome of sensory blockade of T6 dermatome level will be assessed from one minute after giving spinal anaesthesia till it attains T6 dermatome level blockade. Rougly 10 minutes

Secondary

MeasureTime frame
â?ª The time taken for the onset of motor blockade (Modified Bromage score-1) â?ª Peak sensory block level. â?ª Hemodynamic parameters like heart rate, systolic & diastolic blood pressure, mean arterial pressure, oxygen saturation will be measured. â?ª To assess the time taken for two segment regression. â?ª To assess time taken for first rescue analgesiaTimepoint: The data will be collected during intra operative period for the above-mentioned & post operatively for four hours

Countries

India

Contacts

Public ContactKarthikeyan Mohan

Pondicherry Institute of Medical Sciences

siva85dr@gmail.com9944060676

Outcome results

None listed

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