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A Randomized Double Blinded Trial to compare the Hemodynamics of Hyperbaric Ropivacaine with Bupivacaine in Elective Cesarean under Spinal Anesthesia

A Randomized double blinded trial to compare the hemodynamics of hyperbaric Ropivacaine with hyperbaric Bupivacaine in elective cesarean sections under spinal anesthesia - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082794
Enrollment
90
Registered
2025-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: O328- Maternal care for other malpresentation of fetus

Interventions

Intervention1: Hyperbaric ropivacaine: 0.75 percent 10mg with 10mcg fentanyl intrathecally. Hemodynamics is recorded at 2 mins interval for first 20 mins and 10 mins interval throughout the surgery Co

Sponsors

Dr nisha george
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Participants with uncomplicated term singleton pregnancy undergoing elective cesarean delivery . 2)Participants belonging to American Society Of Anesthesiologist 3)Body weight at the time of delivery between 65kgs and 95kgs 4)Height betweeen 155 and 175 cms 5)Participants giving informed written and valid consent 6)Participants age between 18 and 35 years

Exclusion criteria

Exclusion criteria: 1)Participants having hypertensive disorders of pregnancy and diabetes mellitus 2)Participants with cardiac,Cerebrovascular,renal disorders 3)Participants with oligohydramnios,Intrauterine growth retardartion 4)Participants having hypersensitivity to any of the study drugs 5)Participants with known contraindications to spinal anaesthesia.

Design outcomes

Primary

MeasureTime frame
To compare the vasopressor requirement in treating spinal anesthesia induced hypotension among Hyperbaric Ropivacaine with Hyperbaric Bupivacaine groupsTimepoint: measuring heart rate blood pressure respiratory rate oxygen saturation will be monitored Blood pressure will be recorded at 2 min interval for 20 minutes & 10 minute intervals through out surgery

Secondary

MeasureTime frame
time of onset at peak level of sensory blockade duration of sensory blockonet of motor blockadverse efvents like nausea vomitting respiratory depression shiveringTimepoint: neonatal status will be assessed by APGAR score at 1min & 5 min and VAS Score to assess the intensity of podt operative pain it will be assessed 2 hourly till 8 hours

Countries

India

Contacts

Public ContactDrSushma K S

karnataka institute of medical sciences

dr.sushsam@gmail.com9844310403

Outcome results

None listed

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