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

Phase 4

Not yet recruiting

Conditions: Maternal care for other malpresentation of fetus,

Registration Number: CTRI/2025/03/082794

Lead Sponsor: Dr nisha george

Brief Summary: A Double blinded randomized control trial to compare the hemodynamics and vasopressor requirement by using two local anesthetic agents 0.75% ropivacaine with 0.5% bupivacaine in patients undergoing elective cesarean section under spinal anesthesia anf to see the onset and level of motor and sensory blockade .

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 90

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the vasopressor requirement in treating spinal anesthesia induced hypotension among Hyperbaric Ropivacaine with Hyperbaric Bupivacaine groups	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 Outcome Measures

Name	Time	Method
time of onset at peak level of sensory blockade duration of sensory blockonet of motor blockadverse efvents like nausea vomitting respiratory depression shivering	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

Trial Locations

Locations (1): Karnataka Institute of Medical Sciences
🇮🇳
Dharwad, KARNATAKA, India
Karnataka Institute of Medical Sciences
🇮🇳Dharwad, KARNATAKA, India
Dr Nisha George
Principal investigator
7022135720
nishatheresa31@gmail.com