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Clinical Trials/CTRI/2024/02/062467
CTRI/2024/02/062467Not yet recruitingPhase 4

A Comparative Study Of Hyperbaric Levobupivacaine 0.5% With Hyperbaric Bupivacaine 0.5% For Spinal Anaesthesia In Elective Lower Segment Cesarean Section Cases

Dr Madhu S N1 site in 1 country112 target enrollmentStarted: February 12, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
112
Locations
1
Primary Endpoint
To compare the effect of hyperbaric levobupivacaine 0.5% with hyperbaric bupivacaine 0.5% on :

Study Overview

Brief Summary

Studies have been done to compare the charecteristics of both drugs .The results showed that the onset of sensory block and complete motor block was shorter in patients receiving levobupivacaine than bupivacaine.Hemodynamic stability was more with levobupivacaine.The aim of this study is to compare the anaesthetic effect and hemodynamic effects of hyperbaric levobupivacaine 0.5% with  hyperbaric bupivacaine 0.5% when given in subarachnoid block in patients undergoing lower segment cesarean section.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 1.Parturients posted for Elective Cesarean section and who give written informed consent for spinal anaesthesia.
  • 2.Parturients aged between 18 years and 40 years.

Exclusion Criteria

  • 1.Patients refusal to participate in the study.
  • 2.Contraindications to spinal anaesthesia(sepsis, local infections, spinal deformity,coagulopathies).
  • 3.Period of gestation less than 35 weeks and more than 40 weeks.
  • 4.Height less than155cm and more than 175cm.
  • 5.BMI less than 18.5 kg/m2and more than 30 kg/m
  • 6.Parturients with gestational hypertension, cardiovascular disorders and other coexisting systemic disorders.

Outcomes

Primary Outcomes

To compare the effect of hyperbaric levobupivacaine 0.5% with hyperbaric bupivacaine 0.5% on :

Time Frame: and at every 1minute interval for first 3 consecutive minutes followed by 5 minute intervals for the next 15minutes and at 15 minute intervals till the end of the surgery.

Sensory and motor characteristics in subarachnoid block

Time Frame: and at every 1minute interval for first 3 consecutive minutes followed by 5 minute intervals for the next 15minutes and at 15 minute intervals till the end of the surgery.

Secondary Outcomes

  • To compare the effects of the 2 drugs on heart(rate, systolic blood pressure, diastolic blood)

Investigators

Sponsor
Dr Madhu S N
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Madhu S N

Bangalore Medical College and Research Institute

Study Sites (1)

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