Prospective Randomized double blind comparitive study between the efficacy of intrathecal 0.5 percent Bupivacaine heavy vs isobaric in elective lscs.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- To compare the anaesthetic properties of isobaric and hyperbaric
Study Overview
Brief Summary
Elective lower segment cesarian section is a commonly performed surgical procedure which requires anaesthesia. Most common mode of anaesthesia used is spinal anaesthesia . The drug commonly used to give spinal anaesthesia in such patients is injection bupivacaine 0.5 percent hyperbaric. This study aims to compare the anaesthetic properties and haemodynamic changes caused by the aforementioned drug to isobaric injection bupivacaine 0.5 and its anaesthetic properties and haemodynamic changes.
Inclusion criteria includes patients undergoing elective cesarian section between the ages of 20 and 40. ASA 2. Height more than 150 cms and gestational age of greater than 35 weeks.
Similarly exclusion criteria involves patients undergoing emergency lower section cesarean section , contraindication or allergy to the above used drugs, contraindication to spinal anaesthesia, patient refusal.
The study will be conducted in dy patil school of medicine and hospital, nerul, navi mumbai. Over a period of 2 years.
The study method is randomised control trial double blind.
Sample size is 48.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1 All patients giving consent undergoing elective lscs 2 ASA grade 2 3 patients coming for elective c-section with gestational age og greater than 35 weeks 4 height more than 150 cms.
Exclusion Criteria
- •Patients undergoing emergency C-SECTIONS 1 Patients known or suspected to have allergy for study drugs.
- •2 Patient refusal 3 Patients with contraindications to spinal anaesthesia.
Outcomes
Primary Outcomes
To compare the anaesthetic properties of isobaric and hyperbaric
Time Frame: at base line,2 mins,4 mins, 6 mins, 8 mins, 15 mins, 20 mins, 25 mins, 30 mins, 40 mins, 50 mins, 60 mins
bupivacaine in spinal anaesthesia, which includes the time of onset of sensory
Time Frame: at base line,2 mins,4 mins, 6 mins, 8 mins, 15 mins, 20 mins, 25 mins, 30 mins, 40 mins, 50 mins, 60 mins
and motor block and duration of block obtained (both sensory and motor)
Time Frame: at base line,2 mins,4 mins, 6 mins, 8 mins, 15 mins, 20 mins, 25 mins, 30 mins, 40 mins, 50 mins, 60 mins
Secondary Outcomes
- To compare the effects of both the drugs on haemodynamic(parameters which include heart rate & blood pressure & side effects.)
Investigators
Dr kaushik dandanak
D.Y Patil school of medicine