Comparision of two drugs named Phenylephrine and Norepinephrine to decrease the occurance of low blood pressure after spinal anaesthesia in cesarean deliveries.
- Conditions
- Sequelae of complication of pregnancy, childbirth, and the puerperium,
- Registration Number
- CTRI/2020/09/027704
- Lead Sponsor
- Pramukh Swami Medical College and Shree Krishna Hospital and Research Center
- Brief Summary
Hypotension is a very common consequence of the sympathetic vasomotor block caused by spinal anaesthesia for cesarean section. Severe hypotension in obstetrics patient will lead to decreased oragn perfusion, dyspnoea, nausea, vomiting in the mother and depressed APGAR score and fetal acidosis in the fetus. The measures in the form of positioning to prevent aortocaval compression and pre or co loading of crystelloids have not been proven to completely prevent post spinal hypotension. Vasopressors like ephedrine and phenylephrine are being used routinely nowadays to prevent or treat post spinal hypotension in addition to above mentioned measures. Both vasopressors have their own pros and cons and various studies have been done to check their efficacy and safety profile. Phenylephrine is the preffered agent as per the literatures available. Norepinephrine has been found to have better profile as a vasopressor theoritically. There are on;y few studies to support this. So we planned to do comparative study of effects of npth drugs by intravenous infusion on feto-metarnal outcomes ny preventing and treating post spinal hypotension in cesarean sections.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 70
All pregnant patients undergoing elective and emergency cesarian who have been given consent for American Society of Anesthesiologists grade 2 and 3 and do not have contraindication to any of the drugs to be studied.
1)Pregnant females with gestational age of less than 36 weeks 2)Known co-morbidities such as severe pregnancy induced hypertension, Diabetes Mellitus, cardiac diseases, epilepsy, eclampsia 3)Patient refusing for spinal anaesthesia 4)contraindication for spinal anaesthesia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Systolic blood pressure different hemodynaemic and vital parameters at different point of time after spinal anaesthesia | 1)baseline | 2)at 2 minutes | 3)at 4 minutes | 4)at 6 minutes | 5)at 8 minutes | 6)at 10 minutes | 7)at 15 minutes | 8)at 20 minutes | 10)at 30 minutes | 11)at 45 minutes | 12)at 60 minutes 3)Mean arterial pressure different hemodynaemic and vital parameters at different point of time after spinal anaesthesia | 1)baseline | 2)at 2 minutes | 3)at 4 minutes | 4)at 6 minutes | 5)at 8 minutes | 6)at 10 minutes | 7)at 15 minutes | 8)at 20 minutes | 10)at 30 minutes | 11)at 45 minutes | 12)at 60 minutes 4)Heart rate different hemodynaemic and vital parameters at different point of time after spinal anaesthesia | 1)baseline | 2)at 2 minutes | 3)at 4 minutes | 4)at 6 minutes | 5)at 8 minutes | 6)at 10 minutes | 7)at 15 minutes | 8)at 20 minutes | 10)at 30 minutes | 11)at 45 minutes | 12)at 60 minutes 2)Diastolic blood pressure different hemodynaemic and vital parameters at different point of time after spinal anaesthesia | 1)baseline | 2)at 2 minutes | 3)at 4 minutes | 4)at 6 minutes | 5)at 8 minutes | 6)at 10 minutes | 7)at 15 minutes | 8)at 20 minutes | 10)at 30 minutes | 11)at 45 minutes | 12)at 60 minutes
- Secondary Outcome Measures
Name Time Method occurance of materal nausea and vomiting at any given time APGAR score at 1 minute and 5 minutes
Trial Locations
- Locations (1)
Shree Krishna Hospital and Research Center
🇮🇳Anand, GUJARAT, India
Shree Krishna Hospital and Research Center🇮🇳Anand, GUJARAT, IndiaDr Madhavi ChaudhariPrincipal investigator9427084963madhavic@charutarhealth.org