Comparison of two drugs Norepinephrine and Phenylephrine used for the treatment of fall in blood pressure after spinal anaesthesia for Caeserean delivery of uncomplicated pregnancy
- Conditions
- Encounter for cesarean delivery without indication, (2) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,
- Registration Number
- CTRI/2018/08/015364
- Lead Sponsor
- amrita institue of medical sciences
- Brief Summary
Background and Aims: Hypotension following spinal anaesthesia for caesarean section is
common in spite of adequate fluid loading. Phenylephrine is the recommended drug to treat spinal
hypotension during caesarean section. Recently, norepinephrine boluses are being suggested as
an alternative to phenylephrine boluses. The aim of our study was to compare the effectiveness
of bolus doses of norepinephrine with phenylephrine to treat spinal hypotension during caesarean
section. Methods: Fifty patients undergoing elective caesarean section under spinal anaesthesia
were randomly assigned into two groups. Group P patients received phenylephrine 50 μg as an
intravenous bolus and group N received 4 μg of norepinephrine as intravenous bolus to treat
spinal hypotension. The primary objective of our study was to compare the number of bolus
doses of norepinephrine or phenylephrine required to treat spinal hypotension. The secondary
objectives were to compare the incidence of bradycardia, hypertension, nausea and vomiting in
mother and foetal outcomes. Results: The number of boluses of vasopressors required to treat
hypotension was significantly lower in group N (1.40 ± 0.577 vs. 2.28 ± 1.061, P = 0.001). The
frequency of bradycardia was high in group P, but this difference was not statistically significant
(4%vs. 20%, P = 0.192). Maternal complications such as nausea and vomiting and shivering were
comparable between the groups. The foetal parameters were also comparable between the two
groups. Conclusion: Intermittent boluses of norepinephrine are effective in the management of
spinal‑induced hypotension during caesarean section. The neonatal outcomes were similar in both
the groups. Norepinephrine boluses can be considered as an alternative to phenylephrine boluses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 50
Elective CS under spinal anaesthesia, Normal singleton pregnancy beyond 36 weeks gestation, ASA physical status 1 or 2, Weight 50-100 kg, Height 150-180 cm.
Allergy or hypersensitivity to phenylephrine or norepinephrine, Any hypertensive disorders of pregnancy, Cardiovascular or cerebrovascular disease, Fetal abnormalities.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare number of boluses of norepinephrine vs. phenylephrine required to maintain maternal blood pressure when used to treat post-spinal hypotension in patients undergoing caesarean section. end of surgery
- Secondary Outcome Measures
Name Time Method To compare the effects of these two drugs on incidence of bradycardia, hypertension, nausea& vomiting in mother and foetal outcomes such as APGAR score & umbilical vein blood gases. end of surgery
Trial Locations
- Locations (1)
Amrita institute of medical sciences
🇮🇳Ernakulam, KERALA, India
Amrita institute of medical sciences🇮🇳Ernakulam, KERALA, IndiaNitu PuthenveettilPrincipal investigator9495962020nituveesundeep@gmail.com