Comparison of two medicines, Phenylephrine and Norepinephrine for managing low blood pressure occurring after spinal anaesthesia inÂ planned caesarianÂ cases.

Phase 3

Recruiting

Conditions: Encounter for cesarean delivery without indication,

Registration Number: CTRI/2023/07/055646

Lead Sponsor: Dr Hariharan Kannan

Brief Summary: *Background:* Post-spinal hypotension is a common complication with incidence as high as 30-90%. This may lead to adverse maternal and foetal outcomes such as nausea, emesis, light headedness, impair uterine and intervillous blood flow, and result in foetal acidosis and neonatal depression. The aim of this study is to compare bolus doses of Phenylephrine and Norepinephrine for treating hypotension in mothers undergoing elective caesarean section under spinal anaesthesia.

*Methods:* Eight-six pregnant mothers with singleton pregnancy posted for caesarean section will be randomly assigned to either Phenylephrine group or a Norepinephrine group. An assessor blind to group allocation will measure umbilical artery pH obtained from blood samples sent for blood gas analysis from a segment of umbilical cord double clamped before the babyâ€™s first breath, Apgar scores at 1 min and 5 min, birth weight, the number of hypotensive episodes, vasopressor requirements, the incidence of tachycardia/bradycardia/ arrhythmias/hypertension and maternal complications such as nausea and vomiting, and shivering. It is hypothesized that Phenylephrine has better neonatal and maternal outcomes, and has better efficacy in treating hypotension when compared to Norepinephrine.

*Discussion:* If the study proves that Norepinephrine is more beneficial vis-a-vis Phenylephrine as vasopressor to maintain blood pressure and cardiac output following spinal anaesthesia, it could lead to increased use of Norepinephrine with benefits to neonatal outcomes and better maternal haemodynamic control.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 86

Inclusion Criteria

Mothers with singleton term pregnancy undergoing elective caesarean section under spinal anaesthesia.

Exclusion Criteria

Mothers with complications such as 1.
Hypertensive disorders complicating pregnancy 2.
Other cardiovascular/cerebrovascular disease, peripheral vascular thrombosis 3.
Contra-indications for spinal anaesthesia 4.
Multiple pregnancy 5.
Known foetal abnormality 6.
And those receiving monoamine oxidase inhibitors or tricyclic antidepressants.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umbilical artery pH	At delivery of baby

Secondary Outcome Measures

Name	Time	Method
Maternal haemodynamic parameters such as Heart rate, Blood Pressure, Arrythmias	End of surgery
APGAR Score	1 min & 5 min following delivery
Maternal morbidity such as nausea, vomitin, shivering	End of Surgery

Trial Locations

Locations (1): KMCH Institue of Health Sciences and Research
🇮🇳
Coimbatore, TAMIL NADU, India
KMCH Institue of Health Sciences and Research
🇮🇳Coimbatore, TAMIL NADU, India
Dr Hariharan Kannan
Principal investigator
8105564983
dr.hariharankannan@gmail.com