To compare norepinephrine and phenylephrine infusion to prevent spinal anesthesia induced hypotension

Completed

Conditions: Other complications of spinal andepidural anesthesia during pregnancy,

Registration Number: CTRI/2019/12/022505

Lead Sponsor: Vijayanagar Institute of Medical Sciences

Brief Summary: Hypotension is a common adverse effect observed during caesareandelivery done under sub arachnoid block with incidence being around 71%. Thiscan adversely affect maternal and foetal outcomes in addition to the associatedsequelae such as nausea, vomiting. As a result, prevention of spinalhypotension has for long been a prime research area within the field ofobstetric anaesthesia.

Various methods have been employed to prevent this complication.They include fluid preloading /co-loading and prophylactic use of vasopressors.

Phenylephrine,an alpha agonist is a popular drug for both treatment and prevention of spinalanaesthesia induced hypotension. It reduces the incidence of maternalhypotension with better preservation of other maternal and foetal parameters. Its use is often associated with reflex bradycardia and risk of a reduction inthe cardiac output.

Norepinephrinehas predominantly alpha and weak beta receptor agonism with lesser tendency toreduce heart rate and the cardiac output.

This study is designed to compare the efficacy of prophylacticinfusion of 50 Âµg/min of phenylephrine and 5 Âµg/min of norepinephrine in theprevention of hypotension caused by subarachnoid block in caesarean section.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 190

Inclusion Criteria

1.American Society of Anesthesiologists physical status 2 2.Singleton term pregnancy.

Exclusion Criteria

1.Age less than 18 years 2.Height less than 150cm or more than 180cm 3.Weight less than 50kg or more than 100kg 4.Contraindication to spinal anaesthesia 5.Allergy to drugs used in the study 6.Eclampsia,preeclampsia,placenta previa,diabetes mellitus,hypertension,cardiovascular disease or refusal to be in the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of hypotension	Study parameters are observed and recorded just before spinal anaesthesia and thereafter every minute after spinal anaesthesia until 10 min after baby extraction

Secondary Outcome Measures

Name	Time	Method
Incidence of hypertension, APGAR score of the baby, bradycardia, tachycardia, nausea and vomitting	Study parameters are observed and recorded just before spinal anaesthesia and thereafter every minute after spinal anaesthesia until 10 min after baby extraction

Trial Locations

Locations (1): Vijayanagar Institute of Medical Sciences
🇮🇳
Bellary, KARNATAKA, India
Vijayanagar Institute of Medical Sciences
🇮🇳Bellary, KARNATAKA, India
DrPachha Priya
Principal investigator
9686726117
pachhapriya5@gmail.com