A study to compare 2 medications-Phenylephrine and Norepinephrine to prevent fall in blood pressure caused after giving spinal anaesthesia in patients undergoing Caesarean section.

Phase 3

Completed

• Conditions: Other complications of spinal andepidural anesthesia during pregnancy,

• Registration Number: CTRI/2020/03/023761
• Lead Sponsor: AIIMS Raipur

Brief Summary

Hypotensionfollowing spinal anaesthesia during LSCS is a known entity caused due to thesympathetic nerve blockade where hypotension has been described as a fall inSBP to 80% of baseline. Hypotension can cause nausea,vomiting in thepregnant mother and also potentially cause decreased perfusion to the fetus.Vasopressor drugs have become treatment of choice for both prevention andtreatment of hypotension. Ephedrine has been prophylactically used for preventing hypotension utilisingits beta agonist effect.The current standard is to administer a continuousphenylephrine infusion to prevent hypotension. However Phenylephrine whichacts by alpha-2 agonist action can cause a reflex fall in heart rate anddecreased cardiac output. The use of norepinephrine has been recentlythought of as a possible drug to maintain blood pressure following subarachnoidblock. And as it has a dual alpha and beta action, it has a lower tendency tocause cardiac depressant effects.

Studies havebeen done to compare Phenylephrine and Norepinephrine for management of postspinal hypotension with respect to their safety, efficacy and effect onneonatal outcome*.* But studies comparing manually titrated infusions arevery less.  The primary aim of this study is tocompare manual variable titrated infusion of phenylephrine and norepinephrinein preventing post subarachnoid block hypotension.  The secondary aim of this study will be tocompare incidences of maternal bradycardia, fetal acid-base balance, Apgarscore and the requirements of vasopressor doses.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-03
• Study Completion: 2021-06-20
• Last Update Posted: 2021-06-25

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 102

Inclusion Criteria

Grade 3 and 4 as per Lucas classification of urgency of caesarean section Pregnant females undergoing Caesarean section under spinal anaesthesia Age 18-35 years ASA grade 2 Gestational age more than 37 weeks with singleton pregnancy.

Exclusion Criteria

• Not consenting for the study ASA grades 3,4 Body weight <50kgs,>100kgs Height<140cm,>170cm Any pregnancy complications like pregnancy-induced hypertension, gestational diabetes,abruptio placenta, placenta previa Any medical diseases like Diabetes mellitus, Hypertension, Cardiac diseases, Severe anemia, Peripheral vascular diseases.
• Failed subarachnoid block Contraindication to Spinal Anaesthesia Patients on monoamine oxidase inhibitors and anti-depressants Spinal Deformities Diagnosed preoperative fetal compromise.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the incidence of post-spinal hypotension in women receiving phenylephrine versus norepinephrine infusion.	Every minute after spinal anaesthesia upto delivery of newborn.

Secondary Outcome Measures

Name	Time	Method
To compare incidences of maternal bradycardia, fetal acid-base balance, Apgar score and the requirements of vasopressor doses	Every minute after spinal anaesthesia upto delivery of newborn.

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 Raipur, CHHATTISGARH, India

All India Institute of Medical Sciences

🇮🇳Raipur, CHHATTISGARH, India

Dr Omer Mohammed Mujahid

Principal investigator

9632672742

omermohd1992@gmail.com