NCT04789005

Comparison of Phenylephrine and Norepinephrine for Spinal-induced Hypotension

Comparison of Intravenous Phenylephrine and Norepinephrine for Treatment of Spinal-induced Hypotension in Caesarian Deliveries

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Hypotension after spinal anaesthesia for cesarean deliveries is frequently encountered. Phenylephrine an α-agonist is commonly used for the prevention and treatment of spinal-induced hypotension. Phenylephrine causes baroreceptor-mediated bradycardia leading to subsequent reduction in cardiac output. Preservation of heart rate and cardiac output is important in high-risk conditions such as placental insufficiency, fetal distress and maternal cardiac disease. Recently, norepinephrine has been found as effective as phenylephrine in treatment of spinal induced hypotension. When norepinephrine is used as a bolus, it is effective at maintaining blood pressure while also conferring a greater heart rate and cardiac output compared to phenylephrine.

Conditions

• Spinal Induced-hypotension

Interventions

Type	Name	Description
DRUG	Norepinephrine	Norepinephrine 8mcg was administered manually by the anaesthesiologist every time the SBP was 20% lower than baseline and the HR ≥60 bpm.
DRUG	Phenylephrine	Phenylephrine 100mcg was administered manually by the anaesthesiologist every time the SBP was 20% lower than baseline and the HR ≥60 bpm.

Timeline

• Start date: 2019-11-10
• Primary completion: 2020-05-05
• Completion: 2020-05-05
• First posted: 2021-03-09
• Last updated: 2021-03-09

Locations

1 site across 1 country: Nepal