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Clinical Trials/NCT04789005
NCT04789005
Completed
Phase 3

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

Tribhuvan University Teaching Hospital, Institute Of Medicine.1 site in 1 country80 target enrollmentNovember 10, 2019

Overview

Phase
Phase 3
Intervention
Phenylephrine
Conditions
Spinal Induced-hypotension
Sponsor
Tribhuvan University Teaching Hospital, Institute Of Medicine.
Enrollment
80
Locations
1
Primary Endpoint
compare percentage of incidence of bradycardia between the two groups
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 10, 2019
End Date
May 5, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Tribhuvan University Teaching Hospital, Institute Of Medicine.
Responsible Party
Principal Investigator
Principal Investigator

ALLEN SUWAL

Resident Anaesthesiology

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Eligibility Criteria

Inclusion Criteria

  • Elective cesarean delivery under spinal anaesthesia ASA PS II Age ≥18 years Singleton pregnancy beyond 37 weeks' gestation Weight between 50 and 100 kg Height between 150 and 180 cm

Exclusion Criteria

  • Patient refusal to participate Allergy or hypersensitivity to Norepinephrine or Phenylephrine Preexisting or pregnancy-induced hypertension Cardiovascular or cerebrovascular disease Fetal abnormalities Use of monoamine oxidase inhibitors or tricyclic antidepressants

Arms & Interventions

Phenylephrine group

Phenylephrine 100mcg was administered manually by the anaesthesiologist every time the SBP was 20% lower than baseline and the HR ≥60 bpm.

Intervention: Phenylephrine

Norepinephrine group

Norepinephrine 8mcg was administered manually by the anaesthesiologist every time the SBP was 20% lower than baseline and the HR ≥60 bpm.

Intervention: Norepinephrine

Outcomes

Primary Outcomes

compare percentage of incidence of bradycardia between the two groups

Time Frame: 6 months

To compare percentage of incidence of hypotension between two groups.

Time Frame: 6 months

To compare blood pressure between two groups.

Time Frame: 6 months

Study Sites (1)

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