Comparison of Phenylephrine and Norepinephrine for Spinal-induced Hypotension

Phase 3

Completed

• Conditions: Spinal Induced-hypotension
• Interventions: Drug: Phenylephrine; Drug: Norepinephrine

• Registration Number: NCT04789005
• Lead Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-10
• Primary Completion: 2020-05-05
• Study Completion: 2020-05-05
• Study First Submitted: 2021-02-10
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-04
• Last Update Submitted: 2021-03-04
• Study First Posted: 2021-03-09
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
compare percentage of incidence of bradycardia between the two groups	6 months
To compare percentage of incidence of hypotension between two groups.	6 months
To compare blood pressure between two groups.	6 months

Trial Locations

Locations (1)

Tribhuvan university teaching hospital; 🇳🇵 Kathmandu, Bagmati, Nepal