Comparison of Phenylephrine and Norepinephrine for Spinal-induced Hypotension

Spinal Induced-hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04789005
• Other study ID #: 439/(6-11)E²/076/077
• Status: Completed
• Phase: Phase 3
• Start date: November 10, 2019
• Est. completion date: May 5, 2020

Study information

• Verified date: March 2021
• Source: Tribhuvan University Teaching Hospital, Institute Of Medicine.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 5, 2020
• Est. primary completion date: May 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Spinal Induced-hypotension

Intervention

Drug:
• Norepinephrine
Norepinephrine 8mcg was administered manually by the anaesthesiologist every time the SBP was 20% lower than baseline and the HR =60 bpm.
• Phenylephrine
Phenylephrine 100mcg was administered manually by the anaesthesiologist every time the SBP was 20% lower than baseline and the HR =60 bpm.

Locations

Country	Name	City	State
Nepal	Tribhuvan university teaching hospital	Kathmandu	Bagmati

Sponsors (1)

Lead Sponsor	Collaborator
Tribhuvan University Teaching Hospital, Institute Of Medicine.

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare blood pressure between two groups.		6 months
Primary	To compare percentage of incidence of hypotension between two groups.		6 months
Primary	compare percentage of incidence of bradycardia between the two groups		6 months