Back to resultsComparison of Phenylephrine and Norepinephrine for Spinal-induced Hypotension
Primary Purpose
Spinal Induced-hypotension
Status
Completed
Phase
Phase 3
Locations
Nepal
Study Type
Interventional
Intervention
Norepinephrine
Phenylephrine
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Induced-hypotension
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
Sites / Locations
- Tribhuvan university teaching hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Phenylephrine group
Norepinephrine group
Arm Description
Phenylephrine 100mcg was administered manually by the anaesthesiologist every time the SBP was 20% lower than baseline and the HR ≥60 bpm.
Norepinephrine 8mcg was administered manually by the anaesthesiologist every time the SBP was 20% lower than baseline and the HR ≥60 bpm.
Outcomes
Primary Outcome Measures
To compare blood pressure between two groups.
To compare percentage of incidence of hypotension between two groups.
compare percentage of incidence of bradycardia between the two groups
Secondary Outcome Measures
Full Information
NCT ID
NCT04789005
First Posted
February 10, 2021
Last Updated
March 4, 2021
Sponsor
Tribhuvan University Teaching Hospital, Institute Of Medicine.
1. Study Identification
Unique Protocol Identification Number
NCT04789005
Brief Title
Comparison of Phenylephrine and Norepinephrine for Spinal-induced Hypotension
Official Title
Comparison of Intravenous Phenylephrine and Norepinephrine for Treatment of Spinal-induced Hypotension in Caesarian Deliveries
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 10, 2019 (Actual)
Primary Completion Date
May 5, 2020 (Actual)
Study Completion Date
May 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tribhuvan University Teaching Hospital, Institute Of Medicine.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Induced-hypotension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phenylephrine group
Arm Type
Active Comparator
Arm Description
Phenylephrine 100mcg was administered manually by the anaesthesiologist every time the SBP was 20% lower than baseline and the HR ≥60 bpm.
Arm Title
Norepinephrine group
Arm Type
Experimental
Arm Description
Norepinephrine 8mcg was administered manually by the anaesthesiologist every time the SBP was 20% lower than baseline and the HR ≥60 bpm.
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
Norepinephrine group
Intervention Description
Norepinephrine 8mcg was administered manually by the anaesthesiologist every time the SBP was 20% lower than baseline and the HR ≥60 bpm.
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
Phenylepherine group
Intervention Description
Phenylephrine 100mcg was administered manually by the anaesthesiologist every time the SBP was 20% lower than baseline and the HR ≥60 bpm.
Primary Outcome Measure Information:
Title
To compare blood pressure between two groups.
Time Frame
6 months
Title
To compare percentage of incidence of hypotension between two groups.
Time Frame
6 months
Title
compare percentage of incidence of bradycardia between the two groups
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Tribhuvan university teaching hospital
City
Kathmandu
State/Province
Bagmati
ZIP/Postal Code
00977
Country
Nepal
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Phenylephrine and Norepinephrine for Spinal-induced Hypotension
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