Completed

NCT Number: NCT04789005

Comparison of Phenylephrine and Norepinephrine for Spinal-induced Hypotension

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.

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Key information

Conditions

Spinal Induced-hypotension

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Tribhuvan university teaching hospital

Kathmandu, Bagmati, 00977, Nepal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

norepinephrine

Drug

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

Other names: Norepinephrine group

Phenylephrine

Drug

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

Other names: Phenylepherine group

Primary outcomes

To compare blood pressure between two groups.

Time frame: 6 months
To compare percentage of incidence of hypotension between two groups.

Time frame: 6 months
compare percentage of incidence of bradycardia between the two groups

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Mar 9, 2021
Registry last updated: Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.