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NCT06102382 Clinical Trial

The Effect of Two Different Doses of Noradrenaline on Hypotension Caused by Spinal Anesthesia for Cesarean Section

Hypotension Clinical Trial

Official title:
The Effect of Two Different Doses of Noradrenaline on Hypotension Caused by Spinal Anesthesia for Cesarean Section

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06102382
Other study ID # Noradrenaline in CS under SA
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 10, 2023
Est. completion date December 10, 2024

Study information
Verified date October 2023
Source Assiut University
Contact Zakaria A. Zakaria
Phone +201150637566
Email za6841924@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.

Description:

Hypotension after spinal anesthesia for cesarean delivery is common and is caused mainly by peripheral vasodilatation. Although the intravenous administration of fluids helps, it does not always prevent maternal hypotension. Usually, this hypotension is treated with phenylephrine or ephedrine. Norepinephrine has been recently introduced for prophylaxis against post-spinal hypotension during cesarean delivery due to its α-adrenergic activity in addition to the weak β-adrenergic activity. Although the use of norepinephrine for this purpose has shown promising results. However, no sufficient data are available with regard to its optimum dose. The objective of this study is to compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date December 10, 2024
Est. primary completion date December 10, 2024
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 40 Years
Eligibility Inclusion Criteria: - Pregnant women scheduled for cesarean section under spinal anesthesia - Gestational age of at least 37 weeks Exclusion Criteria: - Patient refusal - Contraindications of spinal anesthesia - Allergy to the study drug - Height<150 cm, weight < 60 kg, body mass index (BMI) =40 kg/m2. - patients with cardiac morbidities - Hypertensive disorders of pregnancy. - Prepartum hemorrhage

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Norepinephrine (0.1)
An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.1 µg/kg/min till 5 minutes after delivery of the fetus.
• Norepinephrine (0.075)
An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.075 µg/kg/min till 5 minutes after delivery of the fetus.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Outcome
Type Measure Description Time frame Safety issue
Primary The frequency of post-spinal hypotension During the first hour after the subarachnoid block
Secondary Arterial blood pressure (Systolic, diastolic, and mean) During the first hour after the subarachnoid block
Secondary Heart rate During the first hour after the subarachnoid block
Secondary Doses of atropine and ephedrine Intraoperative
Secondary Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score Ranges from 0 (the worst score) to 10 (the best score) 1, 5, and 10 minutes after delivery
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