The Effect of Two Different Doses of Noradrenaline on Hypotension Caused by Spinal Anesthesia for Cesarean Section
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19-40
SponsorAssiut University
About this trial
To compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women scheduled for cesarean section under spinal anesthesia
Gestational age of at least 37 weeks
Disqualifiers
Patient refusal
Contraindications of spinal anesthesia
Allergy to the study drug
Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
Trial design
Design model
Parallel
Treatments tested in this trial
Norepinephrine (0.1)
DrugAn 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)
DrugAn intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.075 µg/kg/min till 5 minutes after delivery of the fetus.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Norepinephrine (0.1)Experimental treatment 1 intervention
Group B: Norepinephrine (0.075)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
The frequency of post-spinal hypotension
Time frame
During the first hour after the subarachnoid blockSecondary outcomes
1
Arterial blood pressure (Systolic, diastolic, and mean)
Time frame
During the first hour after the subarachnoid block2
Heart rate
Time frame
During the first hour after the subarachnoid block3
Doses of atropine and ephedrine
Time frame
Intraoperative4
Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score
Ranges from 0 (the worst score) to 10 (the best score)
Time frame
1, 5, and 10 minutes after deliverySponsors and contacts
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Source ClinicalTrials.gov