A Phase 4 interventional study of Phenylephrine and Norepinephrine in Cesarean Section Complications and Spinal Anesthesia, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-07-17.
Sponsored by Cairo University · Phase 4, Interventional, and Prevention
Comparison will be conducted between continuous variable infusions of Phenylephrine with starting dose of 0.75 mcg/Kg/min and Norepinephrine Bitartrate with starting dose of 0.1 mcg/Kg/min (with norepinephrine base of 0.05 mcg/Kg/min) for prophylaxis against Post-spinal hypotension during cesarean delivery
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to PE. In this study, the investigators will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.05 mcg/Kg/min respectively for prophylaxis against PSH during CD. We used Norepinephrine Bitartrate 8 mg ampules which contains norepinephrine base of 4 mg.
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Will receive spinal anesthesia using Bupivacaine. Then, phenylephrine infusion by a starting rate of 0.75 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred.
Drug: Phenylephrine · Drug: Bupivacaine
Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine bitartrate infusion by a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min). The rate will be then adjusted according to the patient blood pressure. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred.
Drug: Norepinephrine · Drug: Bupivacaine
Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.
Norepinephrine bitartrate variable infusion with a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min).
Also known as: Levophed
Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg.
Also known as: Marcaine
Incidence of post-spinal anesthesia hypotension.
Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading
Time frame: 30 minutes after spinal anesthesia
Incidence of severe post-spinal anesthesia hypotension
Defined as the percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading
Time frame: 30 minutes after spinal anesthesia
Incidence of severe delivery hypotension
Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading
Time frame: 10 minutes after delivery
Systolic blood pressure
Systolic blood pressure measured in mmHg
Time frame: 2 hours after subarachnoid block
Heart rate
number of heart beats per minute
Time frame: 2 hours after subarachnoid block
APGAR score for assessment of the general state of the fetus
APGAR score of the fetus ranging from 0 to 10. the higher the value, the better he score
Time frame: 10 minutes after delivery
Incidence of reactive hypertension
Defined as the percentage of patients with increased systolic blood pressure more than 80% of the baseline reading
Time frame: 2 hours after spinal anesthesia
Umbilical arterial potential hydrogen (PH)
PH in the blood sample obtained from umbilical artery scaled from 1 to 14
Time frame: 10 minutes after delivery
Umbilical arterial Partial pressure of Carbon dioxide
in the blood sample obtained from umbilical artery measured in mmHg
Time frame: 10 minutes after delivery
incidence of nausea
The percentage of patients with nausea
Time frame: 2 hours
Incidence of vomiting
The percentage of patients with nausea
Time frame: 2 hours
Total phenylephrine consumption
the total dose of phenylephrine consumed during the operation
Time frame: 2 hours
Total norepinephrine consumption
the total dose of norepinephrine consumed during the operation
Time frame: 2 hours
Total ephedrine consumption
the total dose of ephedrine consumed during the operation
Time frame: 2 hours
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in May 2018, 5 months.
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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Norepinephrine