Norepinephrine Versus Phenylephrine Continuous Variable Infusion in Cesarean Delivery
- Conditions
- Cesarean Section ComplicationsSpinal Anesthesia
- Interventions
- Registration Number
- NCT03328533
- Lead Sponsor
- Cairo University
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 123
- Full term
- Pregnant women
- Scheduled for cesarean section
- Pre-eclampsia
- Eclampsia
- Bleeding
- Cardiac dysfunction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phenylephrine Phenylephrine 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. Phenylephrine Bupivacaine 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. Norepinephrine Norepinephrine 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. Norepinephrine 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.
- Primary Outcome Measures
Name Time Method Incidence of post-spinal anesthesia hypotension. 30 minutes after spinal anesthesia Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading
- Secondary Outcome Measures
Name Time Method Incidence of severe post-spinal anesthesia hypotension 30 minutes after spinal anesthesia Defined as the percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading
Incidence of severe delivery hypotension 10 minutes after delivery Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading
Systolic blood pressure 2 hours after subarachnoid block Systolic blood pressure measured in mmHg
Heart rate 2 hours after subarachnoid block number of heart beats per minute
APGAR score for assessment of the general state of the fetus 10 minutes after delivery APGAR score of the fetus ranging from 0 to 10. the higher the value, the better he score
Incidence of reactive hypertension 2 hours after spinal anesthesia Defined as the percentage of patients with increased systolic blood pressure more than 80% of the baseline reading
Umbilical arterial potential hydrogen (PH) 10 minutes after delivery PH in the blood sample obtained from umbilical artery scaled from 1 to 14
Umbilical arterial Partial pressure of Carbon dioxide 10 minutes after delivery in the blood sample obtained from umbilical artery measured in mmHg
incidence of nausea 2 hours The percentage of patients with nausea
Incidence of vomiting 2 hours The percentage of patients with nausea
Total phenylephrine consumption 2 hours the total dose of phenylephrine consumed during the operation
Total norepinephrine consumption 2 hours the total dose of norepinephrine consumed during the operation
Total ephedrine consumption 2 hours the total dose of ephedrine consumed during the operation
Trial Locations
- Locations (1)
Cairo University
🇪🇬Cairo, Egypt