Norepinephrine Versus Phenylephrine Continuous Variable Infusion in Cesarean Delivery

Cesarean Section Complications Clinical Trial

Official title:

Norepinephrine Versus Phenylephrine Continuous Variable Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Double-blinded Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03328533
• Other study ID #: N-82-2017
• Status: Completed
• Phase: Phase 4
• Start date: November 10, 2017
• Est. completion date: May 5, 2018

Study information

• Verified date: July 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: May 5, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Full term

• Pregnant women

• Scheduled for cesarean section

Exclusion Criteria:

• Pre-eclampsia

• Eclampsia

• Bleeding

• Cardiac dysfunction

Related Conditions & MeSH terms

• Cesarean Section Complications
• Spinal Anesthesia

Intervention

Drug:
• Phenylephrine
Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.
• Norepinephrine
Norepinephrine bitartrate variable infusion with a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min).
• Bupivacaine
Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post-spinal anesthesia hypotension.	Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading	30 minutes after spinal anesthesia
Secondary	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	30 minutes after spinal anesthesia
Secondary	Incidence of severe delivery hypotension	Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading	10 minutes after delivery
Secondary	Systolic blood pressure	Systolic blood pressure measured in mmHg	2 hours after subarachnoid block
Secondary	Heart rate	number of heart beats per minute	2 hours after subarachnoid block
Secondary	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	10 minutes after delivery
Secondary	Incidence of reactive hypertension	Defined as the percentage of patients with increased systolic blood pressure more than 80% of the baseline reading	2 hours after spinal anesthesia
Secondary	Umbilical arterial potential hydrogen (PH)	PH in the blood sample obtained from umbilical artery scaled from 1 to 14	10 minutes after delivery
Secondary	Umbilical arterial Partial pressure of Carbon dioxide	in the blood sample obtained from umbilical artery measured in mmHg	10 minutes after delivery
Secondary	incidence of nausea	The percentage of patients with nausea	2 hours
Secondary	Incidence of vomiting	The percentage of patients with nausea	2 hours
Secondary	Total phenylephrine consumption	the total dose of phenylephrine consumed during the operation	2 hours
Secondary	Total norepinephrine consumption	the total dose of norepinephrine consumed during the operation	2 hours
Secondary	Total ephedrine consumption	the total dose of ephedrine consumed during the operation	2 hours