Vasopressor Infusion in Cesarean Delivery

Phase 4

• Conditions: Spinal Anesthesia; Cesarean Section Complications
• Interventions: Drug: Phenylephrine; Drug: Norepinephrine; Drug: Bupivacaine

• Registration Number: NCT03248791
• Lead Sponsor: Cairo University

Brief Summary

Comparison will be conducted between continuous variable infusions of both drugs (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively 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, we will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against PSH during CD.

Study Timeline

• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-11
• Study First Posted: 2017-08-14
• Study Start: 2017-08-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-27
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• full term
• pregnant women
• scheduled for cesarean section

Exclusion Criteria

• pre-ecpamsia
• eclampsia
• bleeding
• cardiac dysfuction

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
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
Norepinephrine	Bupivacaine	Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine infusion by a starting rate of 0.1 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure
Norepinephrine	Norepinephrine	Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine infusion by a starting rate of 0.1 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure

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 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
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
heart rate	2 hours after subarachnoid block	number of heart beats per minute
APGAR score	10 minutes after delivery	APGAR score of the fetus
systolic blood pressure	2 hours after subarachnoid block	systolic blood pressure measured in mmHg
diastolic blood pressure	2 hours after subarachnoid block	diastolic blood pressure measured in mmHg

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt