Vasopressor Infusion in Cesarean Delivery

Cesarean Section Complications Clinical Trial

Official title:

Comparison of Two Vasopressor Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03248791
• Other study ID #: N-86-2017
• Status: Recruiting
• Phase: Phase 4
• Start date: August 20, 2017
• Est. completion date: March 10, 2022

Study information

• Verified date: September 2021
• Source: Cairo University
• Contact: Ahmed Hasanin, Professor
• Phone: +201095076954
• Email: ahmedmohamedhasanin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 10, 2022
• Est. primary completion date: March 1, 2022
• 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-ecpamsia
• eclampsia
• bleeding
• cardiac dysfuction

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 variable infusion with a starting rate of 0.1 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	diastolic blood pressure	diastolic 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	APGAR score of the fetus	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