Norepinephrine Infusion Different Doses in Cesarean Delivery

Cesarean Section Complications Clinical Trial

Official title:

Norepinephrine Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Dose Finding Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182088
• Other study ID #: N-49-2017
• Status: Completed
• Phase: Phase 4
• Start date: June 15, 2017
• Est. completion date: December 30, 2017

Study information

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

Clinical Trial Summary

three doses (0.025 mcg/Kg/min, 0.050 mcg/Kg/min, and 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against Post-spinal anesthesia hypotension during Cesarean delivery.

Description:

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal hypotension (PSH) during CD.

Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonist activity in addition to a weak β adrenergic agonist activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used vasopressors in obstetric anesthesia).

Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with promising results; However, the optimum dose for efficient prophylaxis with the least side effects is not known.

In this study, three doses (0.025, 0.050, 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against PSH during CD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: December 30, 2017
• Est. primary completion date: December 25, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• full term

• singleton

• pregnant women

• scheduled for elective cesarean delivery

Exclusion Criteria:

• cardiac morbidities

• hypertensive disorders of pregnancy

• peripartum bleeding

• baseline systolic blood pressure (SBP) < 100 mmHg

• body mass index > 35 will be excluded from the study.

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Drug:
• norepinephrine infusion (0.025 mcg/Kg/min)
The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine bitartrate infusion of (0.05 mcg/Kg/min) equivalent to norepinephrine base of (0.025 mcg/Kg/min)
• norepinephrine infusion (0.050 mcg/Kg/min)
The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.1 mcg/Kg/min) equivalent to norepinephrine base of (0.050 mcg/Kg/min)
• norepinephrine infusion (0.075 mcg/Kg/min)
The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.15 mcg/Kg/min) equivalent to norepinephrine base of (0.075 mcg/Kg/min).
• Bupivacaine
The patient will receive spinal anesthesia using Bupivacaine (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	postspinal hypotension	The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group	30 minutes after spinal anesthesia
Secondary	severe postspinal hypotension	The number of patients who develop hypotension (defined as decreased SBP less than 60% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group	30 minutes after spinal anesthesia
Secondary	Post-delivery hypotension	number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading after delivery of the fetus and starting oxytocin infusion)	10 minutes after delivery
Secondary	systolic blood pressure	systolic blood pressure measured in mmHg	60 minutes after spinal block
Secondary	diastolic blood pressure	diastolic blood pressure measured in mmHg	60 minutes after spinal block
Secondary	heart rate	heart rate measured in beats per minute	60 minutes after spinal block
Secondary	intraoperative hypertension	number of patients who develop intraoperive hypertension (defined as increased systolic blood pressure by more than 20% of the baseline reading) divided by the total number of patients in the group	60 minutes after spinal block
Secondary	incidence of nausea and vomiting	number of patients who develop nausea and vomiting divided by the total number of patients in the group	60 minutes after spinal block
Secondary	ephedrine consumption	total amount of ephedrine consumed during the operation (measured in milligrams)	60 minutes after spinal block
Secondary	Atropine consumption	total amount of atropine consumed during the operation (measured in milligrams)	60 minutes after spinal block
Secondary	APGAR score	APGAR score for detection of the well being of the fetus	1 minute after delivery
Secondary	APGAR score	APGAR score for detection of the well being of the fetus	10 minutes after delivery