Vasopressor Prophylaxis After Spinal Anesthesia

Cesarean Section Complications Clinical Trial

Official title:

Vasopressor Prophylaxis After Spinal Anesthesia: A Dose Finding Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03234816
• Other study ID #: N_66_2017
• Status: Completed
• Phase: Phase 4
• Start date: August 2, 2017
• Est. completion date: December 10, 2018

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Norepinephrine has been recently introduced as a prophylactic vasopressor during Cesarean delivery with promising results ; However, the optimum dose for efficient prophylaxis with the least side effects is not known. In this study, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for prophylaxis against Post-Spinal 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 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 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, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for prophylaxis against PSH during CD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: December 10, 2018
• Est. primary completion date: November 2, 2018
• 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

• Aged between 18 and 40 years

Exclusion Criteria:

• Cardiac morbidities

• Hypertensive disorders of pregnancy,

• Peripartum bleeding

• Baseline systolic blood pressure (SBP) < 100 mmHg

• Body mass index > 35

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Drug:
• Norepinephrine 0.05 mcg /Kg/min
Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
• Norepinephrine 0.1 mcg /Kg/min
Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
• Norepinephrine 0.15 mcg /Kg/min
Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
• Bupivacaine
10 mg Bupivacaine intra-thecal for spinal anesthesia

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 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	heart rate	heart rate after spinal anesthesia measured in beat per minute	90 minutes after spinal anesthesia
Secondary	vomiting	incidence of vomiting after spinal anesthesia	120 minutes after spinal anesthesia
Secondary	nausea	incidence of nausea after spinal anesthesia	120 minutes after spinal anesthesia
Secondary	ephedrine consumption	total amount of ephedrine consumed after spinal anesthesia	60 minutes after spinal anesthesia
Secondary	Atropine consumption	total amount of atropine consumed after spinal anesthesia	60 minutes after spinal anesthesia
Secondary	APGAR score	APGAR score of the delivered fetus	10 minutes after delivery
Secondary	incidence of 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	arterial blood pressure	arterial blood pressure after spinal anesthesia measured in mmHg	90 minutes after spinal anesthesia