Clinical trial NCT03234816: Vasopressor Prophylaxis After Spinal Anesthesia
Official title: Vasopressor Prophylaxis After Spinal Anesthesia: A Dose Finding Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section Complications
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 270
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence of postspinal hypotension
timeFrame: 30 minutes after spinal anesthesia
Secondary outcomes:
measure: heart rate
timeFrame: 90 minutes after spinal anesthesia
measure: vomiting
timeFrame: 120 minutes after spinal anesthesia
measure: nausea
timeFrame: 120 minutes after spinal anesthesia
measure: ephedrine consumption
timeFrame: 60 minutes after spinal anesthesia
measure: Atropine consumption
timeFrame: 60 minutes after spinal anesthesia
measure: APGAR score
timeFrame: 10 minutes after delivery
measure: incidence of severe postspinal hypotension
timeFrame: 30 minutes after spinal anesthesia
measure: arterial blood pressure
timeFrame: 90 minutes after spinal anesthesia
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Head of research committee section in anesthesia department
name: Ahmed Mukhtar, Professor
role: STUDY_DIRECTOR
References: