Vasopressor Prophylaxis After Spinal Anesthesia: A Dose Finding Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 270
- Locations
- 1
- Primary Endpoint
- incidence of postspinal hypotension
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
- 0.05 mcg /Kg/min group
will receive norepinephrine 0.05 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
Intervention: Bupivacaine (Drug)
- 0.05 mcg /Kg/min group
will receive norepinephrine 0.05 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
Intervention: Norepinephrine 0.05 mcg /Kg/min (Drug)
- 0.1 mcg /Kg/min group
will receive norepinephrine 0.1 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
Intervention: Norepinephrine 0.1 mcg /Kg/min (Drug)
- 0.1 mcg /Kg/min group
will receive norepinephrine 0.1 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
Intervention: Bupivacaine (Drug)
- 0.15 mcg /Kg/min group
will receive norepinephrine 0.15 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
Intervention: Norepinephrine 0.15 mcg /Kg/min (Drug)
- 0.15 mcg /Kg/min group
will receive norepinephrine 0.15 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
Intervention: Bupivacaine (Drug)
Outcomes
Primary Outcomes
incidence of postspinal hypotension
Time Frame: 30 minutes after spinal anesthesia
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
Secondary Outcomes
- heart rate(90 minutes after spinal anesthesia)
- vomiting(120 minutes after spinal anesthesia)
- nausea(120 minutes after spinal anesthesia)
- ephedrine consumption(60 minutes after spinal anesthesia)
- Atropine consumption(60 minutes after spinal anesthesia)
- APGAR score(10 minutes after delivery)
- incidence of severe postspinal hypotension(30 minutes after spinal anesthesia)
- arterial blood pressure(90 minutes after spinal anesthesia)
Investigators
Ahmed Hasanin
Principal investigator, Lecturer of anesthesia and critical care medicine
Cairo University