Variable Rate Phenylephrine Infusion for Prevention of Spinal-induced Hypotension for Cesarean Delivery
Primary Purpose
Anesthetic Complication Spinal
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Phenylephrine
saline
Sponsored by
About this trial
This is an interventional prevention trial for Anesthetic Complication Spinal focused on measuring spinal, cesarean delivery, phenylephrine, hypotension
Eligibility Criteria
Inclusion Criteria:
- Parturients beyond 37 weeks gestation
- ASA І or ІІ
Exclusion Criteria:
- pregnancy-induced hypertension
- chronic hypertension
- multiple pregnancy
- fetal compromise
- diabetes mellitus
- polyhydramnios
- body weight >100 kg
- major systemic disease
- anemia (hemoglobin concentration<10 g/dl)
- clotting diathesis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Phenylephrine
Saline
Arm Description
PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery
Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
Outcomes
Primary Outcome Measures
Number of Physician Interventions Needed to Maintain Maternal Blood Pressure After Spinal Anesthesia Within 20% of Baseline and to Treat Bradycardia During Cesarean Delivery.
Physician interventions are triggered by hemodynamic changes more than 20% of baseline. The intervention can be one or more of the following:
stopping the phenylephrine infusion
changing the rate of phenylephrine infusion
rescue intravenous bolus of phenylephrine (100 µg) for hypotension
rescue intravenous bolus of atropine (0.4 mg) for bradycardia
Secondary Outcome Measures
Full Information
NCT ID
NCT01378325
First Posted
June 10, 2011
Last Updated
August 11, 2014
Sponsor
American University of Beirut Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01378325
Brief Title
Variable Rate Phenylephrine Infusion for Prevention of Spinal-induced Hypotension for Cesarean Delivery
Official Title
Crystalloid Coload Combined With Variable Rate Phenylephrine Infusion for Prevention of Hypotension During Spinal Anesthesia for Elective Cesarean Delivery vs Crystalloid Coload Alone
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Rapid administration of crystalloid immediately after induction of spinal anesthesia (coload) to be more effective in terms of managing hypotension as compared to administering crystalloid before spinal anesthesia (preload).
Phenylehrine infusion is a safe and effective way to reduce incidence and frequency of hypotension during SA for cesarean delivery. Hypotension was virtually eliminated by use of high-dose prophylactic phenylephrine infusion at a rate of 100 µg/min and rapid crystalloid coload up to two liters (administration at the time of SA). However, incidence of reactive hypertension was frequent up to 47% with decrease in maternal heart rate (HR). This may raise concern in patients in whom increase of blood pressure may be detrimental, like chronic hypertension and in the presence of a compromised uteroplacental blood flow. A recent study found that infusing phenylephrine at a fixed rate of 75 and 100 ug/min is associated with more episodes of hypertension than placebo or the lower infusion rates of 25 and 50 ug/min respectively. However, there was no reduction in the number of physician interventions (phenylephrine boluses and stopping the infusion) needed to maintain maternal systolic blood pressure within 20% of baseline among all groups. Prophylactic fixed rate infusions may have limited application in clinical practice, and a variable rate (i.e. modifying the rate according to hemodynamics) has been advocated. The bolus administration of phenylephrine to treat hypotension is still commonly used, but requests multiple interventions from the anesthesiologists and is time consuming.
Eighty patients scheduled for cesarean delivery under spinal anesthesia will be assigned to one of two groups. Immediately after spinal injection, rapid crystalloid colaod of lactated Ringer of 15 mL/kg over a period of 10-15 min will be initiated. Patients in Group I will receive infusion of normal saline (placebo) and patients in group II variable infusion rate of phenylephrine started at 0.75 ug/kg (close to the dose of 50 ug/min recommended for fixed infusion rate). The number of interventions needed to maintain maternal systolic blood pressure within 20% of baseline, hemodynamic performance, intraoperative nausea and vomiting, and umbilical cord blood gases will be compared between the two groups.
We will define a reliable and safe method to ensure maternal hemodynamic stability during spinal anesthesia for cesarean delivery with the least physician interference.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthetic Complication Spinal
Keywords
spinal, cesarean delivery, phenylephrine, hypotension
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phenylephrine
Arm Type
Experimental
Arm Description
PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
Neosynephrine
Intervention Description
Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
Primary Outcome Measure Information:
Title
Number of Physician Interventions Needed to Maintain Maternal Blood Pressure After Spinal Anesthesia Within 20% of Baseline and to Treat Bradycardia During Cesarean Delivery.
Description
Physician interventions are triggered by hemodynamic changes more than 20% of baseline. The intervention can be one or more of the following:
stopping the phenylephrine infusion
changing the rate of phenylephrine infusion
rescue intravenous bolus of phenylephrine (100 µg) for hypotension
rescue intravenous bolus of atropine (0.4 mg) for bradycardia
Time Frame
Patients will be followed up throughout the Cesarean delivery (average of 1.5 hours).
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Parturients beyond 37 weeks gestation
ASA І or ІІ
Exclusion Criteria:
pregnancy-induced hypertension
chronic hypertension
multiple pregnancy
fetal compromise
diabetes mellitus
polyhydramnios
body weight >100 kg
major systemic disease
anemia (hemoglobin concentration<10 g/dl)
clotting diathesis
12. IPD Sharing Statement
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Variable Rate Phenylephrine Infusion for Prevention of Spinal-induced Hypotension for Cesarean Delivery
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