Ignite Creation Date:
2024-05-05 @ 11:36 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01378325
Status:
COMPLETED
Last Update Posted:
2014-08-26
First Post:
2011-06-10
Brief Title:
Variable Rate Phenylephrine Infusion for Prevention of Spinal-induced Hypotension for Cesarean Delivery
Sponsor:
American University of Beirut Medical Center
Organization:
American University of Beirut Medical Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 µgmin 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 ugmin is associated with more episodes of hypertension than placebo or the lower infusion rates of 25 and 50 ugmin 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 ie 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 mLkg 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 075 ugkg close to the dose of 50 ugmin 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
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 µgmin 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 ugmin is associated with more episodes of hypertension than placebo or the lower infusion rates of 25 and 50 ugmin 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 ie 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 mLkg 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 075 ugkg close to the dose of 50 ugmin 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None