Variable Rate Phenylephrine Infusion for Prevention of Spinal-induced Hypotension for Cesarean Delivery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sahar Sayyid, American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT01378325
First received: June 10, 2011
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Anesthetic Complication Spinal
Drug: Phenylephrine
Drug: saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by American University of Beirut Medical Center:

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. [ Time Frame: Patients will be followed up throughout the Cesarean delivery (average of 1.5 hours). ] [ Designated as safety issue: No ]

    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


Enrollment: 80
Study Start Date: July 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phenylephrine
PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery
Drug: Phenylephrine
Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline
Other Name: Neosynephrine
Placebo Comparator: Saline
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
Drug: saline
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Sahar Sayyid, anesthesia, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT01378325     History of Changes
Other Study ID Numbers: ANES.SS.10
Study First Received: June 10, 2011
Results First Received: July 2, 2014
Last Updated: August 11, 2014
Health Authority: Lebanon: Institutional Review Board

Keywords provided by American University of Beirut Medical Center:
spinal
cesarean delivery
phenylephrine
hypotension

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Phenylephrine
Oxymetazoline
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014