Spinal Anesthesia Induced Hypotension During Cesarean Section - Full Text View

Sponsored by:	Penn State University
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00846651

Purpose

The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections.

Condition	Intervention	Phase
Hypotension	Drug: Comparison of phenylephrine infusion with colloids vs. crystalloids	Phase IV

MedlinePlus related topics: Anesthesia Cesarean Section Low Blood Pressure Nausea and Vomiting

Drug Information available for: Phenylephrine Phenylephrine hydrochloride Oxymetazoline Oxymetazoline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Phenylephrine Infusion With Colloids vs. Crystalloids for Reduction of Spinal-Induced Hypotension During Cesarean Section

Further study details as provided by Penn State University:

Primary Outcome Measures:

Incidence of hypotension [ Time Frame: delivery of the baby ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

dosage of phenylephrine used [ Time Frame: delivery of the baby ] [ Designated as safety issue: Yes ]
incidence of maternal bradycardia [ Time Frame: delivery of the baby ] [ Designated as safety issue: Yes ]
Fetal cord blood pH [ Time Frame: delivery of the baby ] [ Designated as safety issue: Yes ]
APGAR scores [ Time Frame: delivery of the baby ] [ Designated as safety issue: Yes ]
incidence of maternal nausea and vomiting [ Time Frame: delivery of the baby ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	February 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental colloids	Drug: Comparison of phenylephrine infusion with colloids vs. crystalloids The patient will receive 0.5 L colloid solution (hydroxyethylstarch 6%) prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and will be continued until time of uterine incision.
2: Active Comparator crystalloids	Drug: Comparison of phenylephrine infusion with colloids vs. crystalloids The patient will receive 1.5 L Ringer's Lactate solution prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and will be continued until time of uterine incision.

Detailed Description:

Many women experience low blood pressure after spinal anesthesia for Cesarean section. This low blood pressure may result in nausea, vomiting dizziness and impairment of uterine blood flow.The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections. In both methods, we will attempt to prevent low blood pressure using phenylephrine infusion that has been shown to be effective in recent research. In addition to receiving phenylephrine one group of patients will receive standard salt solution (Ringer's lactate solution), while the other group will receive a different, intravenous fluid called hydroxyethylstarch.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status I and II
Elective cesarean section
Weight 50-120 kg, Height 150-180 cm
Normal singleton pregnancy
Beyond 36 weeks gestation
No known fetal abnormalities
Ages 18-35

Exclusion Criteria:

Contraindications to spinal anesthesia
Multiple gestation, placenta previa, accreta
Pregnancy induced hypertension or preeclampsia
Diabetes mellitus, cardiovascular diseases
Coagulopathy
Spinal cord abnormalities, spinal surgery, or preexisting neurological dysfunction
Baseline HR <65
Failed spinal anesthesia/inadequate sensory block for surgery
History of abnormal bleeding
History of adverse reactions to hydroxyethylstarch

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846651

Contacts

Contact: Sonia J Vaida, M.D.

717-531-0000 ext 8434

Locations

United States, Pennsylvania
PennState Hershey Milton S. Hershey Medical Center	Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Sonia J Vaida, M.D. 717-531-0000 ext 8434 svaida@hmc.psu.edu

Sponsors and Collaborators

Penn State University

More Information

No publications provided

Responsible Party:	PennState Hershey Milton S. Hershey Medical Center ( Sonia J Vaida )
Study ID Numbers:	IRB #29595
Study First Received:	February 18, 2009
Last Updated:	February 18, 2009
ClinicalTrials.gov Identifier:	NCT00846651 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Penn State University:

spinal anesthesia
cesarean section

Study placed in the following topic categories:

Pseudoephedrine
Hypotension
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Vascular Diseases
Anesthetics
Central Nervous System Depressants
Cardiovascular Agents

Adrenergic Agonists
Nasal Decongestants
Oxymetazoline
Mydriatics
Phenylephrine
Vasoconstrictor Agents
Ephedrine
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Hypotension
Respiratory System Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Physiological Effects of Drugs
Anesthetics
Adrenergic Agonists
Nasal Decongestants
Phenylephrine
Therapeutic Uses
Vasoconstrictor Agents

Cardiovascular Diseases
Adrenergic alpha-Agonists
Sympathomimetics
Vascular Diseases
Central Nervous System Depressants
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Oxymetazoline
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009