Spinal Anesthesia Induced Hypotension During Cesarean Section

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sonia Vaida, Penn State University
ClinicalTrials.gov Identifier:
NCT00846651
First received: February 18, 2009
Last updated: July 3, 2013
Last verified: July 2013
  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
Other: Colloid administration
Other: Crystalloid administration
Drug: phenylephrine infusion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Phenylephrine Infusion With Colloids vs. Crystalloids for Reduction of Spinal-induced Hypotension During Cesarean Section

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Incidence of Maternal Hypotension [ Time Frame: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dosage of Phenylephrine Used [ Time Frame: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby ] [ Designated as safety issue: Yes ]
  • Incidence of Maternal Bradycardia [ Time Frame: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the 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: Apgar scores were assessed at 1 amd 5 min after delivery of the baby ] [ Designated as safety issue: Yes ]
    The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10 with higher scores being better than lower scores. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration).

  • Incidence of Maternal Nausea and Vomiting [ Time Frame: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby ] [ Designated as safety issue: Yes ]

Enrollment: 82
Study Start Date: February 2009
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: colloid, then phenylephrine infusion
colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
Other: Colloid administration
The patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.
Drug: phenylephrine infusion
A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
Active Comparator: crystalloid, then phenylephrine infusion
crystalloid administration; The patients received 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
Other: Crystalloid administration
The patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.
Drug: phenylephrine infusion
A phenylephrine infusion will be started immediately after performing the spinal anesthesia and 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
PennState Hershey Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
  More Information

No publications provided

Responsible Party: Sonia Vaida, M.D, Vice chair for research, Anesthesia Department, Penn State University
ClinicalTrials.gov Identifier: NCT00846651     History of Changes
Other Study ID Numbers: IRB #29595
Study First Received: February 18, 2009
Results First Received: February 4, 2013
Last Updated: July 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
spinal anesthesia
cesarean section

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Phenylephrine
Oxymetazoline
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Cardiotonic Agents
Cardiovascular Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
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 16, 2014