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Spinal Anesthesia Induced Hypotension During Cesarean Section

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ClinicalTrials.gov Identifier: NCT00846651
Recruitment Status : Completed
First Posted : February 19, 2009
Results First Posted : July 3, 2013
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
Sonia Vaida, Penn State University

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

Condition or disease Intervention/treatment Phase
Hypotension Other: Colloid administration Other: Crystalloid administration Drug: phenylephrine infusion Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Phenylephrine Infusion With Colloids vs. Crystalloids for Reduction of Spinal-induced Hypotension During Cesarean Section
Study Start Date : February 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : February 2010


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Fetal Cord Blood pH [ Time Frame: delivery of the baby ]
  4. APGAR Scores [ Time Frame: Apgar scores were assessed at 1 amd 5 min after delivery of the baby ]
    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).

  5. 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 ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00846651


Locations
United States, Pennsylvania
PennState Hershey Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center

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
First Posted: February 19, 2009    Key Record Dates
Results First Posted: July 3, 2013
Last Update Posted: October 16, 2017
Last Verified: September 2017

Keywords provided by Sonia Vaida, 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
Cardiotonic 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