Spinal Anesthesia Induced Hypotension During Cesarean Section
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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 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 |
- Incidence of hypotension [ Time Frame: delivery of the baby ] [ Designated as safety issue: Yes ]
- 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 ]
Enrollment: | 90 |
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: 1
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.
|
Active Comparator: 2
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.
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
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 |
Last Updated: | May 9, 2012 |
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 Adrenergic alpha-1 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Cardiovascular Agents Mydriatics Autonomic Agents Peripheral Nervous System Agents Sympathomimetics Vasoconstrictor Agents Nasal Decongestants Respiratory System Agents Protective Agents |
ClinicalTrials.gov processed this record on September 26, 2012