Back to resultsSpinal Anesthesia Induced Hypotension During Cesarean Section
Primary Purpose
Hypotension
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Colloid administration
Crystalloid administration
phenylephrine infusion
Sponsored by
About this trial
This is an interventional treatment trial for Hypotension focused on measuring spinal anesthesia, cesarean section
Eligibility 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
Sites / Locations
- PennState Hershey Milton S. Hershey Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
colloid, then phenylephrine infusion
crystalloid, then phenylephrine infusion
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Incidence of Maternal Hypotension
Secondary Outcome Measures
Dosage of Phenylephrine Used
Incidence of Maternal Bradycardia
Fetal Cord Blood pH
APGAR Scores
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
Full Information
NCT ID
NCT00846651
First Posted
February 18, 2009
Last Updated
September 14, 2017
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00846651
Brief Title
Spinal Anesthesia Induced Hypotension During Cesarean Section
Official Title
Comparison of Phenylephrine Infusion With Colloids vs. Crystalloids for Reduction of Spinal-induced Hypotension During Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
spinal anesthesia, cesarean section
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
colloid, then phenylephrine infusion
Arm Type
Experimental
Arm Description
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.
Arm Title
crystalloid, then phenylephrine infusion
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Colloid administration
Intervention Description
The patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.
Intervention Type
Other
Intervention Name(s)
Crystalloid administration
Intervention Description
The patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.
Intervention Type
Drug
Intervention Name(s)
phenylephrine infusion
Intervention Description
A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
Fetal Cord Blood pH
Time Frame
delivery of the baby
Title
APGAR Scores
Description
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).
Time Frame
Apgar scores were assessed at 1 amd 5 min after delivery of the baby
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
PennState Hershey Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
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