Phase 4
N=82
Spinal Anesthesia Induced Hypotension During Cesarean Section
Hypotension
Bottom Line
View on ClinicalTrials.gov: NCT00846651 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Incidence of Maternal Hypotension — 10.8; 27 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Colloid administration (Other); Crystalloid administration (Other); phenylephrine infusion (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Maternal Hypotension |
10.8; 27 | — |
| SECONDARY Dosage of Phenylephrine Used |
1077; 1477 | — |
| SECONDARY Incidence of Maternal Bradycardia |
35.1; 45.8 | — |
| SECONDARY Fetal Cord Blood pH |
— | — |
| SECONDARY APGAR Scores |
9; 9 | — |
| SECONDARY Incidence of Maternal Nausea and Vomiting |
16.2; 18.9 | — |
Summary
The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections.
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
Data sourced from ClinicalTrials.gov (NCT00846651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.