Clinical trial NCT00846651: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypotension
Keywords: spinal anesthesia
cesarean section
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Maternal Hypotension
timeFrame: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
Secondary outcomes:
measure: Dosage of Phenylephrine Used
timeFrame: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
measure: Incidence of Maternal Bradycardia
timeFrame: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
measure: Fetal Cord Blood pH
timeFrame: delivery of the baby
measure: APGAR Scores
timeFrame: Apgar scores were assessed at 1 amd 5 min after delivery of the baby
measure: Incidence of Maternal Nausea and Vomiting
timeFrame: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
Other outcomes:
Locations:
city: Hershey
country: United States
facility: PennState Hershey Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
References: