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Completed

NCT Number: NCT00846651

Spinal Anesthesia Induced Hypotension During Cesarean Section

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

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

PennState Hershey Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colloid administration

Other

The patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.

Crystalloid administration

Other

The patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.

Phenylephrine infusion

Drug

A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

Comparison of Phenylephrine Infusion With Colloids vs. Crystalloids for Reduction of Spinal-induced Hypotension During Cesarean Section

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Feb 19, 2009
Registry last updated
Oct 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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