Spinal Anesthesia Induced Hypotension During Cesarean Section

Comparison of Phenylephrine Infusion With Colloids vs. Crystalloids for Reduction of Spinal-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.

Study Overview

• Status: Completed
• Conditions: Hypotension
• Intervention / Treatment: Other: Colloid administration; Drug: phenylephrine infusion; Other: Crystalloid administration

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • PennState Hershey Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: colloid, then phenylephrine infusion; 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.	Other: Colloid administration; The patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.; Drug: phenylephrine infusion; A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
Active Comparator: crystalloid, then phenylephrine infusion; 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.	Drug: phenylephrine infusion; A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.; Other: Crystalloid administration; The patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Maternal Hypotension	participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosage of Phenylephrine Used		participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
Incidence of Maternal Bradycardia		participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
Fetal Cord Blood pH		delivery of the baby
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).	Apgar scores were assessed at 1 amd 5 min after delivery of the baby
Incidence of Maternal Nausea and Vomiting		participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: February 18, 2009
• First Submitted That Met QC Criteria: February 18, 2009
• First Posted (Estimate): February 19, 2009

Study Record Updates

• Last Update Posted (Actual): October 16, 2017
• Last Update Submitted That Met QC Criteria: September 14, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: cesarean section; spinal anesthesia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: IRB #29595