Spinal Anesthesia Induced Hypotension During Cesarean Section

Penn State Health

Status and phase: Completed; Phase 4

Conditions: Hypotension

Treatments: Other: Crystalloid administration; Other: Colloid administration; Drug: phenylephrine infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00846651

IRB #29595

Details and patient eligibility

About

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

Full 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.

Enrollment: 82 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

colloid, then phenylephrine infusion

Experimental group

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.

Treatment:

Drug: phenylephrine infusion

Other: Colloid administration

crystalloid, then phenylephrine infusion

Active Comparator group

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.

Treatment:

Drug: phenylephrine infusion

Other: Crystalloid administration