Spinal Anesthesia Induced Hypotension During Cesarean Section

NCT ID: NCT00846651

Last Updated: 2017-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-02-28

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.

Conditions

Hypotension

Keywords

spinal anesthesia; cesarean section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Colloid administration

Intervention Type: OTHER

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

phenylephrine infusion

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Crystalloid administration

Intervention Type: OTHER

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

phenylephrine infusion

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: OTHER

Crystalloid administration

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

Intervention Type: OTHER

phenylephrine infusion

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sonia Vaida

M.D, Vice chair for research, Anesthesia Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

PennState Hershey Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

IRB #29595

Identifier Type: -

Identifier Source: org_study_id