Spinal Anesthesia Induced Hypotension During Cesarean Section

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00846651
• Other study ID #: IRB #29595
• Status: Completed
• Phase: Phase 4
• First received: February 18, 2009
• Last updated: September 14, 2017
• Start date: February 2009
• Est. completion date: February 2010

Study information

• Verified date: September 2017
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension

Intervention

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.
• Crystalloid administration
The patients received 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.

Locations

Country	Name	City	State
United States	PennState Hershey Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dosage of Phenylephrine Used		participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
Secondary	Incidence of Maternal Bradycardia		participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
Secondary	Fetal Cord Blood pH		delivery of the baby
Secondary	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
Secondary	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