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Clinical Trials/NCT03507387
NCT03507387
Completed
Not Applicable

Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Tiral

Xuzhou Medical University1 site in 1 country99 target enrollmentApril 1, 2018

Overview

Phase
Not Applicable
Intervention
Phenylephrine
Conditions
Elective Cesarean Section
Sponsor
Xuzhou Medical University
Enrollment
99
Locations
1
Primary Endpoint
Umbilical artery potential of hydrogen (pH)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Spinal anesthesia is the preferred anesthesia method in cesarean section to provide satisfactory analgesia and muscle relaxant with less impact on respiratory system. However, hypotension often occurred due to the block of sympathetic nerve, causing maternal decline of frontal lobe oxygenation, nausea vomit and the decrease of uteroplacental perfusion. Several measures are used to prevent or treat hypotension caused by spinal anesthesia: prehydration, limb compression, left lateral tilt of operation tables or usage of vasopressors. In the past decade, the most recommended vasopressor to prevent or treat hypotension in spinal anesthesia in cesarean section was phenylephrine, an α-adrenergic receptor, maintaining maternal blood pressure and fetal acid-base state. In clinical work, there are two ways to use phenylephrine : intravenous method with less onset time (several seconds and duration (several minutes) and intramuscular method with longer onset time (10-15 minutes) and duration (1 hour). Many trials demonstrated the protective effect of preventive intravenous phenylephrine on maternal hemodynamics and neonatal acid-base status. However, few trials reported the effect of preventive intramuscular phenylephrine on cesarean section under spinal anesthesia.

Detailed Description

Hypotension often occurred in parturients undergoing cesarean section in spinal anesthesia. This study aims to determine whether preventive intramuscular phenylephrine can better the fetal acid-base state and maternal hemodynamics.

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
August 31, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Xuzhou Medical University
Responsible Party
Principal Investigator
Principal Investigator

Chao Xu

Principal Investigator

Xuzhou Medical University

Eligibility Criteria

Inclusion Criteria

  • Age 18 years to 40 years.
  • Elective cesarean section
  • American Society of Anesthesiologists (ASA) grade from I to Ⅱ, height from 150 cm to 180 cm, BMI\<40kg/m2
  • Singleton pregnancy
  • Without pregnancy complications

Exclusion Criteria

  • Multiple pregnancy
  • Preoperative bradycardia
  • Coagulation dysfunction
  • Parturients with hypertension, diabetes, eclampsia and other pregnancy complications.

Arms & Interventions

Intramuscular phenylephrine group

Patients in intramuscular phenylephrine group will receive spinal anesthesia with bupivacaine. 5 mg (1ml) phenylephrine intramuscular injection will be given into the gluteus maximus muscle before anesthesia.1ml of 0.9% normal saline intravenous injection will be given after the subarachnoid injection is completed.

Intervention: Phenylephrine

Intramuscular phenylephrine group

Patients in intramuscular phenylephrine group will receive spinal anesthesia with bupivacaine. 5 mg (1ml) phenylephrine intramuscular injection will be given into the gluteus maximus muscle before anesthesia.1ml of 0.9% normal saline intravenous injection will be given after the subarachnoid injection is completed.

Intervention: Normal saline

Intramuscular phenylephrine group

Patients in intramuscular phenylephrine group will receive spinal anesthesia with bupivacaine. 5 mg (1ml) phenylephrine intramuscular injection will be given into the gluteus maximus muscle before anesthesia.1ml of 0.9% normal saline intravenous injection will be given after the subarachnoid injection is completed.

Intervention: Bupivacaine

Intravenous phenylephrine group

Patients in intravenous phenylephrine group will receive spinal anesthesia with bupivacaine. 1ml of 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia.100ug (1ml) phenylephrine intravenous injection will be given after the subarachnoid injection is completed.

Intervention: Phenylephrine

Intravenous phenylephrine group

Patients in intravenous phenylephrine group will receive spinal anesthesia with bupivacaine. 1ml of 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia.100ug (1ml) phenylephrine intravenous injection will be given after the subarachnoid injection is completed.

Intervention: Normal saline

Intravenous phenylephrine group

Patients in intravenous phenylephrine group will receive spinal anesthesia with bupivacaine. 1ml of 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia.100ug (1ml) phenylephrine intravenous injection will be given after the subarachnoid injection is completed.

Intervention: Bupivacaine

Placebo group

Patients in intravenous phenylephrine group will receive spinal anesthesia with bupivacaine. 1ml of 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia. 1ml of 0.9% normal saline intravenous injection will be given after the subarachnoid injection is completed.

Intervention: Phenylephrine

Placebo group

Patients in intravenous phenylephrine group will receive spinal anesthesia with bupivacaine. 1ml of 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia. 1ml of 0.9% normal saline intravenous injection will be given after the subarachnoid injection is completed.

Intervention: Normal saline

Placebo group

Patients in intravenous phenylephrine group will receive spinal anesthesia with bupivacaine. 1ml of 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia. 1ml of 0.9% normal saline intravenous injection will be given after the subarachnoid injection is completed.

Intervention: Bupivacaine

Outcomes

Primary Outcomes

Umbilical artery potential of hydrogen (pH)

Time Frame: after the baby is delivered

detected by a blood gase analyzer

Secondary Outcomes

  • Umbilical venous partial pressure of oxygen (PaO2)(after the baby is delivered)
  • Umbilical artery base excess(after the baby is delivered)
  • Umbilical venous potential of hydrogen (pH)(after the baby is delivered)
  • Umbilical venous base excess(after the baby is delivered)
  • Umbilical venous lactate(after the baby is delivered)
  • Umbilical venous glucose(after the baby is delivered)
  • Incidence of fetal acidosis(after the baby is delivered)
  • Umbilical artery partial pressure of carbon dioxide (PaCO2)(after the baby is delivered)
  • Umbilical venous partial pressure of carbon dioxide (PaCO2)(after the baby is delivered)
  • Umbilical artery lactate(after the baby is delivered)
  • Incidence of hypotension(intraoperative)
  • Umbilical artery partial pressure of oxygen (PaO2)(after the baby is delivered)
  • Incidence of hypertension(intraoperative)
  • Incidence of bradycardia(intraoperative)
  • Umbilical artery glucose(after the baby is delivered)
  • Incidence of nausea or vomit(intraoperative)

Study Sites (1)

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