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