Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia
- Conditions
- Spinal AnesthesiaElective Cesarean Section
- Interventions
- Registration Number
- NCT03507387
- Lead Sponsor
- Xuzhou Medical University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 99
- 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
- Multiple pregnancy
- Preoperative bradycardia
- Coagulation dysfunction
- Parturients with hypertension, diabetes, eclampsia and other pregnancy complications.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intramuscular phenylephrine group Normal saline 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. Intravenous phenylephrine group Normal saline 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. Placebo group Normal saline 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. Intramuscular phenylephrine group Phenylephrine 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. Intravenous phenylephrine group Phenylephrine 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. Intramuscular phenylephrine group Bupivacaine 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. Placebo group Bupivacaine 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. Intravenous phenylephrine group Bupivacaine 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. Placebo group Phenylephrine 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.
- Primary Outcome Measures
Name Time Method Umbilical artery potential of hydrogen (pH) after the baby is delivered detected by a blood gase analyzer
- Secondary Outcome Measures
Name Time Method Umbilical venous partial pressure of oxygen (PaO2) after the baby is delivered detected by a blood gase analyzer
Umbilical artery base excess after the baby is delivered detected by a blood gase analyzer
Umbilical venous potential of hydrogen (pH) after the baby is delivered detected by a blood gase analyzer
Umbilical venous base excess after the baby is delivered detected by a blood gase analyzer
Umbilical venous lactate after the baby is delivered detected by a blood gase analyzer
Umbilical venous glucose after the baby is delivered detected by a blood gase analyzer
Incidence of fetal acidosis after the baby is delivered Umbilical artery pH value\<7.20
Umbilical artery partial pressure of carbon dioxide (PaCO2) after the baby is delivered detected by a blood gase analyzer
Umbilical venous partial pressure of carbon dioxide (PaCO2) after the baby is delivered detected by a blood gase analyzer
Umbilical artery lactate after the baby is delivered detected by a blood gase analyzer
Incidence of hypotension intraoperative decrease of systolic blood pressure\>20% baseline values
Umbilical artery partial pressure of oxygen (PaO2) after the baby is delivered detected by a blood gase analyzer
Incidence of hypertension intraoperative increase of systolic blood pressure\>20% baseline values
Incidence of bradycardia intraoperative heart rate \<50 bpm
Umbilical artery glucose after the baby is delivered detected by a blood gase analyzer
Incidence of nausea or vomit intraoperative observed by the anesthesiologist
Trial Locations
- Locations (1)
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China