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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intramuscular phenylephrine group | Experimental | 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 | Active Comparator | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine | Drug | 5 mg (1ml) phenylephrine 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| Umbilical artery potential of hydrogen (pH) | detected by a blood gase analyzer | after the baby is delivered |
| Measure | Description | Time Frame |
|---|---|---|
| Umbilical venous potential of hydrogen (pH) | detected by a blood gase analyzer | after the baby is delivered |
| Umbilical artery base excess | detected by a blood gase analyzer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chao Xu, M.D. | The Affiliated Hospital of Xuzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24624090 | Result | Foss VT, Christensen R, Rokamp KZ, Nissen P, Secher NH, Nielsen HB. Effect of phenylephrine vs. ephedrine on frontal lobe oxygenation during caesarean section with spinal anesthesia: an open label randomized controlled trial. Front Physiol. 2014 Mar 3;5:81. doi: 10.3389/fphys.2014.00081. eCollection 2014. | |
| 17215703 | Result |
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| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| D000077330 | Saline Solution |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Normal saline | Drug | 1ml 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia and after the subarachnoid injection is completed. |
|
|
| Bupivacaine | Drug | All patients will receive spinal anesthesia with bupivacaine. |
|
|
| after the baby is delivered |
| Umbilical venous base excess | detected by a blood gase analyzer | after the baby is delivered |
| Umbilical artery partial pressure of oxygen (PaO2) | detected by a blood gase analyzer | after the baby is delivered |
| Umbilical venous partial pressure of oxygen (PaO2) | detected by a blood gase analyzer | after the baby is delivered |
| Umbilical artery partial pressure of carbon dioxide (PaCO2) | detected by a blood gase analyzer | after the baby is delivered |
| Umbilical venous partial pressure of carbon dioxide (PaCO2) | detected by a blood gase analyzer | after the baby is delivered |
| Umbilical artery lactate | detected by a blood gase analyzer | after the baby is delivered |
| Umbilical venous lactate | detected by a blood gase analyzer | after the baby is delivered |
| Umbilical artery glucose | detected by a blood gase analyzer | after the baby is delivered |
| Umbilical venous glucose | detected by a blood gase analyzer | after the baby is delivered |
| Incidence of fetal acidosis | Umbilical artery pH value<7.20 | after the baby is delivered |
| Incidence of hypotension | decrease of systolic blood pressure>20% baseline values | intraoperative |
| Incidence of hypertension | increase of systolic blood pressure>20% baseline values | intraoperative |
| Incidence of bradycardia | heart rate <50 bpm | intraoperative |
| Incidence of nausea or vomit | observed by the anesthesiologist | intraoperative |
| Macarthur A, Riley ET. Obstetric anesthesia controversies: vasopressor choice for postspinal hypotension during cesarean delivery. Int Anesthesiol Clin. 2007 Winter;45(1):115-32. doi: 10.1097/AIA.0b013e31802b8d53. No abstract available. |
| 28235526 | Result | Mon W, Stewart A, Fernando R, Ashpole K, El-Wahab N, MacDonald S, Tamilselvan P, Columb M, Liu YM. Cardiac output changes with phenylephrine and ephedrine infusions during spinal anesthesia for cesarean section: A randomized, double-blind trial. J Clin Anesth. 2017 Feb;37:43-48. doi: 10.1016/j.jclinane.2016.11.001. Epub 2016 Dec 26. |
| 8672382 | Result | Thomas DG, Robson SC, Redfern N, Hughes D, Boys RJ. Randomized trial of bolus phenylephrine or ephedrine for maintenance of arterial pressure during spinal anaesthesia for Caesarean section. Br J Anaesth. 1996 Jan;76(1):61-5. doi: 10.1093/bja/76.1.61. |
| 22759268 | Result | Lin FQ, Qiu MT, Ding XX, Fu SK, Li Q. Ephedrine versus phenylephrine for the management of hypotension during spinal anesthesia for cesarean section: an updated meta-analysis. CNS Neurosci Ther. 2012 Jul;18(7):591-7. doi: 10.1111/j.1755-5949.2012.00345.x. |
| 27020488 | Result | Mohta M, Aggarwal M, Sethi AK, Harisinghani P, Guleria K. Randomized double-blind comparison of ephedrine and phenylephrine for management of post-spinal hypotension in potential fetal compromise. Int J Obstet Anesth. 2016 Aug;27:32-40. doi: 10.1016/j.ijoa.2016.02.004. Epub 2016 Feb 21. |
| 16311286 | Result | Saravanan S, Kocarev M, Wilson RC, Watkins E, Columb MO, Lyons G. Equivalent dose of ephedrine and phenylephrine in the prevention of post-spinal hypotension in Caesarean section. Br J Anaesth. 2006 Jan;96(1):95-9. doi: 10.1093/bja/aei265. Epub 2005 Nov 25. |
| 19374211 | Result | Magalhaes E, Goveia CS, de Araujo Ladeira LC, Nascimento BG, Kluthcouski SM. Ephedrine versus phenylephrine: prevention of hypotension during spinal block for cesarean section and effects on the fetus. Rev Bras Anestesiol. 2009 Jan-Feb;59(1):11-20. doi: 10.1590/s0034-70942009000100003. English, Portuguese. |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |