Hypotension Clinical Trial
— annie-manosOfficial title:
Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion. Does Time and Type of Administered Fluids Matter?
Verified date | June 2021 |
Source | Aretaieion University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This will be a randomized study aiming at investigating the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section
Status | Completed |
Enrollment | 100 |
Est. completion date | April 30, 2021 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 48 Years |
Eligibility | Inclusion Criteria: - adult parturients, American Society of Anesthesiologists (ASA) I-II, - singleton gestation>37 weeks - elective cesarean section Exclusion Criteria: - Body Mass Index (BMI) >40 kg/m2 - Body weight <50 kg - Body weight>100 kg - height<150 cm - height>180 cm - multiple gestation - fetal abnormality - fetal distress - active labor - cardiac disease - pregnancy-induced hypertension - thrombocytopenia - coagulation abnormalities - use of antihypertensive medication during pregnancy - communication or language barriers - lack of informed consent - contraindication for regional anesthesia |
Country | Name | City | State |
---|---|---|---|
Greece | Alexandra General Hospital of Athens | Athens | |
Greece | Aretaieion University Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
Aretaieion University Hospital | Alexandra Hospital, Athens, Greece |
Greece,
Afolabi BB, Lesi FE. Regional versus general anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Oct 17;10:CD004350. doi: 10.1002/14651858.CD004350.pub3. Review. — View Citation
Banerjee A, Stocche RM, Angle P, Halpern SH. Preload or coload for spinal anesthesia for elective Cesarean delivery: a meta-analysis. Can J Anaesth. 2010 Jan;57(1):24-31. doi: 10.1007/s12630-009-9206-7. Epub 2009 Oct 27. — View Citation
Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. — View Citation
Klöhr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23. Review. — View Citation
Li L, Zhang Y, Tan Y, Xu S. Colloid or crystalloid solution on maternal and neonatal hemodynamics for cesarean section: a meta-analysis of randomized controlled trials. J Obstet Gynaecol Res. 2013 May;39(5):932-41. doi: 10.1111/jog.12001. Epub 2013 Feb 4. — View Citation
Mercier FJ. Fluid loading for cesarean delivery under spinal anesthesia: have we studied all the options? Anesth Analg. 2011 Oct;113(4):677-80. doi: 10.1213/ANE.0b013e3182245af4. — View Citation
Ngan Kee WD. Prevention of maternal hypotension after regional anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2010 Jun;23(3):304-9. doi: 10.1097/ACO.0b013e328337ffc6. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of hypotension | any occurence of hypotension (systolic blood pressure<80% of baseline) throughout the operation will be recorded | intraoperative | |
Secondary | need for vasoconstrictor | any need for vasoconstrictor during the operation will be recorded | intraoperative | |
Secondary | type of vasoconstrictor administered | phenylephrine versus ephedrine | intraoperative | |
Secondary | total dose of vasoconstrictor administered | total dose in mg for ephedrine or µg for phenylephrine administered | intraoperative | |
Secondary | incidence of hypertension | any incidence of systolic blood pressure>120% of baseline will be recorded | intraoperative | |
Secondary | incidence of bradycardia | any incidence of maternal bradycardia (heart rate<60/min) will be recorded | intraoperative | |
Secondary | need for atropine | any need for atropine during the operation because of bradycardia will be recorded | intraoperative | |
Secondary | modification or cessation of the infusion | any requirement for modification or cessation of the infusion due to reactive hypertension or bradycardia will be recorded | intraoperative | |
Secondary | incidence of nausea/vomiting | any occurence of nausea and/or vomiting during the operation will be recorded | intraoperative | |
Secondary | Neonatal Apgar score at 1 min | Neonatal Apgar score will be recorded at 1 min after delivery. 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. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts. | 1 min post delivery | |
Secondary | Neonatal Apgar score at 5 min | Neonatal Apgar score will be recorded at 5 min after delivery. 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. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts. | 5 min post delivery | |
Secondary | neonatal blood gases | fetal cord blood analysis will be performed immediately post-delivery | 1 min post delivery | |
Secondary | glucose in neonatal blood | glucose will be measured in the cord blood gas sample taken immediately post-delivery | 1 min post delivery |
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