phenylephrine infusion
ProcedureIn parturients allocated to the phenylephrine group, a phenylephrine infusion will be initiated as soon as spinal anesthesia is established
NCT Number: NCT03842046
The aim of this double-blind randomized study will be to compare a fixed-rate prophylactic noradrenaline infusion to a fixed-rate prophylactic phenylephrine infusion during elective cesarean section under combined spinal-epidural anesthesia
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Notify Me18 year–48 year
Female
Interventional
Not applicable
Alexandra General Hospital of Athens, Athens, Greece
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In parturients allocated to the phenylephrine group, a phenylephrine infusion will be initiated as soon as spinal anesthesia is established
In parturients allocated to the norepinephrine group group, a phenylephrine infusion will be initiated as soon as spinal anesthesia is established
Time frame: intraoperative
any incidence of heart rate<60/min will be recorded
Time frame: intraoperative
parturient needed or not vasoconstrictor during the operation
Time frame: intraoperative
phenylephrine verus ephedrine
Time frame: intraoperative
number of provided interventions to maintain systolic blood pressure within the set limits will be recorded
Time frame: intraoperative
total dose in mg for ephedrine or μg for phenylephrine
Time frame: intraoperative
any occurrence of hypotension throughout the operation will be recorded (systolic arterial pressure<80% of baseline throughout the operation)
Time frame: intraoperative
any incidence of systolic blood pressure >120% of baseline will be recorded
Time frame: intraoperative
incidence of nausea and vomiting throughout the operation
Time frame: 1 min post delivery
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.
Time frame: 5 min post delivery
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.
Time frame: 1 min post delivery
fetal cord blood analysis will be performed immediately post-delivery
Time frame: 1 min post delivery
glucose will be measured in the cord blood gas sample taken immediately post-delivery
Aretaieion University Hospital
Other
Comparison of Continuous Infusion of Noradrenaline Versus Phenylephrine During Cesarean Section Under Spinal Anesthesia. A Randomized Controlled Trial
Acronym: NOR-PHEN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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