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Vasopressor Infusion in Cesarean Delivery

NCT03248791 — Phase 4, Unknown, 120 participants, Cairo University

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Comparison of Two Vasopressor Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Trial

RegistryNCT03248791
StatusUnknown
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: triple, prevention
Enrollment120 (Estimated)
SponsorCairo University (Other)
ConditionsCesarean Section Complications, Spinal Anesthesia
InterventionsPhenylephrine, Norepinephrine, Bupivacaine (Drug)
Datesstart 2017-08-20, primary completion 2022-03-01 (estimated), completion 2022-03-10 (estimated), first posted 2017-08-14, last updated 2021-09-27
Locations1 site in Egypt

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-Summary

Comparison will be conducted between continuous variable infusions of both drugs (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against Post-spinal hypotension during cesarean delivery.

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+Detailed description

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to PE. In this study, we will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against PSH during CD.

+Arms and interventions

ArmTypeInterventionsDescription
PhenylephrineActive comparatorDrug: Phenylephrine; Drug: BupivacaineWill receive spinal anesthesia using Bupivacaine. Then, phenylephrine infusion by a starting rate of 0.75 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure
NorepinephrineExperimentalDrug: Norepinephrine; Drug: BupivacaineWill receive spinal anesthesia using Bupivacaine. Then, norepinephrine infusion by a starting rate of 0.1 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure
  • Phenylephrine (Drug): Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.
  • Norepinephrine (Drug), also known as noradrenaline: Norepinephrine variable infusion with a starting rate of 0.1 mcg/Kg/min.
  • Bupivacaine (Drug), also known as Marcaine: Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg

+Outcome measures

Primary outcomes

  • incidence of post-spinal anesthesia hypotension [30 minutes after spinal anesthesia]: Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading

Secondary outcomes

  • incidence of severe post-spinal anesthesia hypotension [30 minutes after spinal anesthesia]: Defined as the percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading
  • incidence of severe delivery hypotension [10 minutes after delivery]: Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading
  • systolic blood pressure [2 hours after subarachnoid block]: systolic blood pressure measured in mmHg
  • diastolic blood pressure [2 hours after subarachnoid block]: diastolic blood pressure measured in mmHg
  • heart rate [2 hours after subarachnoid block]: number of heart beats per minute
  • APGAR score [10 minutes after delivery]: APGAR score of the fetus
  • incidence of reactive hypertension [2 hours after spinal anesthesia]: Defined as the percentage of patients with increased systolic blood pressure more than 80% of the baseline reading

+Eligibility

Sex: Female, ages: 18 Years to 40 Years

Inclusion Criteria:

* full term
* pregnant women
* scheduled for cesarean section

Exclusion Criteria:

* pre-ecpamsia
* eclampsia
* bleeding
* cardiac dysfuction

+Locations (1)

FacilityCityCountryStatus
Cairo UniversityCairoEgyptRecruiting

+Investigators

My Notes