Comparison of Two Different Doses of Phenylephrine on Oxytocin Hemodynamic Effect

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorRawalpindi Medical College

About this trial

Cesarean section is one of the commonly performed surgical procedures in the world. Once baby is delivered during the surgical procedure anesthesiologist administer Oxytocin drug through IV cannula which helps the Uterus to contract so that excessive blood loss doesnt occur. But this is associated with fall in blood pressure frequently requiring administration of medications to treat low blood pressure. The most frequently used drug is phenylephrine which can administered along with oxytocin to prevent fall in blood pressure. This study will compare to different doses of Phenylephrine to prevent fall in blood pressure.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Patients having a placental abnormality

Patients taking beta-blocker and vasodilator therapy

Patients with hypertensive disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Phenylephrine bolus 75 micrograms

    Drug

    After delivery of Baby during C section, patient will be administered 3 IU of Oxytocin over 3 minutes along with 75 micrograms of Phenylephrine Intravenously.

  • Phenylephrine bolus 50 micrograms

    Drug

    After delivery of Baby during C section, patient will be administered 3 IU of Oxytocin over 3 minutes along with 50 micrograms of Phenylephrine Intravenously.

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: Phenylephrine 75Active comparator 1 intervention
Group B: Phenylephrine 50Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Hypotensive episodes

Hypotension will be defined as fall in Mean Arterial pressure by more than 20% from baseline value.

Time frame
Number of hypotensive episodes occuring upto 10 minutes after administration of Oxytocin and Phenylephrine

Secondary outcomes

1

Rescue Phenylephrine consumed

Time frame
This will be the total amount of Phenylephrine consumed to treat the hypotensive episodes occuring upto 10 minutes after administration of Oxytocin and Phenylephrine

Other outcomes

Sponsors and contacts

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