Phenylephrine Infusion in Cesarean Delivery

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Cesarean Section Complications; Spinal Anesthesia

Treatments: Drug: variable infusion phenylephrine; Drug: fixed infusion phenylephrine; Drug: Bupivacaine; Drug: single shot phenylephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT03248817

N-87-2017

Details and patient eligibility

About

the investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop of reactive hypertension occurred) and single shot (1.5 mcg/Kg) phenylephrine

Full description

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Phenylephrine (PE) is the most popular vasopressor for prevention of post-spinal hypotension (PSH) during CD; however, the most appropriate protocol for PE administration is still unknown. The most common PE protocols used for prophylaxis against PSH are: single shot, fixed infusion, and variable infusion. A recent study reported that a dose of 1.5 mcg/Kg is the most suitable single-shot dose for prophylaxis. Another randomized controlled trial compared four doses of PE infusion and reported that 25 mcg/Kg/min and 50 mcg/Kg/min doses were the best doses for fixed infusion with accepted incidence of both PSH as well as reactive hypertension. Using variable infusion rate of PE had been recently introduced in another study with a starting dose of 0.75 mcg/Kg/min. The variable rate infusion showed very good results regarding PSH. In this study, the investigators will compare variable infusion of PE (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop if reactive hypertension occurred) and single shot protocol (1.5 mcg/Kg)

Enrollment: 255 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Full term
• Pregnant women
• Scheduled for cesarean delivery

Exclusion criteria

• Pre-eclampsia
• Eclampsia
• Hemorrhage
• Cardiac dysfunction
• Baseline low heart rate (below 60 bpm)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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255 participants in 3 patient groups

single shot

Experimental group

Description:

spinal anesthesia will be performed using intrathecal bupivacaine. Then, a single shot phenylephrine (1.5 ug/Kg) will be administered

Treatment:

Drug: single shot phenylephrine

Drug: Bupivacaine

fixed infusion

Active Comparator group

Description:

spinal anesthesia will be performed using intrathecal bupivacaine. Then, fixed infusion phenylephrine will be administered at a dose of (0.75 mcg/Kg/min). the infusion will stop if reactive hypertension occurred

Treatment:

Drug: Bupivacaine

Drug: fixed infusion phenylephrine

variable infusion

Active Comparator group

Description:

spinal anesthesia will be performed using intrathecal bupivacaine. Then, variable infusion phenylephrine will be administered at a starting dose of (0.75 mcg/Kg/min). the infusion will be titrated according to blood pressure

Treatment:

Drug: Bupivacaine

Drug: variable infusion phenylephrine