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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03248817
Other study ID # N-87-2017
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 28, 2017
Est. completion date May 25, 2020

Study information

Verified date November 2019
Source Cairo University
Contact Ahmed Hasanin, Professor
Phone +201095076954
Email ahmedmohamedhasanin@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 255
Est. completion date May 25, 2020
Est. primary completion date May 15, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
single shot phenylephrine
a single shot of phenylephrine (1.5 mcg/Kg) will be administrated intravenously
fixed infusion phenylephrine
fixed infusion of phenylephrine will be administrated at a rate of 0.75 mcg/Kg/min.
variable infusion phenylephrine
Variable infusion of phenylephrine will be administrated at a starting rate of 0.75 mcg/Kg/min.
Bupivacaine
Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia

Locations

Country Name City State
Egypt Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Post-spinal anesthesia hypotension Defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus. 30 minutes after spinal anesthesia
Secondary Incidence of severe Post-spinal anesthesia hypotension Defined as percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading during the period from intrathecal injection to delivery of the fetus. 30 minutes after spinal anesthesia
Secondary Incidence of reactive hypertension Defined as percentage of patients with increased systolic blood pressure more than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus. 2 hours after spinal anesthesia
Secondary systolic blood pressure systolic blood pressure measured in mmHg 2 hours after spinal anesthesia
Secondary diastolic blood pressure diastolic blood pressure measured in mmHg 2 hours after subarachnoid block
Secondary heart rate number of heart beats per minute 2 hours after subarachnoid block
Secondary APGAR score APGAR score of the fetus 10 minutes after delivery
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