Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension
NCT ID: NCT03015857
Last Updated: 2017-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2017-01-31
2017-04-30
Brief Summary
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Detailed Description
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After spinal block, patients will be randomly allocated into one of two groups:
* Phenylephrine group (n=100)
* Norepinephrine group (n=100)
Patients who shows SBP above 140 mmHg or heart rate below 55 bpm after the first vasopressor dose will not receive the infusion. The infusion will stop if the SBP was above 140 mmHg or if the heart rate was below 55 bpm. Patients will be positioned in the supine position with left lateral tilt. Block success will be assessed using pinprick, patients with failed block will be excluded from the study. The highest sensory block level will be assessed after 5 minutes from intrathecal injection. Co-hydration will be continued till maximum of 1.5 litres.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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phenylephrine,
\- Phenylephrine group (n=100): will receive 100 mcg phenylephrine as a single bolus just after intrathecal injection of 10 mg bupivacaine plus 20 mcg fentanyl. The dose will be diluted in 5 mL and given over seconds. A continuous infusion with placebo (normal saline) will start after the first bolus.
phenylephrine
\- phenylephrine; a vasopressor drug given to prevent post spinal hypotension
Bupivacaine
intrathecal bupivacaine 10 mg will be given in both groups
Fentanyl
intrathecal fentanyl 20 mcg will be given in both groups
Placebo (normal saline)
norepinephrine
\- Norepinephrine group (n=100): will receive bolus of norepinephrine (10 mcg) directly after spinal block using 10 mg bupivacaine plus 20 mcg fentantanyl followed by continuous infusion of norepinephrine with a rate of 0.1 mcg/kg/min till delivery of the fetus.
Norepinephrine
\- norepinephrine; a vasopressor drug given to prevent post spinal hypotension
Bupivacaine
intrathecal bupivacaine 10 mg will be given in both groups
Fentanyl
intrathecal fentanyl 20 mcg will be given in both groups
Interventions
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phenylephrine
\- phenylephrine; a vasopressor drug given to prevent post spinal hypotension
Norepinephrine
\- norepinephrine; a vasopressor drug given to prevent post spinal hypotension
Bupivacaine
intrathecal bupivacaine 10 mg will be given in both groups
Fentanyl
intrathecal fentanyl 20 mcg will be given in both groups
Placebo (normal saline)
Eligibility Criteria
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Inclusion Criteria
* elective cesarean sections
Exclusion Criteria
* hypertensive disorders of pregnancy
* peripartum bleeding
* body mass index \> 35 will be excluded from the study
18 Years
35 Years
FEMALE
No
Sponsors
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Kasr El Aini Hospital
OTHER
Responsible Party
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ahmed elsakka
Principal investigator and lecturer of anesthesia, faculty of medicine cairo university
Principal Investigators
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Shereen Refaat, M.D.
Role: STUDY_CHAIR
Lecturer of anesthesia Faculty of medicine Cairo university
Tamer M Rook, M.D.
Role: STUDY_CHAIR
Lecturer of anesthesia Faculty of medicine Cairo university
Other Identifiers
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cesarean sections
Identifier Type: -
Identifier Source: org_study_id
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