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Prophylactic Phenylephrine Infusion in Elderly Orthopedic Surgery
NCT01533662Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2011
- Primary completion
- May 2013
- Countries
- 1
- Sponsor
- Centre hospitalier universitaire de Toulouse
- Modality
- Small Molecules
- Drugs
- phenylephrine
- Conditions
- hypotension
01
Overview
Phase 2, randomised, double-blind trial of phenylephrine in hypotension (4 arms), sponsored by Centre hospitalier universitaire de Toulouse. Primary endpoint: Number of hypotension episodes at 48 hours. Started Mar 2011; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Phenylephrine (60-75)
Patients 60-75 years receiving phenylephrine infusion.
Placebo (60-75)
Patients 60-75 years receiving saline infusion.
Phenylephrine (>75)
Patients >75 years receiving phenylephrine infusion.
Placebo (>75)
Patients >75 years receiving saline infusion.
03
Who it enrols
Elderly patients (>60 years) undergoing orthopedic lower limb surgery under spinal anesthesia, excluding those with dementia, anemia (<10g/dL), hypertension, hemostasis disorders, infection at puncture site, allergy to local anesthetic, or on anticoagulants.
04
Endpoints
Primary
Number of hypotension episodes
Secondary
Number of episodes of severe hypotension
Cardiovascular events
Neurologic events
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