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Orthopedic Surgery of Lower Limb | Prophylactic Phenylephrine Infusion for Preventing Hypotension During Spinal Anesthesia

Orthopedic Surgery of Lower Limb research study

What is the primary objective of this study?

Lower limb orthopedic surgery is commonly realized under spinal anesthesia. This loco-regional anesthesia induces a peripheral vascular resistance decrease by vasodilatation resulting in hypotension. A severe and prolonged hypotension can compromise regional perfusion and worse outcome especially in very elderly patients. Moreover the venous vasodilatation observed after spinal anesthesia decreases cardiac preload resulting in a cardiac output decrease. Several authors had identified the prevention of hypotension as a key role during spinal anesthesia although none prophylactic treatment has been identified. Spinal anesthesia single injection (SA) with low dose of local anesthetic or continuous spinal anesthesia with very low dose bolus injections cause fewer episodes of hypotension. Despite these techniques, hypotension can occur. Phenylephrine is an alpha adrenergic agonist and cause vasoconstriction preventing hypotension. Prophylactic phenylephrine infusion for preventing hypotension has been demonstrated during spinal anesthesia for cesarean delivery. The investigators want to assess for the first time the prophylactic phenylephrine infusion for preventing hypotension in elderly patients undergoing orthopedic lower limb surgery under spinal anesthesia single injection.

Who is eligible to participate?

Inclusion Criteria: - over 60 years old - informed consent - lower limb orthopaedic surgery - spinal anesthesia Exclusion Criteria: - dementia - anemia less than 10grams per deciliter - hypertension - hemostasis disorders - infection at the puncture - allergy to local anesthetic, - patient under anticoagulant.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Orthopedic Surgery of Lower Limb

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:phenylephrine infusionpatients from 60 to 75 years receiving 100micrograms of phenylephrine infusion

Drug:patients receiving saline infusionpatients more than 60 years receiving 100micrograms of saline infusion

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

phenylephrinepatients more than 60 years receiving 100micrograms of phenylephrine infusion (2 groups 60-75 years and more than 75 years)

placebopatients more than 60 years receiving saline infusion (2 groups 60-75 years and more than 75)

Study Status

Completed

Start Date: March 2011

Completed Date: September 2013

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: number of hypotension episodes

Secondary Outcome: number of episodes of severe hypotension

Study sponsors, principal investigator, and references

Principal Investigator: Vincent Minville, PhD

Lead Sponsor: University Hospital, Toulouse

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01533662

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