Orthopedic Surgery of Lower Limb Clinical Trial
Official title:
Phase 2 Study Evaluating the Prophylactic Phenylephrine Infusion for Preventing Hypotension During Spinal Anesthesia for Lower Limb Orthopedic Surgery in the Elderly Patients
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.
The aim of this study is to assess the prophylactic phenylephrine infusion for preventing
hypotension in elderly patients.
This prospective double blinded randomized control trial will include elderly patients over
60 years undergoing orthopedic lower limb surgery under spinal anesthesia single injection
(10 mg of Bupivacaine 0,5% with 5 µg of Sufentanyl). We define 4 groups: (1) Patients from
60 to 75 years receiving 100 µg/min of phenylephrine infusion; (2) patients from 60 to 75
years receiving saline infusion; (3) patients over 75 years receiving 100 µg/min of
phenylephrine infusion; (4) patients over 75 years receiving saline infusion. Standard
monitoring is applied including noninvasive arterial blood pressure, electrocardiography and
pulse oximetry. The vasopressor solution and the saline solution will be prepared in
identical 50 mL syringes by an investigator not involved in patient care. The investigator
administering the solution and the patient are blinded to the content of the syringe. The
velocity of infusion will be the same between groups (1ml/min) and the infusion will start
once the spinal anesthesia realized. Arterial blood pressure measurements are realized each
1 minute for the first 20 minutes and then each 5 minutes until the end of surgery. After
each measurement of MAP, the infusion is stopped if the MAP is more than baseline, and it is
continued or restarted if the MAP is less than or equal to baseline. Anyway the infusion is
stopped at the end of motor block. Hypotension is defined as a 20% decrease of mean arterial
pressure (MAP). Severe hypotension is defined as a 30% decrease of MAP. Hypertension is
defined as MAP > 120% of baseline. Each time there is a MAP measurement showing hypotension
while patients are under infusion, a 1 mL IV bolus of phenylephrine 100µg/ml is injected by
the anesthesiologist involved in patient care. The total volume of study solution given by
infusion and the total volume of phenylephrine given by bolus are recorded.
We want to demonstrate fewer episodes of hypotension and fewer post operatory cardiovascular
and neurologic events in the groups receiving prophylactic phenylephrine infusion.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention