Hip fracture is a frequent pathology, involving elderly patients with many co-morbidities ; therefore, post-operative morbidity and mortality is high. It is reported that intra-operative hemodynamics correlate with post-operative complications such as myocardial injury after non-cardiac surgery (MINS) or acute kidney injury (AKI) ; that is why elderly patients undergoing hip fracture surgery should benefit from a better hemodynamic stability. Low-dose hypobaric lateral spinal anesthesia with a reduced dose of local anesthetic has been shown to have better hemodynamic stability than conventional spinal anesthesia. It has also been reported that general anesthesia and conventional spinal anesthesia in elderly patients undergoing hip fracture surgery have the same hemodynamic effect. However, no published study has compared low-dose hypobaric lateral spinal anesthesia to general anesthesia with regards to hemodynamic effects. The aim of the present study is to compare the intra-operative hemodynamics of low-dose hypobaric lateral spinal anesthesia with that of general anesthesia in elderly patients undergoing hip fracture surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
Unilateral spinal anesthesia with hypobaric local anesthesia allowing a lateralized anesthesia of the fractured limb.
General anesthesia following the latest recommendations for elderly patients (SFAR 2017)
Hôpital Edouard Herriot - Service d'Anesthésie-Réanimation
Lyon, France
Number of episode of severe intraoperative hypotension
Occurrence of an episode of severe hypotension defined as a mean arterial pressure (MAP) \< 65 mmHg for more than 12 minutes during the operative time.
Time frame: At Day 0
All-cause mortality
Time frame: 30 days after surgery
Myocardial injury after non cardiac surgery (MINS) occurence
Elevated troponin T level (troponin T \> 100 ng/L) in aged patients (over 75 years) and for patients under the age of 75 years old Troponin T\> 34 ng/L for men and troponin T \> 16 ng / L for women, in a blood test performed in the first 3 days after surgery due to a myocardial ischemia.
Time frame: 3 days after surgery
Acute kidney injury (AKI) occurence
Postoperative AKI is defined as an increase in serum creatinine between preoperative and postoperative values (increase of more than 1.5-fold or more than 0.3mg/dL of the value before surgery.)
Time frame: 3 days after surgery
Hemoglobin rate
Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery
Time frame: 1 day after surgery
Hemoglobin rate
Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery
Time frame: 3 days after surgery
Blood loss
Intraoperative blood loss : quantity of blood in the suction container
Time frame: At Day 0
Quantity of ephedrine used during the intervention
Quantity of ephedrine used during operative time and recovery room
Time frame: At Day 0
Quantity of noradrenaline used during the intervention
Quantity of noradrenaline used during operative time and recovery room
Time frame: At Day 0
Number of episodes with a MAP < 65 mmHg for more than 12 minutes during operative time
Time frame: At Day 0
Total time with MAP < 65 mmHg for more than 12 minutes during operative time
Time frame: At Day 0
Hospitalisation time
Time frame: Up to 45 days after surgery
Number of episode of severe hypotension in the recovery room.
Occurrence of an episode of severe hypotension defined as a mean arterial pressure (MAP) \< 65 mmHg for more than 12 minutes in the recovery room.
Time frame: At Day 0
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