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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unilateral spinal anesthesia | Experimental | In this arm, the patients will have a hypobaric lateral spinal anesthesia. Sedation can be added for the patients comfort. |
|
| General anesthesia | Active Comparator | In this arm, the patients will have a general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unilateral spinal anesthesia | Procedure | Unilateral spinal anesthesia with hypobaric local anesthesia allowing a lateralized anesthesia of the fractured limb. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 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. |
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Inclusion Criteria:
- Every patient aged 70 years or more who undergoes urgent surgery for a traumatic hip fracture.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire DELSUC, MD, PhD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Edouard Herriot - Service d'Anesthésie-Réanimation | Lyon | 69003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36135347 | Result | Simonin M, Delsuc C, Meuret P, Caruso L, Deleat-Besson R, Lamblin A, Huriaux L, Abraham P, Bidon C, Giai J, Riche B, Rimmele T. Hypobaric Unilateral Spinal Anesthesia Versus General Anesthesia for Hip Fracture Surgery in the Elderly: A Randomized Controlled Trial. Anesth Analg. 2022 Dec 1;135(6):1262-1270. doi: 10.1213/ANE.0000000000006208. Epub 2022 Sep 22. |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| General anesthesia | Procedure | General anesthesia following the latest recommendations for elderly patients (SFAR 2017) |
|
| 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.) | 3 days after surgery |
| Hemoglobin rate | Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery | 1 day after surgery |
| Hemoglobin rate | Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery | 3 days after surgery |
| Blood loss | Intraoperative blood loss : quantity of blood in the suction container | At Day 0 |
| Quantity of ephedrine used during the intervention | Quantity of ephedrine used during operative time and recovery room | At Day 0 |
| Quantity of noradrenaline used during the intervention | Quantity of noradrenaline used during operative time and recovery room | At Day 0 |
| Number of episodes with a MAP < 65 mmHg for more than 12 minutes during operative time | At Day 0 |
| Total time with MAP < 65 mmHg for more than 12 minutes during operative time | At Day 0 |
| Hospitalisation time | 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. | At Day 0 |
| D007869 |
| Leg Injuries |