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Trial record 8 of 115 for:    Recruiting, Not yet recruiting, Available Studies | "Hip Fractures"

Hypobaric Lateral Spinal Anesthesia Versus General Anesthesia for the Hip Fracture Surgery (RACHYP)

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ClinicalTrials.gov Identifier: NCT03373864
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hip Fractures Procedure: Unilateral spinal anesthesia Procedure: General anesthesia Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypobaric Lateral Spinal Anesthesia Versus General Anesthesia: Hemodynamic Stability and Short Term Cardiovascular Complications in Elderly Patients Undergoing Hip Fracture Surgery.
Actual Study Start Date : January 11, 2018
Estimated Primary Completion Date : September 11, 2019
Estimated Study Completion Date : September 11, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Unilateral spinal anesthesia
In this arm, the patients will have a hypobaric lateral spinal anesthesia. Sedation can be added for the patients comfort.
Procedure: Unilateral spinal anesthesia
Unilateral spinal anesthesia with hypobaric local anesthesia allowing a lateralized anesthesia of the fractured limb.

Active Comparator: General anesthesia
In this arm, the patients will have a general anesthesia.
Procedure: General anesthesia
General anesthesia following the latest recommendations for elderly patients (SFAR 2017)




Primary Outcome Measures :
  1. Number of episode of severe intraoperative hypotension [ Time Frame: At Day 0 ]
    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.


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 30 days after surgery ]
  2. Myocardial injury after non cardiac surgery (MINS) occurence [ Time Frame: 3 days after surgery ]
    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.

  3. Acute kidney injury (AKI) occurence [ Time Frame: 3 days after surgery ]
    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.)

  4. Hemoglobin rate [ Time Frame: 1 day after surgery ]
    Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery

  5. Hemoglobin rate [ Time Frame: 3 days after surgery ]
    Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery

  6. Blood loss [ Time Frame: At Day 0 ]
    Intraoperative blood loss : quantity of blood in the suction container

  7. Quantity of ephedrine used during the intervention [ Time Frame: At Day 0 ]
    Quantity of ephedrine used during operative time and recovery room

  8. Quantity of noradrenaline used during the intervention [ Time Frame: At Day 0 ]
    Quantity of noradrenaline used during operative time and recovery room

  9. Number of episodes with a MAP < 65 mmHg for more than 12 minutes during operative time [ Time Frame: At Day 0 ]
  10. Total time with MAP < 65 mmHg for more than 12 minutes during operative time [ Time Frame: At Day 0 ]
  11. Hospitalisation time [ Time Frame: Up to 45 days after surgery ]
  12. Number of episode of severe hypotension in the recovery room. [ Time Frame: At Day 0 ]
    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.



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Every patient aged 70 years or more who undergoes urgent surgery for a traumatic hip fracture.

Exclusion Criteria:

  • Patients younger than 70 years of age
  • Pathological fractures or multiple trauma
  • Contraindications to spinal anesthesia:
  • allergy to the local anesthetic
  • patients treated by clopidogrel (Plavix®)
  • patients treated by oral anticoagulants: dabigatran (Pradaxa®), rivaroxaban (Xarelto®), or apixaban (Eliquis®).
  • Coagulation disorders: (Prothrombin Time < 50 %, or Partial Thromboplastin Time ratio > 1.5, or platelets < 80 G/L),
  • Local infection of the puncture site
  • hyperthermia (> 38.5°C)
  • agitated patients
  • patients included in another study
  • patients under judicial protection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373864


Contacts
Contact: Claire DELSUC, MD, PhD +33 4 72 11 69 44 claire.delsuc@chu-lyon.fr
Contact: Pascal MEURET, MD, PhD +33 4 72 11 68 08 pascal.meuret@chu-lyon.fr

Locations
France
Hôpital Edouard Herriot - Service d'Anesthésie-Réanimation Recruiting
Lyon, France, 69003
Contact: Claire DELSUC, MD, PhD    +33 4 72 11 69 44    claire.delsuc@chu-lyon.fr   
Contact: Pascal , MD, PhD    +33 4 72 11 68 08    claire.delsuc@chu-lyon.fr   
Principal Investigator: Claire DELSUC, MD, PhD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Claire DELSUC, MD, PhD Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03373864     History of Changes
Other Study ID Numbers: 69HCL17_0513
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Unilateral spinal anesthesia
general anesthesia
hemodynamic stability
MINS
hip fracture
elderly
AKI

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs