Status:
UNKNOWN
Hemodynamic Safety of Levobupivacaine vs Bupivacaine in Patients Over 65 Years Undergoing Hip Surgery
Lead Sponsor:
Hospital Clínico Universitario de Valencia
Conditions:
Hip Fractures
Hemodynamic Stability
Eligibility:
All Genders
65-120 years
Phase:
PHASE4
Brief Summary
The altered hemodynamics, and therefore the arterial hypotension is the most prevalent adverse effect after subarachnoid anesthesia. The objective of the study was to determine the exact role of local...
Detailed Description
1. Objective of the trial 1.1. Main objective: Compare the hemodynamic effects from invasive systolic diastolic and mean blood pressures (ISBP, IDBP and IMBP) mesured in mmHg, arterial partial pressur...
Eligibility Criteria
Inclusion
- Men and Women over 65 years
- Who meet the requirements in the pre-anesthetic to be treated with spinal anesthesia with levobupivacaine or bupivacaine, both with fentanyl,
- Fitness: from I to IV, according to the American Society of Anesthesiologists (ASA),
- Weight\> 40 kg,
- Height\> 140 cm,
- Body mass index (BMI) \<50 kg/m2,
- Pathology cardiovascular, respiratory, renal and endocrine-metabolic,
- Provide written informed consent
Exclusion
- Patients with uncontrolled hypertension (non-invasive systolic blood pressure\> 180 mmHg and / or non-invasive diastolic blood pressure \> 110mmHg),
- HR\> 120 bpm,
- SpO2 \<90% on arrival in the operating room and the contraindication to perform neuraxial anesthesia (patient refusal, infection at the site of puncture or lancing different, neuromuscular degenerative disease, hypovolemia, coagulopathy or anticoagulant therapy, morbid obesity, and extreme increase in intracranial pressure).
Key Trial Info
Start Date :
June 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03843970
Start Date
June 14 2018
End Date
July 31 2023
Last Update
March 31 2022
Active Locations (1)
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1
Hospital Clínico Universitario
Valencia, Spain, 46010