In patients 65 years or older undergoing hip surgery. MedDRA version: 20.0 Level: PT Classification code 10051060 Term: Hip surgery System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Levobupivacaine Kabi 5 mg/ml
Product Name: levobupivacaine 0.5%
Product Code: levobupivacaine 0.5%
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: LEVOBUPIVACAINE
Sponsors
ROSA HERRERA CASTRO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: men and women 65 years or older, who meet the requirements in the pre-anesthetic to be treated with spinal anesthesia with levobupivacaine and bupivacaine and fentanyl or fentanyl, fitness: from I to IV, according to the American Society of Anesthesiologists (ASA), weight> 40 kg, height> 140 cm, body mass index (BMI) =65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: Patients with uncontrolled hypertension (systolic blood pressure values ??noninvasive> 180 mmHg and / or diastolic blood pressure noninvasively> 110mmHg), HR> 120 bpm, SpO2 <90% on arrival in the operating room and with contraindications to the realization neuraxial anesthesia (patient refusal, infection at the site of puncture or lancing different, neuromuscular degenerative disease, hypovolemia, coagulopathy or anticoagulant therapy, and morbid obesity extreme increase in intracranial pressure).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the hemodynamic effects from the systolic blood pressure values ??invasive (PASI) and invasive diastolic blood pressure (PADI), arterial partial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2), measured in mmHg , arterial oxygen saturation (SatO2) misobaric easured in%, pH (pH), blood hemoglobin (Hb) measured in g / dL, heart rate (HR / bpm) measured in beats per minute, oxygen saturation (SpO2 %) measured in% and hourly diuresis (D / h) measured in ml / h of isobaric levobupivacaine and isobaric bupivacaine both with fentanyl in combination, in patients 65 years or older undergoing hip surgery.;Secondary Objective: Assess potential adverse events during surgery and 48 hours of surgery. Adverse events include adverse cardiovascular and respiratory rate from the use of levobupivacaine and bupivacaine isobariric , events related to both surgical and anesthetic techniques and exitus .;Primary end point(s): hemodynamic variables invasive systolic blood pressure (PASI) measured in mmHg invasive diastolic blood pressure (PADI), measured in mmHg heart rate (Fc / lpm), measured in beats per minute partial oxygen saturation (SpO2%) measured in% hourly diuresis (D / h), measured in ml / h;Timepoint(s) of evaluation of this end point: entry into the operating room, 30 minutes to the end of anesthesia | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A. Intraoperative adverse events: 1) Cardiovascular and Respiratory: Venous air embolism (VAE), deep vein thrombosis (DVT), myocardial infarction (AMI), cerebrovascular accident (CVA), congestive heart failure (CHF), pneumonia (N), Exitus (Ex) 2) Other: Acute renal failure (ARF), vomiting (V) 3) Associated with the surgical technique: RBC transfusion (Th), plasma transfusion (TPL), nerve damage (ln), femur fracture (Fx f) 4) Associated with the anesthetic technique: paresthesia (pair), hematic puncture (ph), other B.Postoperative adverse events (at 48 hours) 1) Cardiovascular and Respiratory: Deep vein thrombosis (DVT), myocardial infarction (AMI), cerebrovascular accident (CVA), congestive heart failure (CHF), pneumonia (N), Exitus (Ex) 2) Other: Acute renal failure (ARF), UTI (Infu), vomiting (V). 3) Associated with the surgical technique: RBC transfusion (Th), plasma transfusion (TPL), neurologic deficit (defnq), surgical wound infection (Infhq). 4) Associated with the anesthetic technique: neurological deficit (defn), postdural puncture headache (PDPH), back pain (Lumb).;Timepoint(s) of evaluation of this end point: 48 hours from surgery | — |
Countries
Spain
Contacts
Public ContactROSA HERRERA
ROSA HERRERA CASTROS
Outcome results
None listed