Hemodynamic safety of isobaric levobupivacaine versus isobaric bupivacaine for spinal anesthesia in patients over 65 years, underwent hip surgery.

Phase 1

• Conditions: In patients 65 years or older undergoing hip surgery.; MedDRA version: 20.0Level: PTClassification code 10051060Term: Hip surgerySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-003113-26-ES
• Lead Sponsor: ROSA HERRERA CASTRO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-09
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

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) <50 kg/m2, pathology
cardiovascular, respiratory, renal and endocrine-metabolic to give their informed consent for participation in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified