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Hemodynamic safety of isobaric levobupivacaine versus isobaric bupivacaine for subarachnoid anesthesia in patients over 65 years old undergoing hip fracture surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520970-21-00
Acronym
CoLeBu
Enrollment
150
Registered
2025-02-04
Start date
2018-06-14
Completion date
Unknown
Last updated
2025-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip fracture

Brief summary

Invasive systolic arterial pressure (PASI), invasive diastolic arterial pressure (PADI), invasive mean arterial pressure (PAMI), arterial oxygen saturation (SatO2) measured in %, heart rate (HR) measured in beats per minute (bpm), and partial oxygen saturation (SpO2%) measured in %.

Detailed description

Cardiac index (CI), peripheral vascular resistance (PVR), partial arterial oxygen pressure (PaO2), and partial arterial carbon dioxide pressure (PaCO2) measured in mmHg, pH, arterial lactate (Lc) measured in mmol/L, and arterial hemoglobin (Hb) measured in g/dL., Adverse events during surgery and up to 48 hours after the surgical procedure will include: cardiovascular and respiratory adverse events, associated with the surgical technique and with the anesthetic technique.

Interventions

DRUGLevobupivacaína Normon 5 mg/ml solución inyectable y para perfusión EFG
DRUGInibsacain 5 mg/ml + 0
DRUG005 mg/ml solución inyectable en cartucho

Sponsors

Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Invasive systolic arterial pressure (PASI), invasive diastolic arterial pressure (PADI), invasive mean arterial pressure (PAMI), arterial oxygen saturation (SatO2) measured in %, heart rate (HR) measured in beats per minute (bpm), and partial oxygen saturation (SpO2%) measured in %.

Secondary

MeasureTime frame
Cardiac index (CI), peripheral vascular resistance (PVR), partial arterial oxygen pressure (PaO2), and partial arterial carbon dioxide pressure (PaCO2) measured in mmHg, pH, arterial lactate (Lc) measured in mmol/L, and arterial hemoglobin (Hb) measured in g/dL., Adverse events during surgery and up to 48 hours after the surgical procedure will include: cardiovascular and respiratory adverse events, associated with the surgical technique and with the anesthetic technique.

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026