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

Phase 4

Recruiting

• Conditions: Hip fracture

• Registration Number: 2025-520970-21-00
• Lead Sponsor: Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA, Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

Brief Summary

The primary objective of the study will be to compare the hemodynamic effects of isobaric levobupivacaine and isobaric bupivacaine, both in combination with fentanyl, in patients aged 65 years or older undergoing hip fracture surgery. This comparison will be based on invasive systolic arterial pressure (PASI), invasive diastolic arterial pressure (PADI), invasive mean arterial pressure (PAMI), arterial oxygen saturation (SatO2) measured in %, and heart rate (HR) measured in beats per minute (bpm).

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-02-04
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

Patients aged 65 years or older

Underwent hip fracture surgery

Eligible for intradural anesthesia with levobupivacaine and fentanyl or bupivacaine and fentanyl, as determined in the pre-anesthetic visit.

Physical status classified between I and IV according to the American Society of Anesthesiologists (ASA).

Weight > 40 kg and Height > 140 cm. Body mass index (BMI) < 50 kg/m²

Presence of cardiovascular, respiratory, renal, or endocrine-metabolic condition

Provided informed consent to participate in the study.

Exclusion Criteria

Uncontrolled arterial hypertension (non-invasive systolic blood pressure >180 mmHg and/or non-invasive diastolic blood pressure >110 mmHg).

Heart rate (HR) >120 bpm

Oxygen saturation (SpO2) <90% upon arrival at the operating room

Contraindications to neuraxial anesthesia, including: Patient refusal, Infection at or near the puncture site, Degenerative neuromuscular disease, Hypovolemia, Coagulopathy or anticoagulant treatment, Extreme morbid obesity or Increased intracranial pressure.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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 %.		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 Outcome Measures

Name	Time	Method
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.		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.		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.

Trial Locations

Locations (1)

Hospital Clinico Universitario De Valencia; 🇪🇸 Valencia, Spain

Hospital Clinico Universitario De Valencia

🇪🇸Valencia, Spain

Rosa Herrera Castro

Site contact

659205338

35606rhc@gmail.com