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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
EU CTIS ID: 2025-520970-21-00
What this study is testing
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).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.