NCT03843970

Hemodynamic Safety of Levobupivacaine vs Bupivacaine in Patients Over 65 Years Undergoing Hip Surgery

Hemodynamic Safety of Isobaric Levobupivacaine Versus Isobaric Bupivacaine for Subarachnoid Anesthesia in Patients Over 65 Years Undergoing Hip Surgery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Hospital Clínico Universitario de Valencia · Academic / Other
• Sex: All
• Age: 65 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

The altered hemodynamics, and therefore the arterial hypotension is the most prevalent adverse effect after subarachnoid anesthesia. The objective of the study was to determine the exact role of local anesthetic selection underlying spinal anesthesia-induced hypotension in the elderly patient. We conducted a descriptive, interventional pilot study to assess the hemodynamic impact of subarachnoid anesthesia with isobaric levobupivacaine versus isobaric bupivacaine for hip fracture surgery.

Detailed description

1. Objective of the trial 1.1. Main objective: Compare the hemodynamic effects from invasive systolic diastolic and mean blood pressures (ISBP, IDBP and IMBP) mesured in mmHg, arterial partial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg , arterial oxygen saturation (SatO2) measured in%, heart rate (HR / bpm) measured in beats per minute. Other variables of interest will be: cardiac index (CI) mesured in litres per minute per square metre (L/min/m2), peripheral vascular resistance (PVR) medured in dynes/seconds/cm-5, partial arterial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg, pH (pH), arterial lactate (Lc) measured in mmol / L, arterial hemoglobin (Hb) measured in g/dl, partial oxygen saturation (SpO2%) measured in %. 1.2. Secondary objectives: Assess potential adverse events during surgery and 48 hours of surgery. Adverse events include adverse cardiovascular and respiratory rate, events related to both surgical and anesthetic techniques and exitus. 2. End points 2.1. Primary end point(s): hemodynamic variables invasive systolic blood pressure (ISBP) measured in mmHg invasive diastolic blood pressure (ISBP), measured in mmHg invasive mean blood pressure (IMBP), measured in mmHg arterial partial pressure of oxygen (PaO2) arterial partial pressure of carbon dioxide (PaCO2), measured in mmHg arterial oxygen saturation (SatO2) measured in% heart rate (HR / bpm) measured in beats per minute cardiac index (CI) mesured in litres per minute per square metre (L/min/m2). peripheral vascular resistance (PVR) mesured in dynes/seconds/cm-5 partial arterial pressure of oxygen (PaO2) measured in mmHg arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg pH (pH) arterial lactate (Lc) measured in mmol / L arterial hemoglobin (Hb) measured in g / dl partial oxygen saturation (SpO2%) measured in %. 2.1.1 Timepoint(s) of evaluation of this end point: entry into the operating room, after 30 minutes of anesthesia and at the end of anesthesia. 2.2. 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). 2.2.1. Timepoint(s) of evaluation of this end point: 48 hours of surgery

Conditions

• Hip Fractures
• Hemodynamic Stability

Interventions

Type	Name	Description
DRUG	Levobupivacaine Hydrochloride 0.5%	The solution is called L solution, which contains a combination of 0.5% isobaric levobupivacaine with fentanyl. Injectable Solution.
DRUG	Isobaric bupivacaine 0.5%	The solution is called B solution, which contains a combination of 0.5% isobaric bupivacaine with fentanyl. Injectable Solution.

Timeline

• Start date: 2018-06-14
• Primary completion: 2023-05-31
• Completion: 2023-07-31
• First posted: 2019-02-18
• Last updated: 2022-03-31

Locations

1 site across 1 country: Spain