Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03843970 |
Other study ID # |
CoLeBu |
Secondary ID |
|
Status |
Recruiting |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
June 14, 2018 |
Est. completion date |
July 31, 2023 |
Study information
Verified date |
March 2022 |
Source |
Hospital Clínico Universitario de Valencia |
Contact |
HERRERA Rosa, PhD |
Phone |
+34 659205338 |
Email |
35606rhc[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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