TIVA Versus Balanced Anesthesia on Muscle Mass in CRC Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGrigore T. Popa University of Medicine and Pharmacy
About this trial
This study is aimed at clarifying changes in body composition during the perioperative period and identifying risk factors for skeletal muscle mass loss in patients with colorectal cancer. The investigators will asess the impact of the type of anaesthesia (total intravenous anaesthesia/sevoflurane anaesthesia) for colorectal surgery on the muscle function and mass, which will be evaluated using ultrasound, dynamometry and bioimpedance.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
lack the capacity to consent
extremity amputation
paraplegia
diseases affecting the muscles (such as stroke, lower-limb immobilization from a plaster, neurodegenerative diseases, peripheral neuropathy or muscle dystrophy)
Trial design
Design model
Parallel
Treatments tested in this trial
total intravenous anaesthesia
Procedure/Surgeryevaluate the impact of the type of anaesthesia (total intravenous anaesthesia (TIVA)/sevoflurane anaesthesia) for colorectal surgery on the muscle function and mass
sevoflurane anaesthesia
Procedure/Surgeryevaluate the impact of the type of anaesthesia (total intravenous anaesthesia (TIVA)/sevoflurane anaesthesia) for colorectal surgery on the muscle function and mass
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: total intravenous anaesthesiaActive comparator 1 intervention
Group B: sevoflurane anaesthesiaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Ultrasonographic assessment of muscle mass
Ultrasonographic muscle assessment is standardised in the assessment of muscle according to the SARCUS (Sarcopenia through UltraSound) working group recommendations. Rectus femoris muscle will be evaluated at 50% distance between the anterior superior iliac spine and the superior pole of the patella, in a lying position with knees in 10°, for muscle thickness and muscle cross-sectional area (CSA). Three measurements will be taken for each data point, and the average value will be used for further analysis. The biceps brachii muscle will be evaluated at 50% distance acromioclavicular joint and the elbow crease, in a supine position. Muscle thickness can be easily defined as the maximal vertical distance between the superficial and deep fasciae.
Time frame
From enrollment to 5 days after surgery2
Muscle function assessment
Measuring grip strength is simple and inexpensive. Grip strength will be determined bilaterally. Each measurement will be performed three times on the left and right extremities with 20 seconds intervals between the measurements. The maximum measured value in kilograms will be used for analysis.
Time frame
From enrollment to 5 days after surgery3
Bioimpedance assessment of lean and fat tissue mass
The bioimpedance measurements will be performed by a trained operator according to the manufacturer's recommendations. The Body Composition Monitor provides a quantitative measure of lean tissue and fat tissue mass. In contrast to earlier bioimpedance methodologies, the bioimpedance spectroscopy expresses body composition as a three-compartment model, providing overhydration, lean tissue index (LTI), and fat tissue index (FTI), whereby LTI and FTI are the respective tissue masses normalized to height squared.
Time frame
From enrollment to 5 days after surgerySecondary outcomes
1
Hospital length of stay
Time frame
From enrollment to the patient discharge, up to 52 weeks2
Mortality
Time frame
28 and 90-day mortality after surgeryOther outcomes
1
Correlation
Correlation between muscle strength and muscle mass using dynamometry and echography and bioimpedance at different time points
Time frame
From enrollment to 5 days after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Grigore T. Popa University of Medicine and Pharmacy
Lead sponsor
Regional Institute of Oncology, Iasi, Romania
Collaborator
Source ClinicalTrials.gov