The addition of adrenaline to the arthroscopic irrigation serum is used during rotator cuff surgery to limit intraoperative bleeding and ensure a clear view. Two concentrations of adrenaline are commonly used in practice: 1mg/L or 0.33 mg/L. The aim of this study is to determine which of these two doses provides better clarity of the surgical field with less impact on the patient's cardiovascular parameters.
A prospective, randomised, double-blind, multicentre study in two parallel groups of 85 patients comparing two concentrations of adrenaline in the irrigation fluid of an arthroscopy (0.33 mg/L vs. 1 mg/L): Maximum duration of patient participation in the study = 1 day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
181
adrenaline dosage
adrenaline dosage
Clinique de l'Atlantique
Puilboreau, France
Clarity of the arthroscopic surgical field
The primary endpoint is the clarity of the arthroscopic surgical field assessed by the investigator at the end of the surgical procedure on a numerical scale of 0 to 10, where zero means total opacity throughout the procedure and ten means total clarity throughout the procedure.)
Time frame: Day 1
Average blood pressure
The mean intraoperative blood pressure is the average of all measurements taken during the procedure.
Time frame: Day 1
Average heart rate
The mean intraoperative heart rate is the average of all measurements taken during the procedure.
Time frame: Day 1
Significant changes in blood pressure
The analysis will compare the number of significant changes that occurred in each group and the number of patients per group with at least one significant change.
Time frame: Day 1
Significant changes in heart rate
The analysis will compare the number of significant changes that occurred in each group and the number of patients per group with at least one significant change.
Time frame: Day 1
Evolution of the pressures of the arthropump
The criteria considered in the analysis will be: the pressure set at the beginning of the procedure, the maximum pressure reached during the procedure and the number of transient hyperpressures requested during the procedure.
Time frame: Day 1
Duration of intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The duration of the procedure is defined by the time between the beginning of the incision and the end of the suture.
Time frame: Day 1
Amount of saline used for the arthroscopic procedure (in litres)
Amount of saline used for the arthroscopic procedure (in litres)
Time frame: Day 1