Clinique de l'Atlantique
Puilboreau, 17138, France
NCT Number: NCT05439213
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Puilboreau, 17138, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
adrenaline dosage
adrenaline dosage
Time frame: Day 1
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
The mean intraoperative blood pressure is the average of all measurements taken during the procedure.
Time frame: Day 1
The mean intraoperative heart rate is the average of all measurements taken during the procedure.
Time frame: Day 1
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
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
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
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)
GCS Ramsay Santé pour l'Enseignement et la Recherche
Other
Comparison of the Effects of Two Concentrations of Adrenaline (0.33 mg/l vs 1 mg/l) in the Irrigation Serum of Arthroscopic Shoulder Surgery.
Acronym: PINHAR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.