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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | adrenaline 0,33 mg per litter |
|
| Group 2 | Experimental | adrenaline 1 mg per litter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adrenaline 0,33 Mg/mL Solution for Injection | Drug | adrenaline dosage |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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.) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Average blood pressure | The mean intraoperative blood pressure is the average of all measurements taken during the procedure. | Day 1 |
| Average heart rate | The mean intraoperative heart rate is the average of all measurements taken during the procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de l'Atlantique | Puilboreau | 17138 | France |
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Randomised, double-blind, prospective, multicentre study in two parallel groups of 85 patients comparing two concentrations of adrenaline in arthroscopic irrigation fluid (0.33 mg/L vs 1 mg/L
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| Adrenaline 1 Mg/mL Solution for Injection |
| Drug |
adrenaline dosage |
|
| 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. | 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. | 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. | Day 1 |
| Duration of intervention | The duration of the procedure is defined by the time between the beginning of the incision and the end of the suture. | Day 1 |
| Amount of saline used for the arthroscopic procedure (in litres) | Amount of saline used for the arthroscopic procedure (in litres) | Day 1 |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004837 | Epinephrine |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004364 | Pharmaceutical Preparations |
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