Trials Sponsors Conditions Drugs Pricing

Conditions

Shoulder Rotator Cuff Tendinitis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

Average blood pressure
Day 1
Average heart rate
Day 1
Significant changes in blood pressure
Day 1
Significant changes in heart rate
Day 1
Evolution of the pressures of the arthropump
Day 1
+2 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL

adrenaline 0,33 mg per litter

Drug: Adrenaline 0,33 Mg/mL Solution for Injection

Group 2

EXPERIMENTAL

adrenaline 1 mg per litter

Drug: Adrenaline 1 Mg/mL Solution for Injection

Interventions

Adrenaline 0,33 Mg/mL Solution for InjectionDrug

adrenaline dosage

Group 1

Adrenaline 1 Mg/mL Solution for InjectionDrug

adrenaline dosage

Group 2

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient over 18 years of age, having read and signed the consent form for participation in the study after a reflection period (approximately 15 minutes)
Patient with a rotator cuff pathology (subacromial impingement, long biceps tendinopathy or rotator cuff tendinopathy)

Sponsors & Collaborators

GCS Ramsay Santé pour l'Enseignement et la Recherche
Otherlead

Study Sites (1)

Clinique de l'Atlantique

Puilboreau, 17138, France

MeSH Terms

Interventions

InjectionsEpinephrineSolutions

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatechols

Enrollment

181 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 22, 2022

First Posted

June 30, 2022

Study Start

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Group 1

Group 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Group 1

Group 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations