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Clinical Trials/EUCTR2018-002961-21-BE
EUCTR2018-002961-21-BE
Active, not recruiting
Phase 1

The effect of deep neuromuscular block and reversal with sugammadex on surgical conditions and perioperative morbidity in shoulder surgery using a deltopectoral approach

Z Leuven0 sites52 target enrollmentSeptember 21, 2018
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ConditionsSubject undergoing elective or semi-elective surgery to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
DrugsEsmeronBridion

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Subject undergoing elective or semi-elective surgery to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach.
Sponsor
Z Leuven
Enrollment
52
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 21, 2018
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Z Leuven

Eligibility Criteria

Inclusion Criteria

  • •18 years or older at enrollment
  • •Subjects who are undergoing elective or semi\-elective surgery to the gleno\-humeral joint or the proximal humerus using a deltoideo\-pectoral approach
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 43
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 9

Exclusion Criteria

  • •Inability to consent because of mental status
  • •Open injuries involving the deltoid muscle
  • •Previous open surgery on the shoulder joint
  • •American Society of Anesthesiologists (ASA) physical status \> II
  • •Age \< 18 or \> 75 years old
  • •Body mass index (BMI) \<18,5 or \> 35 kg/m²
  • •Renal insufficiency: glomerular filtration rate \< 40 ml/min
  • •Impaired liver function: hepatic cirrhosis, cholestatic jaundice
  • •Neuromuscular disease
  • •Pregnant female subjects

Outcomes

Primary Outcomes

Not specified

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