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The Effect of Deep Neuromuscular Block and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity in Shoulder Surgery Using a Deltopectoral Approach

NCT03643913 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-12-12

No results posted yet for this study

Summary

The study evaluates wether deep neuromuscular block during entire surgical procedure to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach results in less muscular damage to the deltoid muscle and therefore less post-operative pain and an earlier functional recovery..

Conditions

  • Shoulder Pain
  • Anesthesia

Interventions

PROCEDURE

Deep neuromuscular block

Deep neuromuscular block requiring higher doses of Esmeron to target a post tetanic count (PTC) of 1-2 and higher doses of Bridion to reverse the block (4mg/kg).

PROCEDURE

Moderate neuromuscular block

Normal neuromuscular block requiring dosis of Esmeron to target a train of four (TOF) count of max 2 and lower doses of Bridion to reverse the block (2mg/kg).

DRUG

Neuromuscular Blocking Agents and reversing agents

Deep neuromuscular block versus moderate neuromuscular block.

Sponsors & Collaborators

  • MSD Belgium BVBA

    collaborator INDUSTRY

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Harm Hoekstra, Prof. Dr. · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-18
Primary Completion
2024-11-27
Completion
2024-11-27

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03643913 on ClinicalTrials.gov