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

NCT ID: NCT03643913

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-18
• Study Completion Date: 2024-11-27

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Comparison group

Neuromuscular Blocking Agents and reversing agents: The comparison group will receive anesthesia top up Esmeron dose to maintain a Train Of Four (TOF) count of maximum 2 during the whole procedure. This represents moderate neuromuscular block conditions. A neuromuscular monitor (PHILIPS integrated) will be used to evaluate TOF count.

To maintain TOF at 2 and according to our practice a bolus injection of 0,1 mg/kg Rocuronium will be given when TOF count returns to 3. This dose will be repeated if TOF does not go back to 2 within 2 minutes after bolus injection. TOF guard and TOF tube will be used at the ulnar nerve at the contralateral side and will be checked continuously during surgery.

Reversal of the TOF=2 will be done by Sugammadex 2 mg/kg at end of procedure (Time of last suture)

Group Type: ACTIVE_COMPARATOR

Moderate neuromuscular block

Intervention Type: PROCEDURE

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).

Neuromuscular Blocking Agents and reversing agents

Intervention Type: DRUG

Deep neuromuscular block versus moderate neuromuscular block.

Deep group

Neuromuscular Blocking Agents and reversing agents: The deep group will receive deep neuromuscular block, using a infusion of Esmeron at 0,1mg/kg/hour. A post tetanic count will be performed and our target will be to have a PTC 1-2. The standard infusion will be adjusted as such. Reversal will be achieved by Sugammadex 4 mg/kg depending on reversal speed at the end of procedure (Time of last suture)

Group Type: EXPERIMENTAL

Deep neuromuscular block

Intervention Type: PROCEDURE

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).

Neuromuscular Blocking Agents and reversing agents

Intervention Type: DRUG

Deep neuromuscular block versus moderate neuromuscular block.

Interventions

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).

Intervention Type: 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).

Intervention Type: PROCEDURE

Neuromuscular Blocking Agents and reversing agents

Deep neuromuscular block versus moderate neuromuscular block.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patient undergoing elective or semi-elective surgery to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach

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 Anaesthesiologists (ASA) physical status >II
• Age <18 or >85 year 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
• Pregnancy
• Breastfeeding
• Predicted difficult airway
• Patients receiving medications known to interact with neuromuscular blocking agents
• Allergy to any drug included in the anesthetic protocol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MSD Belgium BVBA

INDUSTRY

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Harm Hoekstra, prof. dr.

Prof. Dr. Harm Hoekstra

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harm Hoekstra, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

Other Identifiers

NS918

Identifier Type: -

Identifier Source: org_study_id