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

NCT03643913 | Completed Phase 4

• 1 other identifier: NS918
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Modified Leiden score

  the surgeon will be asked to score the surgical conditions on a five step scale based upon previously used scales: * grade 5: optimal surgical conditions, perfect access to the proximal humerus, glenohumeral joint and excellent visibility. * grade 4: good conditions: adequate surgical conditions to perform the surgery, but not optimal * grade 3: acceptable conditions, surgical procedure is jeopardized, but adequate surgical result is obtained, eventually after additional intervention * grade 2: poor conditions, exposure and handling hindered resulting in suboptimal surgical outcome * grade 1: extremely poor conditions, the surgeon is unable to work because of the inability to get access to the shoulder joint because of inadequate muscle relaxation.

  1 Day of surgery

• Visual analogue scale (VAS)

  Scale ranges from 0 to 10 representing respectively no pain and wordt imaginable pain.

  Day 3 post-operative at 14 o' clock

Secondary Outcomes (9)

• Muscular damage

  1 Day of surgery

• Muscular damage

  1 year after inclusion

• VAS

  The scoring will be done at 8-14 and 20 o'clock on days 1-3-5 post-operative and once a day from day 5 to day 30 post-operative.

• Analgesic needs

  Up to 5 days post-operative

• Analgesic needs

  From hospital discharge to 30 days post-operative

Study Arms (2)

Comparison group

ACTIVE COMPARATOR

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)

Procedure: Moderate neuromuscular block; Drug: Neuromuscular Blocking Agents and reversing agents

Deep group

EXPERIMENTAL

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)

Procedure: Deep neuromuscular block; Drug: Neuromuscular Blocking Agents and reversing agents

Interventions

Deep neuromuscular block 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).

Deep group

Moderate neuromuscular block 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).

Comparison group

Neuromuscular Blocking Agents and reversing agents DRUG

Deep neuromuscular block versus moderate neuromuscular block.

Comparison group; Deep group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• MSD Belgium BVBA: collaborator

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Neuromuscular Blocking Agents

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neuromuscular Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Harm Hoekstra, Prof. Dr.

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The patient and the surgeon are blinded for the intervention. The anesthesist knows the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Harm Hoekstra

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 23, 2018
• Study Start: December 18, 2018
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)