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

Universitaire Ziekenhuizen KU Leuven

Status and phase: Completed; Phase 4

Conditions: Shoulder Pain; Anesthesia

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03643913

NS918

Details and patient eligibility

About

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..

Enrollment: 52 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

Comparison group

Active Comparator group

Description:

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)

Treatment:

Procedure: Moderate neuromuscular block

Drug: Neuromuscular Blocking Agents and reversing agents

Deep group

Experimental group

Description:

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)

Treatment:

Drug: Neuromuscular Blocking Agents and reversing agents

Procedure: Deep neuromuscular block