The Effect of Deep Neuromuscular Block and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity in Shoulder Surgery Using a Deltopectoral Approach
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Modified Leiden score
研究概览
简要总结
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..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The patient and the surgeon are blinded for the intervention. The anesthesist knows the allocation.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patient undergoing elective or semi-elective surgery to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Moderate neuromuscular block (Procedure)
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)
干预措施: Neuromuscular Blocking Agents and reversing agents (Drug)
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)
干预措施: Deep neuromuscular block (Procedure)
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)
干预措施: Neuromuscular Blocking Agents and reversing agents (Drug)
结局指标
主要结局
Modified Leiden score
时间窗: 1 Day of surgery
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.
Visual analogue scale (VAS)
时间窗: Day 3 post-operative at 14 o' clock
Scale ranges from 0 to 10 representing respectively no pain and wordt imaginable pain.
次要结局
- 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.)
- Length of stay(from day 3 up to 3 weeks after surgery)
- Evaluation of dry catheter technique(1 Day of surgery)
- Analgesic needs(From hospital discharge to 30 days post-operative)
- Length of stay at post-anesthesia care unit (PACU)(1 Day of surgery)
- Length of surgery(intraoperative)
研究者
Harm Hoekstra, prof. dr.
Prof. Dr. Harm Hoekstra
Universitaire Ziekenhuizen KU Leuven