The Effects of Deep Neuromuscular Blockade During Robot-assisted Transaxillary Thyroidectomy on Postoperative Pain and Sensory Change

Study Overview
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Brief Summary
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As robotic surgery has been applied to various surgeries, the minimally invasive surgery is rapidly evolving. In particular, robot-assisted thyroidectomy is one of the leading techniques in minimally invasive surgery fields. Robot-assisted transaxillary thyroidectomy dramatically improves the cosmetic satisfaction, showing no difference in cancer control and safety comparing with conventional open thyroidectomy. However, some studies have shown that many patients complained of chest pain after robot-assisted thyroidectomy, and about 20% of patients suffered chronic pain even after three months of surgery. This might be due to the flap formation during robot-assisted thyroidectomy. Robot-assisted transaxillary thyroidectomy does not provide visibility by injecting CO2. But it provides visibility using Chung's retractor system to make a flap between the pectoralis major muscle and subcutaneous fat layer. The flap is formed from the incision of axilla to the anterior neck to approach the thyroid gland. In this progress, it requires considerable force to maintain the Chung's retractor system, and additional pressure may be applied to the subcutaneous fat and skin constituting the skin flap. The pressure applied to the skin flap may be associated with postoperative pain and sensory abnormality, but it has not been studied yet. Deep neuromuscular blockade The neuromuscular block for muscle relaxation during surgery is essential for general anesthesia. In general, a neuromuscular block agent is used to induce intubation during induction of anesthesia. Continuous or single injection of neuromuscular block agent is then carried out as needed during the operation. The effect of deep neuromuscular blockade on laparoscopic surgery using carbon dioxide has already been studied. Deep neuromuscular blockade on laparoscopic surgery reduced postoperative pain and improved the surgical condition compared to conventional moderate neuromuscular blockade. However, the effect of neuromuscular blockade on robot-assisted thyroid surgery has not been studied yet. There was concern about delayed recovery of muscle relaxation and respiratory failure due to deep neuromuscular blockade. However, the development of sugammadex (Bridion, Merck Sharp and Dohme - MSD, Oss, Netherlands) eliminated these concerns. Sugammadex dramatically reduced the recovery time from deep neuromuscular blockade.

Official Title
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The Effects of Deep Neuromuscular Blockade During Robot-assisted Transaxillary Thyroidectomy on Postoperative Pain and Sensory Change; Prospective Randomized Control Trial

Conditions
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Thyroid Neoplasms

Intervention / Treatment
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* Drug: Deep Group
* Drug: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A. 20-70 yrs old patients scheduled for robot-assisted transaxillary thyroidectomy B. ASA(American Society of Anesthesiologists) classification: Ⅰ-Ⅲ C. Patients who voluntarily agree to participate in this clinical study. Exclusion Criteria: A. Patients scheduled for radical neck node dissection B. Patients scheduled for co-operation of other organs or Patients with other accompanying cancers C. Patients with BMI(Body Mass Index) > 30 kg/m2 D. Patients with history of Liver failure, Renal failure E. Patients who already have pain or paresthesia on chest, axilla, or neck. F. Patients with history of allergy to rocuronium or sugammadex G. Patients who cannot read the consent form (examples: Illiterate, foreigner) H. Pregnant woman, Lactating woman

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Deep group Continuous rocuronium infusion during surgery Maintain TOF = 0 & PTC= 1 2 (Deep neuromuscular block) Control group Continuous rocuronium infusion during surgery Maintain TOF 1 2 (Moderate neuromuscular block)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep Block Group<br>Continuous Rocuronium infusion during surgery Maintain TOF = 0 & PTC= 1 2 At the end of surgery, IV Sugammadex injection to reverse muscle relaxation. (Sugammadex dose = 2mg/kg at TOF ≥2 or 4mg/kg at TOF < 2) | Drug: Deep Group<br>* Continuous Rocuronium (Rocnium®, Hanlim Pharm. Co., Ltd., South Korea) infusion during surgery Titrate Rocuronium (Rocnium®) infusion rate to maintain TOF = 0 & PTC= 1 2 (TOF = train-of-four. PTC = post-tetanic count) TOF and PTC are assessed by acceleromyography (TOF-Watch® SX, Organon Ltd., Drynam Road, Swords, Co. Dublin, Ireland). At the end of surgery, IV Sugammadex (Bridion®, Merck Sharp and Dohme [MSD], Oss, the Netherlands) injection to reverse muscle relaxation. Sugammadex dose = 2mg/kg at TOF ≥2 or 4mg/kg at TOF < 2<br>* Other names: Deep Neuromuscular Block;|
| Active Comparator: Moderate Block Group<br>Continuous Rocuronium infusion during surgery Maintain TOF 1 2 At the end of surgery, IV Sugammadex injection to reverse muscle relaxation. (Sugammadex dose = 2mg/kg at TOF ≥2 or 4mg/kg at TOF < 2) | Drug: Control Group<br>* Continuous Rocuronium (Rocnium®, Hanlim Pharm. Co., Ltd., South Korea) infusion during surgery Titrate Rocuronium (Rocnium®) infusion rate to maintain TOF = 1 2 TOF and PTC are assessed by acceleromyograph (TOF-Watch® SX, Organon Ltd., Drynam Road, Swords, Co. Dublin, Ireland). At the end of surgery, IV Sugammadex (Bridion®, Merck Sharp and Dohme [MSD], Oss, the Netherlands) injection to reverse muscle relaxation. Sugammadex dose = 2mg/kg at TOF ≥2 or 4mg/kg at TOF < 2<br>* Other names: Moderate Neuromuscular Block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain: NRS | Postoperative pain on POD 1day and POD 3days assessed by Numeric Rating Scale (NRS) score = 0 10 (No pain = 0, the worst pain = 10) | POD 1day | 
| Postoperative pain: NRS | Postoperative pain on POD 1day and POD 3days assessed by Numeric Rating Scale (NRS) score = 0 10 (No pain = 0, the worst pain = 10) | POD 3days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain: NRS | assessed by Numeric Rating Scale (NRS) score = 0 10 (No pain = 0, the worst pain = 10) | 10 minutes after entering PACU(Post-Anesthetic Care Unit) | 
| Postoperative pain: NRS | assessed by Numeric Rating Scale (NRS) score = 0 10 (No pain = 0, the worst pain = 10) | POD 3months | 
| Postoperative sensory change | Assessed by questionnaire. The questionnaire will ask the patients about the following items. the presence of abnormal sensation -> YES or NO characteristics of abnormal sensation -> 1. Numb 2. Tingling 3. Burning 4. Electricity 5. Other degree of abnormal sensation-> Scoring: 0 7 (No abnormal sensation = 0 . Very severe = 7) | POD 1day | 
| Postoperative sensory change | Assessed by pinprick test. The investigators will check the presence of postoperative sensory change through the pinprick test.-> Site: (1) Chest (2) Neck | POD 1day | 
| Postoperative sensory change | Assessed by questionnaire. The questionnaire will ask the patients about the following items. the presence of abnormal sensation -> YES or NO characteristics of abnormal sensation -> 1. Numb 2. Tingling 3. Burning 4. Electricity 5. Other degree of abnormal sensation-> Scoring: 0 7 (No abnormal sensation = 0 . Very severe = 7) | POD 3days | 
| Postoperative sensory change | Assessed by pinprick test. The investigators will check the presence of postoperative sensory change through the pinprick test.-> Site: (1) Chest (2) Neck | POD 3days | 
| Postoperative sensory change | Assessed by questionnaire. The questionnaire will ask the patients about the following items. the presence of abnormal sensation -> YES or NO characteristics of abnormal sensation -> 1. Numb 2. Tingling 3. Burning 4. Electricity 5. Other degree of abnormal sensation-> Scoring: 0 7 (No abnormal sensation = 0 . Very severe = 7) | POD 3months | 
| Postoperative sensory change | Assessed by pinprick test. The investigators will check the presence of postoperative sensory change through the pinprick test.-> Site: (1) Chest (2) Neck | POD 3months | 
| Nausea/Vomiting | Assessed by nausea/vomiting score Score = 0 3 0: no nausea 1: mild nausea (no medication) 2: severe nausea (anti-emetic used) 3: retching and/or vomiting | 10 minutes after entering PACU(Post-Anesthetic Care Unit) | 
| Nausea/Vomiting | Assessed by nausea/vomiting score Score = 0 3 0: no nausea 1: mild nausea (no medication) 2: severe nausea (anti-emetic used) 3: retching and/or vomiting | POD 1day | 
| Nausea/Vomiting | Assessed by nausea/vomiting score Score = 0 3 0: no nausea 1: mild nausea (no medication) 2: severe nausea (anti-emetic used) 3: retching and/or vomiting | POD 3days | 
| The time from sugammadex injection to TOF ratio 0.9. |  | immediate postoperative | 
| Number of patients with complications due to deep neuromuscular blockade (e.g. Respiratory failure, Desaturation) |  | From surgery to POD 3months |