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

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ClinicalTrials.gov Identifier: NCT03871387
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Thyroid Neoplasms Drug: Deep Group Drug: Control Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. Deep group

    • Continuous rocuronium infusion during surgery
    • Maintain TOF = 0 & PTC= 1~2 (Deep neuromuscular block)
  2. Control group

    • Continuous rocuronium infusion during surgery
    • Maintain TOF 1~2 (Moderate neuromuscular block)
Masking: Double (Participant, Care Provider)
Masking Description: Participants and Care Providers will be blinded.
Primary Purpose: Prevention
Official Title: The Effects of Deep Neuromuscular Blockade During Robot-assisted Transaxillary Thyroidectomy on Postoperative Pain and Sensory Change; Prospective Randomized Control Trial
Actual Study Start Date : March 4, 2019
Actual Primary Completion Date : February 24, 2020
Actual Study Completion Date : February 24, 2020

Arm Intervention/treatment
Experimental: Deep Block Group
  • 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
  • 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
Other Name: Deep Neuromuscular Block

Active Comparator: Moderate Block Group
  • 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
  • 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
Other Name: Moderate Neuromuscular Block




Primary Outcome Measures :
  1. Postoperative pain: NRS [ Time Frame: POD 1day ]

    Postoperative pain on POD 1day and POD 3days

    • assessed by Numeric Rating Scale (NRS)
    • score = 0~10 (No pain = 0, the worst pain = 10)

  2. Postoperative pain: NRS [ Time Frame: POD 3days ]

    Postoperative pain on POD 1day and POD 3days

    • assessed by Numeric Rating Scale (NRS)
    • score = 0~10 (No pain = 0, the worst pain = 10)


Secondary Outcome Measures :
  1. Postoperative pain: NRS [ Time Frame: 10 minutes after entering PACU(Post-Anesthetic Care Unit) ]
    • assessed by Numeric Rating Scale (NRS)
    • score = 0~10 (No pain = 0, the worst pain = 10)

  2. Postoperative pain: NRS [ Time Frame: POD 3months ]
    • assessed by Numeric Rating Scale (NRS)
    • score = 0~10 (No pain = 0, the worst pain = 10)

  3. Postoperative sensory change [ Time Frame: POD 1day ]

    Assessed by questionnaire. The questionnaire will ask the patients about the following items.

    1. the presence of abnormal sensation -> YES or NO
    2. characteristics of abnormal sensation -> 1. Numb 2. Tingling 3. Burning 4. Electricity 5. Other
    3. degree of abnormal sensation-> Scoring: 0~7 (No abnormal sensation = 0 . Very severe = 7)

  4. Postoperative sensory change [ Time Frame: POD 1day ]
    Assessed by pinprick test. The investigators will check the presence of postoperative sensory change through the pinprick test.-> Site: (1) Chest (2) Neck

  5. Postoperative sensory change [ Time Frame: POD 3days ]

    Assessed by questionnaire. The questionnaire will ask the patients about the following items.

    1. the presence of abnormal sensation -> YES or NO
    2. characteristics of abnormal sensation -> 1. Numb 2. Tingling 3. Burning 4. Electricity 5. Other
    3. degree of abnormal sensation-> Scoring: 0~7 (No abnormal sensation = 0 . Very severe = 7)

  6. Postoperative sensory change [ Time Frame: POD 3days ]
    Assessed by pinprick test. The investigators will check the presence of postoperative sensory change through the pinprick test.-> Site: (1) Chest (2) Neck

  7. Postoperative sensory change [ Time Frame: POD 3months ]

    Assessed by questionnaire. The questionnaire will ask the patients about the following items.

    1. the presence of abnormal sensation -> YES or NO
    2. characteristics of abnormal sensation -> 1. Numb 2. Tingling 3. Burning 4. Electricity 5. Other
    3. degree of abnormal sensation-> Scoring: 0~7 (No abnormal sensation = 0 . Very severe = 7)

  8. Postoperative sensory change [ Time Frame: POD 3months ]
    Assessed by pinprick test. The investigators will check the presence of postoperative sensory change through the pinprick test.-> Site: (1) Chest (2) Neck

  9. Nausea/Vomiting [ Time Frame: 10 minutes after entering PACU(Post-Anesthetic Care Unit) ]
    • 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. Nausea/Vomiting [ Time Frame: POD 1day ]
    • 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

  11. Nausea/Vomiting [ Time Frame: POD 3days ]
    • 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

  12. The time from sugammadex injection to TOF ratio 0.9. [ Time Frame: immediate postoperative ]
  13. Number of patients with complications due to deep neuromuscular blockade (e.g. Respiratory failure, Desaturation) [ Time Frame: From surgery to POD 3months ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871387


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Publications:

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03871387    
Other Study ID Numbers: 4-2018-0963
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thyroid Neoplasms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases