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NCT Number: NCT03871387

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

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.

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Key information

Conditions

Thyroid Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep Group

Drug
  • 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 names: Deep Neuromuscular Block

Control group

Drug
  • 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 names: Moderate Neuromuscular Block

Primary outcomes

  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 outcomes

  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.

    • 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)

  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.

    • 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)

  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.

    • 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)

  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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2019
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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