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

NCT03871387 | Completed

• 1 other identifier: 4-2018-0963
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Postoperative pain: NRS

  10 minutes after entering PACU(Post-Anesthetic Care Unit)

• Postoperative pain: NRS

  POD 3months

• Postoperative sensory change

  POD 1day

• Postoperative sensory change

  POD 1day

• Postoperative sensory change

  POD 3days

Study Arms (2)

Deep Block Group

EXPERIMENTAL

* 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

Moderate Block Group

ACTIVE COMPARATOR

* 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

Interventions

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

Also known as: Deep Neuromuscular Block

Deep Block Group

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

Also known as: Moderate Neuromuscular Block

Moderate Block Group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 120-752, South Korea

Location

Related Publications (10)

• Lee J, Chung WY. Robotic thyroidectomy and neck dissection: past, present, and future. Cancer J. 2013 Mar-Apr;19(2):151-61. doi: 10.1097/PPO.0b013e31828aab61.

  PMID: 23528724 BACKGROUND

• Lee J, Nah KY, Kim RM, Ahn YH, Soh EY, Chung WY. Differences in postoperative outcomes, function, and cosmesis: open versus robotic thyroidectomy. Surg Endosc. 2010 Dec;24(12):3186-94. doi: 10.1007/s00464-010-1113-z. Epub 2010 May 19.

  PMID: 20490558 BACKGROUND

• Tae K, Ji YB, Cho SH, Lee SH, Kim DS, Kim TW. Early surgical outcomes of robotic thyroidectomy by a gasless unilateral axillo-breast or axillary approach for papillary thyroid carcinoma: 2 years' experience. Head Neck. 2012 May;34(5):617-25. doi: 10.1002/hed.21782. Epub 2011 Jun 17.

  PMID: 21688343 BACKGROUND

• Kang SW, Jeong JJ, Nam KH, Chang HS, Chung WY, Park CS. Robot-assisted endoscopic thyroidectomy for thyroid malignancies using a gasless transaxillary approach. J Am Coll Surg. 2009 Aug;209(2):e1-7. doi: 10.1016/j.jamcollsurg.2009.05.003. Epub 2009 Jun 12. No abstract available.

  PMID: 19632588 BACKGROUND

• Kim MH, Lee KY, Lee KY, Min BS, Yoo YC. Maintaining Optimal Surgical Conditions With Low Insufflation Pressures is Possible With Deep Neuromuscular Blockade During Laparoscopic Colorectal Surgery: A Prospective, Randomized, Double-Blind, Parallel-Group Clinical Trial. Medicine (Baltimore). 2016 Mar;95(9):e2920. doi: 10.1097/MD.0000000000002920.

  PMID: 26945393 BACKGROUND

• Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.

  PMID: 24240315 BACKGROUND

• Dubois PE, Putz L, Jamart J, Marotta ML, Gourdin M, Donnez O. Deep neuromuscular block improves surgical conditions during laparoscopic hysterectomy: a randomised controlled trial. Eur J Anaesthesiol. 2014 Aug;31(8):430-6. doi: 10.1097/EJA.0000000000000094.

  PMID: 24809482 BACKGROUND

• Jones RK, Caldwell JE, Brull SJ, Soto RG. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008 Nov;109(5):816-24. doi: 10.1097/ALN.0b013e31818a3fee.

  PMID: 18946293 BACKGROUND

• Geldner G, Niskanen M, Laurila P, Mizikov V, Hubler M, Beck G, Rietbergen H, Nicolayenko E. A randomised controlled trial comparing sugammadex and neostigmine at different depths of neuromuscular blockade in patients undergoing laparoscopic surgery. Anaesthesia. 2012 Sep;67(9):991-8. doi: 10.1111/j.1365-2044.2012.07197.x. Epub 2012 Jun 14.

  PMID: 22698066 BACKGROUND

• Welliver M, McDonough J, Kalynych N, Redfern R. Discovery, development, and clinical application of sugammadex sodium, a selective relaxant binding agent. Drug Des Devel Ther. 2009 Feb 6;2:49-59. doi: 10.2147/dddt.s2757.

  PMID: 19920893 BACKGROUND

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants and Care Providers will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 12, 2019
• Study Start: March 4, 2019
• Primary Completion: February 24, 2020
• Study Completion: February 24, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)