Clinical trial NCT03871387: The Effects of Deep Neuromuscular Blockade During Robot-assisted Transaxillary Thyroidectomy on Postoperative Pain and Sensory Change
Official title: The Effects of Deep Neuromuscular Blockade During Robot-assisted Transaxillary Thyroidectomy on Postoperative Pain and Sensory Change; Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Neoplasms
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 88
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Postoperative pain: NRS
timeFrame: POD 1day
measure: Postoperative pain: NRS
timeFrame: POD 3days
Secondary outcomes:
measure: Postoperative pain: NRS
timeFrame: 10 minutes after entering PACU(Post-Anesthetic Care Unit)
measure: Postoperative pain: NRS
timeFrame: POD 3months
measure: Postoperative sensory change
timeFrame: POD 1day
measure: Postoperative sensory change
timeFrame: POD 1day
measure: Postoperative sensory change
timeFrame: POD 3days
measure: Postoperative sensory change
timeFrame: POD 3days
measure: Postoperative sensory change
timeFrame: POD 3months
measure: Postoperative sensory change
timeFrame: POD 3months
measure: Nausea/Vomiting
timeFrame: 10 minutes after entering PACU(Post-Anesthetic Care Unit)
measure: Nausea/Vomiting
timeFrame: POD 1day
measure: Nausea/Vomiting
timeFrame: POD 3days
measure: The time from sugammadex injection to TOF ratio 0.9.
timeFrame: immediate postoperative
measure: Number of patients with complications due to deep neuromuscular blockade (e.g. Respiratory failure, Desaturation)
timeFrame: From surgery to POD 3months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.