Thyroid NeoplasmsNCT03871387
The Effects of Deep Neuromuscular Blockade During Robot-assisted Transaxillary Thyroidectomy on Postoperative Pain and Sensory Change
A study testing Deep Group in people with Thyroid Neoplasms, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Thyroid Neoplasms
- What is being tested?
- Deep Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Mar 2019to 24 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 120-752
About this study
Official title: The Effects of Deep Neuromuscular Blockade During Robot-assisted Transaxillary Thyroidectomy on Postoperative Pain and Sensory Change; Prospective Randomized Control Trial
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.
Read more
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
- Being tested
- Deep Group, Control Group
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep GroupDrug
Also called Deep Neuromuscular Block
- 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
Control GroupDrug
Also called Moderate Neuromuscular Block
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: POD 3days
Secondary outcomes (13)
Postoperative pain: NRS
- assessed by Numeric Rating Scale (NRS)
- score = 0~10 (No pain = 0, the worst pain = 10)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: POD 3days
The time from sugammadex injection to TOF ratio 0.9.
Measured: immediate postoperative
Number of patients with complications due to deep neuromuscular blockade (e.g. Respiratory failure, Desaturation)
Measured: From surgery to POD 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start4 Mar 2019
- Primary completion24 Feb 2020
- Study completion24 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871387
- Sponsor's protocol ID
- 4-2018-0963
- Status last verified
- Jun 2020
- First submitted
- 26 Feb 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23528724Lee 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.
PubMed 20490558Tae 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.
PubMed 21688343Kang 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.
PubMed 19632588Kim 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.
PubMed 26945393Martini 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.
PubMed 24240315Dubois 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.
PubMed 24809482Jones 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.
PubMed 18946293Geldner 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.
PubMed 22698066Welliver 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.
PubMed 19920893
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Deep Neuromuscular Blockade During Robot-assisted Transaxillary Thyroidectomy on Postoperative Pain and Sensory Change; Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03871387
- Acronym / sponsor ID
- 4-2018-0963
- Conditions
- Thyroid Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Deep Block Group | Experimental | Drug: Deep 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) |
| Moderate Block Group | Active comparator | Drug: Control 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) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep GroupAlso: Deep Neuromuscular Block* 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 | Drug | Deep Block Group |
| Control GroupAlso: Moderate Neuromuscular Block* 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 | Drug | Moderate Block Group |
Primary outcome
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)
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)
13 secondary outcomes
Postoperative pain: NRS
Time frame: 10 minutes after entering PACU(Post-Anesthetic Care Unit)
Postoperative pain: NRS
Time frame: POD 3months
Postoperative sensory change
Time frame: POD 1day
Postoperative sensory change
Time frame: POD 1day
Postoperative sensory change
Time frame: POD 3days
Postoperative sensory change
Time frame: POD 3days
Postoperative sensory change
Time frame: POD 3months
Postoperative sensory change
Time frame: POD 3months
Nausea/Vomiting
Time frame: 10 minutes after entering PACU(Post-Anesthetic Care Unit)
Nausea/Vomiting
Time frame: POD 1day
Nausea/Vomiting
Time frame: POD 3days
The time from sugammadex injection to TOF ratio 0.9.
Time frame: immediate postoperative
Number of patients with complications due to deep neuromuscular blockade (e.g. Respiratory failure, Desaturation)
Time frame: From surgery to POD 3months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 23528724Lee 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.
- Background: PubMed 20490558Lee 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.
- Background: PubMed 21688343Tae 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.
- Background: PubMed 19632588Kang 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.
- Background: PubMed 26945393Kim 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.
- Background: PubMed 24240315Martini 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.
- Background: PubMed 24809482Dubois 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.
- Background: PubMed 18946293Jones 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.
- Background: PubMed 22698066Geldner 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.
- Background: PubMed 19920893Welliver 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Group in people with Thyroid Neoplasms, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain: NRS (time frame: POD 1day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03871387, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.