NCT03871387

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

Completed NA Last updated 16 June 2020

What this trial tests

NA trial testing Deep Group in Thyroid Neoplasms in 88 participants. Completed in 24 February 2020.

Timeline

4 March 2019

Primary endpoint
24 February 2020

24 February 2020

Quick facts

Lead sponsor	Yonsei University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	88
Start date	4 March 2019
Primary completion	24 February 2020
Estimated completion	24 February 2020
Sites	1 location across South Korea

Drugs / interventions tested

• Deep Group — full drug profile →
• Control Group — full drug profile →

Conditions studied

• Thyroid Neoplasms — all drugs for Thyroid Neoplasms →

Sponsor

Yonsei University

Who can join

Adults 20 to 70, any sex, with Thyroid Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of Deep Neuromuscular Block during Robot-Assisted Transaxillary Thyroidectomy: A Randomized Controlled Trial.
   Bae MI, Kang SW, Lee JS, Kim NY, et al · · 2023 · cited 1× · PMID 37297828 · DOI 10.3390/jcm12113633