Clinical trial NCT06162390: Optimal Concentration of Remifentanil for NIM Tube Intubation With Low-dose NMBA
Official title: Optimal Concentration of Remifentanil for Achieving Excellent Intubating Condition During Low-dose Neuromuscular Blocking Agent Administration for Intraoperative Neuromonitoring Using Nerve Integrity Monitoring Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroidectomy
Keywords: Intraoperative nerve monitoring
Neuromuscular blocking agents
Remifentanil
Lead sponsor: Kyungpook National University Chilgok Hospital
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 21
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: During thyroid surgery, Intraoperative Neuromonitoring (IONM) plays a crucial role in preventing serious complications such as bilateral vocal cord paralysis. It achieves this by detecting damage to the recurrent laryngeal nerve (RLN) and predicting the RLN's functional status. The utilization of Nerve Integrity Monitoring tubes (NIM tubes) is on the rise for effective IONM. As IONM relies on observing electromyographic (EMG) responses to direct electrical nerve stimulation, the routine use of neuromuscular blocking agents (NMBAs) in general anesthesia can impact the interpretation of IONM results and potentially reduce sensitivity to nerve responses to stimulation. However, the use of NMBAs is essential for ensuring smooth endotracheal intubation in patients undergoing general anesthesia. Numerous studies suggest that NMBA usage provides superior intubation conditions and reduces vocal cord complications compared to scenarios without NMBA.

Various regimens for neuromuscular blockade methods are employed during IONM in thyroid surgery, ranging from not using NMBAs at all to using a full dose of NMBA for intubation. This is followed by the administration of sugammadex, an NMBA reversal agent, before nerve monitoring. One of the methods known for providing satisfactory intubation conditions while ensuring the quality of EMG signals during IONM in thyroid surgery is using rocuronium at an ED95 dose of 0.3 mg/kg. This approach is considered suitable for most IONM scenarios. However, when adequate muscle relaxation is not achieved, not all patients can undergo intubation, necessitating a strategy for appropriate intubation conditions.

Historically, it has been reported that achieving satisfactory intubation conditions without the use of NMBA during general anesthesia requires higher amounts of propofol and opioids. Therefore, the assumption is made that using remifentanil, an opioid used in total intravenous anesthesia (TIVA), at an appropriate concentration can provide acceptable intubation conditions with minimal NMBA use for patients undergoing IONM.

This study aims to determine the optimal concentration of remifentanil needed to achieve excellent intubation conditions in patients undergoing thyroid surgery with IONM using rocuronium 0.3 mg/kg as the NMBA during TIVA


Eligibility criteria: Inclusion Criteria:

* All female aged 20-60
* ASA (American Society of Anesthesiologists) physical status I or II
* who scheduled for thyroidectomy under intraoperative neuromonitoring with a nerve integrity monitoring tube (NIM tube)

Exclusion Criteria:

* Patients anticipated to experience challenging intubation.
* Patients who have had an upper respiratory tract infection within the past 2 weeks.
* Patients with a history of heart, lung, and kidney diseases.
* Patients with a body mass index (BMI) of 30 kg/m² or higher.
* Patients currently taking analgesics.
* Patients expressing a desire not to participate in the study.

Primary outcomes:
measure: Optimal effect-site concentration (Ce) of remifentanil
timeFrame: During the tracheal intubation
Secondary outcomes:
measure: The rating of each item of the grading system of the tracheal intubation condition
timeFrame: During the tracheal intubation
measure: Total dose of remifentanil administered until tracheal intubation
timeFrame: From the start of the anesthesia induction to tracheal intubation
measure: Incidence of hypotension and bradycardia
timeFrame: From the start of the anesthesia induction to tracheal intubation
measure: Doses of agents (ephedrine and atropine) administered to treat hypotension and bradycardia
timeFrame: From the start of the anesthesia induction to tracheal intubation
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Sung Hye Byun
Study officials:
References:
citation: Zheng S, Xu Z, Wei Y, Zeng M, He J. Effect of intraoperative neuromonitoring on recurrent laryngeal nerve palsy rates after thyroid surgery--a meta-analysis. J Formos Med Assoc. 2013 Aug;112(8):463-72. doi: 10.1016/j.jfma.2012.03.003. Epub 2012 Sep 7.
citation: Marusch F, Hussock J, Haring G, Hachenberg T, Gastinger I. Influence of muscle relaxation on neuromonitoring of the recurrent laryngeal nerve during thyroid surgery. Br J Anaesth. 2005 May;94(5):596-600. doi: 10.1093/bja/aei110. Epub 2005 Feb 25.
citation: Combes X, Andriamifidy L, Dufresne E, Suen P, Sauvat S, Scherrer E, Feiss P, Marty J, Duvaldestin P. Comparison of two induction regimens using or not using muscle relaxant: impact on postoperative upper airway discomfort. Br J Anaesth. 2007 Aug;99(2):276-81. doi: 10.1093/bja/aem147. Epub 2007 Jun 15.
citation: Lu IC, Wu SH, Wu CW. Neuromuscular blockade management for intraoperative neural monitoring. Kaohsiung J Med Sci. 2020 Apr;36(4):230-235. doi: 10.1002/kjm2.12153. Epub 2019 Nov 12.
citation: Grant S, Noble S, Woods A, Murdoch J, Davidson A. Assessment of intubating conditions in adults after induction with propofol and varying doses of remifentanil. Br J Anaesth. 1998 Oct;81(4):540-3. doi: 10.1093/bja/81.4.540.