Optimal Concentration of Remifentanil for NIM Tube Intubation With Low-dose NMBA

Thyroidectomy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06162390
• Other study ID #: KNUCH 2023-10-033
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: March 20, 2024

Study information

• Verified date: November 2023
• Source: Kyungpook National University Chilgok Hospital
• Contact: Sung-Hye Byun, M.D.
• Phone: +82-53-200-3869
• Email: stone0311[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: March 20, 2024
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thyroidectomy

Intervention

Drug:
• Remifentanil
Following a sequential allocation scheme, the predetermined Ce of remifentanil for each patient will be determined by the Dixon up-and-down method. The Ce of remifentanil for the first patient will be 4.0 ng/ml, and then the remifentanil Ce will be increased or decreased in 0.5 ng/ml increments for subsequent patients depending on the success or failure of intubation. The Ce of remifentanil to provide acceptable intubation at low dose neuromuscular blockade, the primary outcome, will be determined by obtaining seven crossovers of patients with "acceptable intubation"/"unacceptable intubation" and then calculating the mean of the midpoint doses for each independent pair of patients. According to previous studies that estimated EC50 by Dixon's up-and-down method, 6-8 "failure/success crossover pairs" are required, so this study aims to collect independent data of 7 pairs of "intubation acceptable/unacceptable" patients.

Locations

Country	Name	City	State
Korea, Republic of	Sung Hye Byun	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University Chilgok Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal effect-site concentration (Ce) of remifentanil	Finding the Ce of remifentanil that provides acceptable condition of tracheal intubation when administering a low-dose NMBA is the aim of the study. The Ce of remifentanil for the first patient is 4.0 ng/ml, and then the Ce is increased or decreased in 0.5 ng/ml increments for subsequent patients depending on the success or failure of intubation. About 3 minutes after administering rocuronium 0.3 mg/kg, NIM tube will be intubated. At this time, the intubation condition will be evaluated using the grading system described by Fuchs-Buder. There are 4 items (jaw relaxation, vocal cord position, cough response, and limb movement) that are evaluated, and a total score can be calculated based on them: 1 point if all items are E, 3 points if even one item is P, and 2 points for the rest. A tracheal intubation condition rating of 1 or 2 indicates that the intubation is acceptable (successful), and a rating of 3 indicates that the intubation is unacceptable (unsuccessful).	During the tracheal intubation
Secondary	The rating of each item of the grading system of the tracheal intubation condition	There are 4 items (jaw relaxation, vocal cord position, cough response, and limb movement) in the grading system described by Fuchs-Buder. We will also evaluate the grade of these items.	During the tracheal intubation
Secondary	Total dose of remifentanil administered until tracheal intubation		From the start of the anesthesia induction to tracheal intubation
Secondary	Incidence of hypotension and bradycardia		From the start of the anesthesia induction to tracheal intubation
Secondary	Doses of agents (ephedrine and atropine) administered to treat hypotension and bradycardia		From the start of the anesthesia induction to tracheal intubation