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

NCT06162390 | Completed

• 1 other identifier: KNUCH 2023-10-033
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Thyroidectomy

Keywords

Intraoperative nerve monitoring; Neuromuscular blocking agents; Remifentanil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The rating of each item of the grading system of the tracheal intubation condition

  During the tracheal intubation

• Total dose of remifentanil administered until tracheal intubation

  From the start of the anesthesia induction to tracheal intubation

• Incidence of hypotension and bradycardia

  From the start of the anesthesia induction to tracheal intubation

• Doses of agents (ephedrine and atropine) administered to treat hypotension and bradycardia

  From the start of the anesthesia induction to tracheal intubation

Study Arms (1)

Remifentanil for NIM tube intubation

EXPERIMENTAL

Drug: Remifentanil

Interventions

Remifentanil DRUG

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.

Remifentanil for NIM tube intubation

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyungpook National University Chilgok Hospital: lead

Study Sites (1)

Sung Hye Byun

Daegu, Daegu, 41404, South Korea

Location

Related Publications (5)

• 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.

  PMID: 24016611 BACKGROUND

• 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.

  PMID: 15734779 BACKGROUND

• 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.

  PMID: 17573390 BACKGROUND

• 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.

  PMID: 31713975 BACKGROUND

• 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.

  PMID: 9924229 BACKGROUND

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is one arm non-randomized approach. Since it is a sequential approach of medication administration, the anesthesiologist and patients were blinded to whatever dose was given.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 8, 2023
• Study Start: November 20, 2023
• Primary Completion: March 10, 2024
• Study Completion: March 20, 2024
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)