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

Not Applicable

Recruiting

• Conditions: Thyroidectomy
• Interventions: Drug: Remifentanil

• Registration Number: NCT06162390
• Lead Sponsor: Kyungpook National University Chilgok Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-20
• Study First Submitted: 2023-11-20
• Study First Submitted QC: 2023-11-29
• Last Update Submitted: 2023-11-29
• Study First Posted: 2023-12-08
• Last Update Posted: 2023-12-08
• Primary Completion: 2024-03-20
• Study Completion: 2024-03-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 23

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Remifentanil for NIM tube intubation	Remifentanil	-

Primary Outcome Measures

Name	Time	Method
Optimal effect-site concentration (Ce) of remifentanil	During the tracheal intubation	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).

Secondary Outcome Measures

Name	Time	Method
The rating of each item of the grading system of the tracheal intubation condition	During the tracheal intubation	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.
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

Trial Locations

Locations (1)

Sung Hye Byun; 🇰🇷 Daegu, Korea, Republic of