Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162390
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-11-20
Brief Title:
Optimal Concentration of Remifentanil for NIM Tube Intubation With Low-dose NMBA
Sponsor:
Kyungpook National University Chilgok Hospital
Organization:
Kyungpook National University Chilgok Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 RLNs 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 03 mgkg 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 03 mgkg as the NMBA during TIVA
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 03 mgkg 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 03 mgkg as the NMBA during TIVA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None