EFFECT OF DEXMEDETOMİDİNE ON RECURRENT LARYNGEAL NERVE MONİTORİNG: A COMPARATİVE STUDY WİTH MİDAZOLAM

Completed

• Conditions: Thyroid Surgery Intraoperative Nerve Monitoring (IONM) Recurrent Laryngeal Nerve Function Dexmedetomidine vs Midazolam (Anesthetic Agents)

• Registration Number: NCT07195214
• Lead Sponsor: Amasya University

Brief Summary

This prospective observational study evaluated the effect of dexmedetomidine compared with midazolam on intraoperative monitoring of the recurrent laryngeal nerve during thyroid surgery. The main goal was to assess whether dexmedetomidine influences the time to identify the recurrent laryngeal nerve and the quality of nerve signals. Secondary outcomes included time to vagus nerve identification, intraoperative hemodynamic changes, extubation time, postoperative nausea and vomiting, sedation levels, and recovery parameters. A total of 60 adult patients undergoing thyroidectomy with intraoperative neuromonitoring were included. The findings are expected to guide anesthetic choices that optimize patient safety and surgical outcomes in thyroid operations.

Detailed Description

This prospective observational study was conducted to investigate the effect of dexmedetomidine compared with midazolam on intraoperative monitoring of the recurrent laryngeal nerve (RLN) during thyroid surgery. Sixty adult patients scheduled for thyroidectomy under general anesthesia with intraoperative nerve monitoring were enrolled. Patients were allocated to receive either dexmedetomidine or midazolam as part of anesthesia induction. The primary objective was to compare the time required to identify the recurrent laryngeal nerve and the quality of electromyographic signals between the two groups. Secondary outcomes included time to vagus nerve identification, intraoperative hemodynamic changes such as bradycardia or hypotension, amplitude and latency of RLN signals, extubation time, postoperative nausea and vomiting, sedation scores, and length of stay in the post-anesthesia care unit. The study was approved by the Amasya University Non-Interventional Clinical Research Ethics Committee (Approval No: E-30640013-050.04-246788). Findings from this study may contribute to optimizing anesthetic protocols for thyroid surgery to improve patient safety and surgical outcomes.

Study Timeline

• Study Start: 2025-02-24
• Primary Completion: 2025-05-28
• Study Completion: 2025-07-30
• Status Verified: 2025-09
• Study First Submitted: 2025-09-18
• Study First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Adults aged 18-65 years Patients scheduled for elective thyroidectomy under general anesthesia American Society of Anesthesiologists (ASA) physical status I-II Planned use of intraoperative nerve monitoring (IONM) Provided written informed consent

Exclusion Criteria

Previous neck surgery or radiotherapy affecting recurrent laryngeal nerve anatomy Pre-existing vocal cord paralysis or laryngeal nerve dysfunction Severe cardiovascular disease (e.g., advanced heart block, uncontrolled hypertension) Severe hepatic or renal dysfunction Known allergy or contraindication to dexmedetomidine, midazolam, or study medications Pregnancy or breastfeeding Refusal to participate or inability to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Identification of the Recurrent Laryngeal Nerve (minutes)	Intraoperative period (from skin incision until RLN identification, typically within the first 60 minutes of surgery).	The interval between the start of intraoperative neuromonitoring and the successful identification of the recurrent laryngeal nerve during thyroidectomy. This measure evaluates whether dexmedetomidine or midazolam affects the speed of RLN identification.

Trial Locations

Locations (1)

Amasya Univessity; Amasya, Turkey (Türkiye)