This single-center prospective randomized interventional study evaluated whether intraoperative low-current stimulation could assist recurrent laryngeal nerve localization and reduce temporary recurrent laryngeal nerve injury during thyroid surgery.
A total of 150 patients undergoing thyroid surgery at the Second Affiliated Hospital of Kunming Medical University were randomly allocated in a 1:1:1 ratio to conventional anatomical identification, 3 mA low-current stimulation, or 5 mA low-current stimulation. All participants underwent preoperative and postoperative electronic laryngoscopy. The primary outcome was temporary recurrent laryngeal nerve injury. Secondary outcomes included permanent recurrent laryngeal nerve injury, operative duration, intraoperative blood loss, postoperative hospital stay, and stimulation-related adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
150
Low-current stimulation at 3 mA was used as an adjunct to anatomical recurrent laryngeal nerve identification. Response was judged according to visible or palpable laryngeal twitch.
Low-current stimulation at 5 mA was used as an adjunct to anatomical recurrent laryngeal nerve identification. Response was judged according to visible or palpable laryngeal twitch.
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Number of Participants With Permanent Recurrent Laryngeal Nerve Injury Confirmed by Electronic Laryngoscopy
Permanent recurrent laryngeal nerve injury is defined as unilateral or bilateral vocal cord paresis or paralysis detected after surgery and still present at the 6-month postoperative assessment, as confirmed by electronic laryngoscopy. The number of participants meeting this definition will be reported.
Time frame: 6 months after surgery
Number of Participants With Vocal Cord Paresis or Paralysis Persisting at 6 Months, as Assessed by Electronic Laryngoscopy
Permanent recurrent laryngeal nerve injury is defined as unilateral or bilateral vocal cord paresis or paralysis detected after surgery and still present at the 6-month postoperative assessment, as confirmed by electronic laryngoscopy. The number of participants meeting this definition will be reported.
Time frame: 6 months after surgery
Total Operative Duration in Minutes
Total operative duration will be measured in minutes from the initial skin incision to completion of skin closure.
Time frame: Intraoperative period
Intraoperative blood loss
Estimated intraoperative blood loss measured in milliliters.
Time frame: Intraoperative period
Duration of Postoperative Hospital Stay in Days
Postoperative hospital stay will be calculated as the number of calendar days from the date of surgery to the date of hospital discharge.
Time frame: From the date of surgery until hospital discharge, assessed up to 30 days after surgery
Number of Participants With Stimulation-Related Adverse Events
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The number of participants experiencing at least one stimulation-related adverse event will be reported. Stimulation-related adverse events include suspected thermal injury, arrhythmia, hemodynamic instability, muscle burn, overstimulation, or suspected false-negative nerve localization, as documented in the intraoperative and postoperative medical records.
Time frame: From initiation of intraoperative nerve stimulation through 30 days after surgery