Effect of Hydrocortisone and Lidocaine on Endotracheal Tube for Sore Throat and Hoarseness After Thyroid/Parathyroid Surgery With Neuromonitoring: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 764
- 试验地点
- 2
- 主要终点
- Frequency of severe throat pain at 24 hours post-operation
研究概览
简要总结
This randomized clinical trial aims to evaluate the effectiveness of two medications-hydrocortisone ointment and lidocaine solution-applied to the endotracheal tube in reducing postoperative throat pain, hoarseness, and cough following thyroid or parathyroid surgery with neuromonitoring.
A total of 764 adult patients undergoing elective neck surgery at Saint-Petersburg State University Hospital will be enrolled and randomly assigned to receive either a hydrocortisone-coated or lidocaine-coated endotracheal tube.
Outcomes will be assessed upon awakening from anesthesia, at 24 hours, and again at 3 days postoperatively.
The findings may contribute to improving postoperative comfort and recovery for patients undergoing similar surgical procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective open surgery on the thyroid/parathyroid glands with intraoperative neuromonitoring.
- •Age ≥18 years.
- •Willing and able to provide voluntary informed consent for participation in the study.
排除标准
- •Pregnancy (for women of childbearing potential).
- •Known allergy to hydrocortisone or lidocaine.
- •Refusal to participate in the study.
研究组 & 干预措施
Hydrocortisone group
Participants receive endotracheal tubes coated with 1% hydrocortisone ointment to reduce postoperative sore throat and hoarseness.
干预措施: Hydrocortisone Acetate 1% Ointment (Drug)
Lidocaine group
Participants receive endotracheal tubes coated with 0.05% lidocaine and chlorhexidine solution (Cathelgel).
干预措施: Lidocaine hydrochloride 0,05% with chlorhexidine (Drug)
结局指标
主要结局
Frequency of severe throat pain at 24 hours post-operation
时间窗: 24 hours post-operation
Proportion of patients scoring ≥3 points on the STONES throat pain subscale (0 = no pain, 1 = mild, 2 = moderate, 3 = severe pain) assessed 24 hours after thyroid/parathyroid surgery. Evaluated through patient-reported questionnaire administered by a blinded investigator.
Frequency of clinically significant EMG signal reduction
时间窗: Perioperative/periprocedural
Proportion of patients showing ≥50% decrease in amplitude of electromyographic (EMG) signals from recurrent laryngeal nerve during intraoperative neuromonitoring compared to baseline measurements (V1/ R1 timepoints), using the C2 neuromonitor system.
次要结局
- Episodes of complete EMG signal loss during surgery(Perioperative/periprocedural)
- Vocal cord mobility impairment (laryngoscopy)(72 hours after surgery)
- Neck Disability Index (NDI) score(3 days after surgery)
- Frequency of intraoperative laryngeal reflexes (coughing)(Perioperative/periprocedural)
研究者
Efremov Sergey
Deputy director for science, Saint-Petersburg state university hospital
Saint Petersburg State University, Russia