Comparison of Dexmedetomidine and Superior Laryngeal Nerve Block for Non-Intubated Endoscopic Laryngeal Surgery With Spontaneous Breathing Using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Perioperative PaCO2
研究概览
简要总结
This prospective, randomized controlled trial evaluated the efficacy and safety of two anesthetic strategies-dexmedetomidine infusion and ultrasound-guided superior laryngeal nerve block (SLNB)-in patients undergoing non-intubated endoscopic laryngeal surgery under spontaneous breathing supported by Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE). The primary outcome was the arterial partial pressure of carbon dioxide (PaCO₂), measured at three time points: before oxygenation, at the end of surgery, and in the post-anesthesia care unit (PACU). Secondary outcomes included other arterial blood gas parameters, hemodynamic variables, and surgeon satisfaction scores.
详细描述
Detailed Description:
This prospective, single-center randomized controlled trial was conducted to compare two anesthetic strategies-Dexmedetomidine infusion and ultrasound-guided bilateral superior laryngeal nerve block (SLNB)-for non-intubated endoscopic laryngeal surgery performed under spontaneous respiration with high-flow nasal oxygenation (THRIVE). The study was carried out at Kaohsiung Veterans General Hospital, Taiwan.
Patients aged 20 to 80 years scheduled for elective microlaryngeal surgery were enrolled and randomly assigned to either the Dexmedetomidine (Dex) group or the SLNB group. Both groups received total intravenous anesthesia (TIVA) with propofol and oxygenation via transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) to facilitate tubeless anesthesia. The Dex group received a loading dose of Dexmedetomidine (1 µg/kg over 10 minutes) followed by continuous infusion (1 µg/kg/h), while the SLNB group underwent bilateral ultrasound-guided nerve blocks with 1% lidocaine.
The primary outcome was the arterial partial pressure of carbon dioxide (PaCO₂) measured at three time points: before oxygenation (baseline), at the end of surgery, and 15 minutes after arrival in the post-anesthesia care unit (PACU). Secondary outcomes included arterial blood gas parameters (PaO₂, pH), intraoperative hemodynamic variables (HR, SBP, DBP, MAP), and surgeon satisfaction scores.
The goal of this study was to evaluate whether Dexmedetomidine, which offers both sedative and analgesic properties while preserving spontaneous breathing, could serve as a viable alternative to regional nerve block in the context of shared-airway surgery. Particular attention was given to the risk of carbon dioxide accumulation and respiratory acidosis associated with Dexmedetomidine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are between 20-80 years old.
- •Patients undergoing endoscopic laryngeal surgery.
- •Anesthesiologists rated ASA as between I and III.
排除标准
- •Having drug dependence and drinking habits.
- •Abnormal heart, liver and kidney function.
- •Allergic reactions to narcotic drugs.
- •Emergency surgery.
- •pregnancy.
- •Refuse to participate.
- •BMI ≥ 35 kg/m2.
研究组 & 干预措施
Dexmedetomidine Infusion Arm for Non-Intubated Laryngeal Surgery Using THRIVE
This arm involves patients undergoing endoscopic laryngeal surgery under non-intubated general anesthesia with spontaneous breathing, supported by transnasal humidified rapid-insufflation ventilatory exchange (THRIVE). Patients receive an intravenous loading dose of dexmedetomidine (1 µg/kg over 10 minutes), followed by a continuous infusion (1 µg/kg/h) for sedation and analgesia. No regional nerve blocks are performed in this arm. Supplemental propofol is titrated via target-controlled infusion (TCI) to maintain BIS levels between 40-60. Topical 10% lidocaine is applied to the airway before insertion of the laryngoscope. Intraoperative fentanyl may be given as needed based on hemodynamic responses.
干预措施: Dexmetedomedine infusion (Drug)
Superior Laryngeal Nerve Block (SLNB)
This arm includes patients undergoing non-intubated endoscopic laryngeal surgery with spontaneous breathing, supported by transnasal humidified rapid-insufflation ventilatory exchange (THRIVE). After induction with propofol (via TCI) and standard premedication, bilateral ultrasound-guided superior laryngeal nerve blocks are performed using 5 mL of 1% lidocaine on each side for regional analgesia. No dexmedetomidine is administered in this group. Anesthesia is maintained with propofol titrated to a BIS range of 40-60. Additional fentanyl may be administered intraoperatively as needed to control sympathetic responses. Topical 10% lidocaine is applied to the airway prior to laryngoscope insertion.
干预措施: Ultrasound-Guided Superior Laryngeal Nerve Block (SLNB) (Procedure)
结局指标
主要结局
Perioperative PaCO2
时间窗: From pre-induction through 15 minutes postoperatively
Arterial blood gas was collected and analyzed at three time points to assess changes in PaCO₂ as the primary outcome: 1. At baseline (after preoxygenation, prior to induction) 2. Immediately after completion of endoscopic laryngeal surgery 3. Fifteen minutes after arrival in the post-anesthesia care unit (PACU)
次要结局
- Arterial Oxygenation (PaO₂)(From pre-induction through 15 minutes postoperatively)
- Mean Arterial Pressure (MAP)(Preoperative, intraoperative (every 5 minutes), and 15 minutes postoperatively in the PACU)
- Heart rate(Preoperative, intraoperative (every 5 minutes), and 15 minutes postoperatively in the PACU)
- Surgeon stress score(Immediately after completion of the surgical procedure)
- Arterial pH(Baseline, end of surgery, PACU (15 minutes post-arrival))
研究者
Yuan-Yi Chia
Chief of Anesthesiology
Kaohsiung Veterans General Hospital.