The Effect of Two Different Local Anesthetic Techniques on Hemodynamic Response and Postoperative Sore Throat in Patients Intubated with Double-Lumen Tubes: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative Sore Throat (POST)
研究概览
简要总结
This clinical trial aims to determine if different local anesthetic application techniques can reduce postoperative sore throat (POST) and manage hemodynamic responses in adult patients undergoing elective thoracic surgery with double-lumen intubation. The main questions it aims to answer are:
- Does inhaled lidocaine or lidocaine applied to the double-lumen tube reduce the incidence and severity of POST?
- How do these anesthetic techniques impact hemodynamic stability during surgery?
Researchers will compare three groups-those receiving inhaled lidocaine, lidocaine applied to the tube, and a saline control group-to see if these methods differ in effectiveness.
Participants will:
- Undergo standard preoperative assessment and provide informed consent
- Be randomly assigned to receive either inhaled lidocaine, lidocaine applied to the tube, or saline
- Have sore throat scores and hemodynamic data recorded at specific intervals after surgery
详细描述
This clinical trial is designed to evaluate the effects of two local anesthetic techniques on postoperative sore throat (POST) incidence and hemodynamic responses in patients undergoing elective thoracic surgery with double-lumen tube (DLT) intubation. POST is a common and undesirable outcome following general anesthesia with endotracheal intubation, particularly with DLTs due to their size and dual cuffs, which can increase mucosal irritation. Addressing POST effectively could significantly improve patient comfort, satisfaction, and overall quality of postoperative care.
**Study Protocol Overview:**
Patients meeting eligibility criteria (aged over 18, ASA I-III) will be recruited from Health Sciences University Kartal City Hospital and randomly assigned to one of three groups:
- Group T (Inhaled Lidocaine): Participants will receive 2 ml of 10% lidocaine inhaled via a Tracheo-Spray device before anesthesia induction. This method is expected to coat the mucosal surfaces of the airway, potentially reducing friction and inflammation.
- Group X (Lidocaine Applied to Tube): Participants will have 10% lidocaine sprayed directly on the distal surface and cuffs of the DLT. This technique aims to provide direct anesthetic coverage on the tube surface, potentially reducing mucosal damage from intubation.
- Group C (Control): Participants will receive 1 ml of 0.9% saline spray as a placebo.
Data Collection:
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)
盲法说明
Statisticians:
The statisticians analyzing the data will remain blinded to the group assignments during the initial stages of analysis to avoid any bias in the interpretation of the results. Unblinding will occur only after the data is fully collected and the analysis plan is in place.
Data Collection Staff:
The staff collecting data in the operating room, recovery room, and patient wards (e.g., monitoring vital signs and postoperative complications) will be blinded to the specific treatment group of the patient. This minimizes any potential bias during the collection of clinical data.
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
- •Aged over 18 years
- •ASA (American Society of Anesthesiologists) scores of 1-3
- •Elective thoracic surgery patients
排除标准
- •Patients with ASA scores of 4 or above
- •Do not consent to participate
- •individuals with mental disorders
- •patients under 18 years of age
- •surgeries exceeding two hours
- •those with known allergies to local anesthetic
研究组 & 干预措施
Group T (Inhaled Lidocaine)
Participants will receive 2 ml of 10% lidocaine via a Tracheo-Spray device before anesthesia induction.
干预措施: Tracheo-Spray (Drug)
Group X (Lidocaine Applied to the Double-Lumen Tube):
Participants will receive 10% lidocaine sprayed directly onto the distal surface and cuffs of the double-lumen tube.
干预措施: Lidocaine Spray on DLT (Drug)
Group C (Control)
Participants will receive 1 ml of 0.9% saline as a placebo.
干预措施: Saline (Placebo) (Drug)
结局指标
主要结局
Postoperative Sore Throat (POST)
时间窗: 2, 6, 12, and 24 hours after surgery
The severity of POST will be assessed at 2, 6, 12, and 24 hours after surgery using a throat pain score, ranging from 0 (no pain) to 5 (worst imaginable pain).
次要结局
- Intraperative Hemodynamic Responses(Basal measurements and 5 minutes after intubation.)
研究者
Murat Tümer, MD
Anesthesiologist
V.K.V. American Hospital, Istanbul