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临床试验/NCT07202624
NCT07202624已完成2 期

Evaluating the Effectiveness of Intracuff Dexmedetomidine Versus Alkalinized Lidocaine in Preventing Postoperative Sore Throat Following Prolonged Prone Surgery

Prince Sultan Military Medical City1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2025年2月10日最近更新:
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
4
试验地点
1
主要终点
the incidence and severity of POST, hoarseness, cough

研究概览

简要总结

Postoperative sore throat (POST) is a common consequence of tracheal intubation, affecting 30% to 65% of patients, while hoarseness occurs in approximately 16% to 55% of cases. POST is undesirable as it negatively impacts the surgical experience, patient satisfaction, and daily activities even after discharge. It can result from factors such as vocal cord damage, nerve compression, blood loss, and injury to mucosal cells due to airway secretions and prolonged anesthesia.

Recent studies have identified several contributors to POST, including the shape and size of the tracheal tube, cuff pressure, duration of tube placement, and the use of inhalation anesthesia. Changing a patient's position from supine to prone can affect the cuff pressure and displacement of the endotracheal tube (ETT), which may influence the incidence of POST, hoarseness, and cough. Improper positioning can also strain neck muscles, putting pressure on the vocal cords and leading to hoarseness.

To reduce POST incidence, selecting the appropriate tracheal tube size is crucial, with recommended sizes of 6.0 to 7.5 mm for females and 7.0 to 8.0 mm for males. Maintaining cuff pressure between 20-25 mmHg is associated with a lower incidence of POST, as excessive pressure can cause mucosal trauma. Additional strategies include using video laryngoscopy for intubation, administering topical non-steroidal anti-inflammatory drugs (NSAIDs), and using steroids during surgery.

Recent research is exploring the effectiveness of intracuff saline and lignocaine for preventing coughing and POST. Increasing the alkalinity of local anesthetics with sodium bicarbonate can enhance their efficacy, improving diffusion through the ETT cuff. Dexmedetomidine, a selective alpha-2 receptor agonist, has shown promise in reducing cough rates and postoperative pain. Notably, a single dose of gargled dexmedetomidine (0.5 µg/kg) has demonstrated effects comparable to intravenous administration, and intratracheal dexmedetomidine has proven more effective than lidocaine in reducing cough reflex and facilitating smooth extubation.

详细描述

One hundred patients aged between 18 and 75 years, American Society of Anesthesiologists (ASA) physical status I and II patients of either sex, undergoing lumbar spine surgery in the prone position under general anesthesia with endotracheal intubation, will be prospectively investigated. Patients with a history of recent respiratory tract infection, prior medication with analgesics or corticosteroids will be excluded. Other Exclusion criteria will include patients who have preoperative sore throat, hoarseness, and cough, have a nasogastric tube, patients with Mallampati class > 2, and who required more than one attempt for tracheal intubation, or patients had a duration of tracheal intubation of < 60 min or > 300 min, and patients not willing to provide their voluntary written informed consent.

Using a computer-generated random number table, the patients will be randomly allocated into Group A, where the ETT cuff will be filled with dexmedetomidine (n = 50), or Group B, where the ETT cuff will be filled with alkalinized lidocaine (n = 50). An anesthetic nurse, who will not be taking part in the postoperative patient interview and assessment, will prepare the study solution and ETT.

In group A, the ETT cuff will be filled with 4 mL of dexmedetomidine 4 mcg/ml. While in group B, lidocaine 2%, 2 ml will be initially injected into the cuff, and then a supplementary volume of 2 ml of sodium bicarbonate (NaHCO3) 8.4% will be added to obtain the minimal occlusive volume. Patients will be premedicated with IV glycopyrrolate 0.2 mg and IV midazolam 0.03 mg/kg. Non-invasive blood pressure, electrocardiography, pulse oximetry, and patient state index (PSI) using a sedation monitor (SedLine, Masimo Corp, Irvine, CA 92618) will be applied when the patients arrive in the operating room. Anesthesia will be induced with fentanyl 2 μg /kg, propofol 2 mg/kg, and cisatracurium 0.2 mg/kg. The investigators will ventilate all patients with 100% oxygen via a facial mask. The investigators will perform tracheal intubation after confirming adequate muscle relaxation (the absence of movement and jaw relaxation). Endotracheal intubation will be performed with tubes having an internal diameter of 8.0 or 7.5 mm for male patients, and 7.5 or 7.0 mm for female patients.

One experienced anesthesiologist, blinded to the experimental protocol, will perform endotracheal intubation and anaesthesia in all patients during the study. Another anesthesiologist, who was not blinded to the study protocol, although excluded from the data collection, carefully inflated the cuffs in all patients. The cuff pressure will be inflated at the minimal occlusive volume i.e., no air leak around the tube cuff when positive pressure was administered at 20 cm. of water.

Patient's position will be changed from supine to prone for surgery, and the patient's head will be positioned on the sponge face pillow without head rotation. After the position change from supine to prone, the investigator will re-adjust the cuff pressure. Anesthesia will be maintained with 1.5-2.5 vol% sevoflurane and 50% in air. The end-tidal CO2 will be kept between 35 and 40 mmHg. The depth of anesthesia will be monitored and kept between 25 and 50 (PSI Index). units. Oral airway devices will not be used intraoperatively. Once the surgery is completed and the patient is fully awake (with TOF greater than 0.7 and PSI greater than 80), they will be extubated, followed by gentle oropharyngeal suction.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 18 to 75 years
  • American Society of Anesthesiologists (ASA) physical status I and II patients
  • Either sex
  • Undergoing lumbar spine surgery in prone position under general anesthesia with endotracheal intubation.

排除标准

  • Patients with a history of recent respiratory tract infection
  • Prior medication with analgesics or corticosteroids.
  • Patients who have preoperative sore throat, hoarseness and cough, have a nasogastric tube,
  • Patients with Mallampati class > 2 and who required more than one attempt for tracheal intubation or patients had a duration of tracheal intubation of < 60 min or > 300 min and
  • Patients not willing to provide their voluntary written informed consent.

研究组 & 干预措施

Group A, ETT cuff will be filled with dexmedetomidine (n = 50)

Experimental

ETT cuff will be filled with 4 ml of dexmedetomidine 4 mcg/ml.

干预措施: Dexmedetomidine (Precedex) (Drug)

Group B, ETT cuff will be filled with alkalinized lidocaine (n = 50)

Active Comparator

lidocaine 2%, 2 ml will be initially injected into the cuff, and then a supplementary volume of 2 ml of sodium bicarbonate (NaHCO3) 8.4% will be added

干预措施: alkalinized lidocaine (Drug)

结局指标

主要结局

the incidence and severity of POST, hoarseness, cough

时间窗: Day 1 postoperative

The primary outcome will be the incidence and severity of POST, hoarseness, cough will be assessed for 1st, 6th, 12th and 24th hour after extubation. The assessment will be done by the on-call anesthesiology resident who was blinded of the study group. The severity of POST, hoarseness, and cough will be graded using a 4-point scale (0: no, 1: minimal, 2: moderate, 3: severe) (Table 1) (15). Any patient will develop post-operative sore throat will be given dexamethasone 8 mg IV stat and advised warm normal saline gargles.

次要结局

  • hemodynamic parameters(Day 1 postoperative)

研究者

发起方
Prince Sultan Military Medical City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Daabiss

CONSULTANT ANESTHESIA, Principal Investigator

Prince Sultan Military Medical City

研究点 (1)

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