Sedation Using Dexmedetomidine With or Without Different Methods of Airway Topical Anesthesia for Awake Fiberoptic Nasal Intubation in Patients Undergoing Elective Surgeries Under General Anesthesia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Assessment of patients' intubation condition during awake fiberoptic intubation.
研究概览
简要总结
Airway management is an integral part of general anesthesia. Difficult airway management may lead to various adverse events such as airway trauma, up to cardiopulmonary arrest.
Awake fiberoptic intubation is the gold standard technique for difficult airway, although it can lead to significant patient anxiety and discomfort. Thus, it necessitates sufficient airway anesthesia for the patient's comfort and cooperation.
One challenge associated with this procedure is providing adequate anxiolysis while maintaining a patent airway and adequate ventilation. Suppressing airway reflexes represents another challenge to achieve successful airway management.
Sedation can be used during such procedures for better patient cooperation. The ideal sedative for awake intubation would provide patient comfort and good intubating conditions and at the same time maintain a patent airway.
Dexmedetomidine is a selective alpha-2-adrenoceptor agonist that can cause sedation, anxiolysis, sparing with minimal respiratory depression. It reduces the salivary secretion, which is advantageous for awake fiberoptic intubation.
Airway nerve blocks are considered technically difficult to perform and generally carry a higher risk of complications, including bleeding, nerve damage, and intravascular injection, but if performed by an experienced anesthesiologist, they would achieve excellent airway anesthesia for successful AFOI.
There are various airway topical techniques such as nebulization, atomization (McKenzie technique), and Spray-As-You- Go technique.
In the present study, we try to find out which is more effective for topicalization to achieve good intubating conditions in patients undergoing awake fiberoptic nasotracheal intubation using different methods of airway topicalization, nebulization, atomization or We used a modification of the McKenzie technique for atomization.
详细描述
-Type of the Study: Prospective randomized double-blind controlled clinical trial.
- Randomization: 56 patients were included in this prospective randomized double-blind controlled clinical study. They were randomized by computer-generated randomization table into 4 equal groups (14 patients each):
- Group C (Sedation / Control group) (n=14) patients received only dexmedetomidine as a sedative with placebo airway topicalization by nebulization, atomization, and spray as you go using normal saline 0.9%.
- Group N (Nebulization group) (n=14) patients received dexmedetomidine as a sedative in addition to lidocaine 2% nebulization for airway topicalization and placebo airway topicalization by atomization and spray as you go using normal saline 0.9%.
- Group A (Atomization group) (n=14) patients received dexmedetomidine as a sedative in addition to lidocaine 2% by atomization "modified McKenzie technique" and placebo airway topicalization by nebulization and spray as you go using normal saline 0.9%.
- Group S (SAYGo group) (n=14) patients received dexmedetomidine as a sedative in addition to lidocaine 2% by "Spray As You Go" technique and placebo airway topicalization by atomization and nebulization using normal saline 0.9%.
A well-trained nurse prepared different topicalization methods according to each group. The anesthesiologist who performed the awake fiberoptic nasal intubation and followed the perioperative data was unaware of each preparation, as well as the patient to ensure blindness of the study.
- Preoperative Preparation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient acceptance and willingness to sign a written informed consent document.
- •Body mass index (BMI): 18.5 - 24.9 kg/m
- •American Society of Anesthesiologists physical status: class I & II.
- •patients undergoing elective surgery under general anesthesia.
排除标准
- •Patient refusal.
- •Patients with known allergies to study drugs.
- •Patients having any contraindication to nasal intubation; nasal bleeding or infection.
- •Patients having bleeding disorders.
- •Reactive airway disease.
研究组 & 干预措施
Group C (Sedation / Control group)
The patients will receive only dexmedetomidine as a sedative for AFOI with placebo airway topicalization by nebulization, atomization and spray as you go using normal saline 0.9%.
干预措施: Dexmedetomidine Hydrochloride (Drug)
Group N (Nebulization group)
The patients will receive dexmedetomidine as a sedative in addition to lidocaine 2% nebulization for airway topicalization and placebo airway topicalization by atomization and "spray as you go" using normal saline 0.9%.
干预措施: Dexmedetomidine Hydrochloride (Drug)
Group N (Nebulization group)
The patients will receive dexmedetomidine as a sedative in addition to lidocaine 2% nebulization for airway topicalization and placebo airway topicalization by atomization and "spray as you go" using normal saline 0.9%.
干预措施: Nebulization (Other)
Group A (Atomization group)
The patients will receive dexmedetomidine as a sedative in addition to lidocaine 2% by atomization "modified McKenzie technique" and placebo airway topicalization by nebulization and "spray as you go" using normal saline 0.9%.
干预措施: Dexmedetomidine Hydrochloride (Drug)
Group A (Atomization group)
The patients will receive dexmedetomidine as a sedative in addition to lidocaine 2% by atomization "modified McKenzie technique" and placebo airway topicalization by nebulization and "spray as you go" using normal saline 0.9%.
干预措施: Atomization (Other)
Group S (SAYGo group)
The patients will receive dexmedetomidine as a sedative in addition to lidocaine 2% by "Spray as You Go" technique and placebo airway topicalization by atomization and nebulization using normal saline 0.9%.
干预措施: Dexmedetomidine Hydrochloride (Drug)
Group S (SAYGo group)
The patients will receive dexmedetomidine as a sedative in addition to lidocaine 2% by "Spray as You Go" technique and placebo airway topicalization by atomization and nebulization using normal saline 0.9%.
干预措施: Spray-As-You-Go (Other)
结局指标
主要结局
Assessment of patients' intubation condition during awake fiberoptic intubation.
时间窗: 1 - 3 hours
The patients' intubation condition is assessed by the Five-point fiberoptic intubation comfort score
次要结局
- Calculation of the total dexmedetomidine dose used for sedation(20 minutes)
- Peri-intubation measurement of mean arterial pressure .(1 hour)
- Peri-intubation measurement of heart rate.(1 hour)
- Evaluation the post-operative patient satisfaction(1 hour)
