PROSPECTIVE RANDOMIZED COMPARATIVE STUDY BETWEEN THREE DIFFERENT DOSES OF DEXMEDETOMIDINE ON INTUBATION CONDITIONS IN AWAKE NASOTRACHEAL FIBREOPTIC BRONCHOSCOPY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The primary objective is to compare between three groups: Intubation score, patients’ tolerance, 3-point assessment score immediately after nasotracheal intubation, hemodynamic parameters and incidence of oxygen desaturation if any.
研究概览
简要总结
Awake nasal fiberoptic intubation (ANFOI) is anestablished method of securing difficult airway recommended for patients withanticipated difficult airway, failed intubation, unstable cervical spine injurywhere optimum positioning for laryngoscopy is difficult to achieve. Bothoptimal intubating conditions and patients’ comfort are paramount while preparingthe patient for fiberoptic intubation. It is essential to prepare the patientsprior to ANFOI. The preparation includes obtundation of airway reflexes,adequate sedation, anxiolysis along with preservation of patent airway andadequate ventilation.
In the present study we will compare three differentdoses of dexmedetomidine for conscious sedation during ANFOI in adult patientsscheduled for elective oro-maxillo-facial and oral malignancy surgeries. Invery few studies dexmedetomidine is used as a single agent for induction forsedation during awake ANFOI. We evaluate 3 different doses of dexmedetomidineto establish conscious safe regimen of sedation
Hence, this study was undertaken to compare thedifferent doses of dexmedetomidine for evaluating intubating conditions duringANFOI
The aim of our study is to compare the effectivenessof different doses of dexmedetomidine for evaluating intubation condition,patient’s tolerance, hemodynamic parameters and incidence of oxygendesaturation, if any.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1All patient giving consent 2Patient undergoing elective oro-maxillo-facial and oral malignancy surgeries 3Patients >18 years or <60 years 4Patients of either sex 5ASA grade I and II.
排除标准
- •1Patients not consenting 2Patient with coagulopathies or on anticoagulants 3Nasal mass or Adenoids 4Patients with severe renal, hepatic, respiratory or cardiac diseases, infection at the site of the block, pregnancy and neuromuscular disorders 5Patients with any known allergy to dexmedetomidine 6Patients with any contraindication to dexmedetomidine 7Lack of cooperation or effective communication.
结局指标
主要结局
The primary objective is to compare between three groups: Intubation score, patients’ tolerance, 3-point assessment score immediately after nasotracheal intubation, hemodynamic parameters and incidence of oxygen desaturation if any.
时间窗: To compare pre infusion, 5 mins after infusion, 10 mins after infusion, pre intubation, during intubation and post intubation
To compare between three different doses of dexmedetomidine for sedation on intubation condition in awake nasotracheal fiberoptic intubation.
时间窗: To compare pre infusion, 5 mins after infusion, 10 mins after infusion, pre intubation, during intubation and post intubation
次要结局
- Secondary objective is to observe side effects of drug, if any(1.5 years)