A randomised controlled double-blinded study comparing intubation conditions, patient comfort, and hemodynamic stability with Dexmedetomidine, Fentanyl, and Ketamine when combined with Midazolam during awake fiberoptic intubation.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- To determine the most effective sedative combination for improving intubation conditions during awake fiberoptic intubation.
研究概览
简要总结
Awake fiberoptic intubation is used in anticipated difficult airways but requires adequate sedation for patient comfort and stable hemodynamics. Midazolam is often combined with dexmedetomidine, fentanyl, or ketamine, but the best combination is unclear. This randomized double-blind trial will compare these three drug combinations in 75 adults. The primary outcome is intubation conditions. Secondary outcomes include patient comfort, sedation level, hemodynamic stability, and adverse effects. The study aims to identify the most effective and safest sedative regimen for awake fiberoptic intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 to 65 requiring awake fibreoptic intubation.
- •ASA Physical Status I–III.
- •Patients giving informed consent.
- •Patients with an anticipated difficult airway based on clinical predictors (e.g., limited mouth opening, restricted neck movement, high Mallampati grade, facial anomalies, or history of difficult intubation).
排除标准
- •Participants refused to sign informed consent.
- •ASA Physical Status IV-V.
- •Severe cardiovascular instability.
- •Pregnant or lactating women.
- •Patients with increased intracranial or intraocular pressure.
结局指标
主要结局
To determine the most effective sedative combination for improving intubation conditions during awake fiberoptic intubation.
时间窗: To determine the most effective sedative combination for improving intubation conditions during awake fiberoptic intubation at baseline, 5min, 10min, 15min,30min
次要结局
- Hemodynamic Stability(Hemodynamic parameters will be recorded at baseline (pre-drug), after premedication, 5 min and 10 min after infusion start, during topical anaesthesia, bronchoscope insertion, intubation, 15 min and 30 min post-intubation, every 30 min till end of surgery, at post-extubation (0 min), 15 min and 30 min post-extubation.)
- Patient Comfort / Sedation (Modified OAA/S score)(Sedation score (Modified OAA/S) will be assessed at the end of loading dose infusion, before intubation, and after intubation.)
研究者
Dr Lovejeet Rathee
Pacific Medical College and Hospital