Comparison of effect of Subanesthetic dose of Intravenous Ketamine + Lignocaine versus Intravenous Dexmedetomidine on the intubating conditions and hemodynamic stability in awake fiberoptic intubation for anticipated difficult airway: a randomized clinical study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Intubating conditions in terms of Modified Observer Assessment of Alertness/Sedation(OAA/S) score,Endoscopy time, Intubation time, Endoscopist satisfaction score,Patient Discomfort score, Patient Recall of procedure
研究概览
简要总结
This study investigates the comparative effects of subanesthetic intravenous (IV) ketamine plus lignocaine versus IV dexmedetomidine on intubating conditions and hemodynamic stability during awake fiberoptic intubation (AFOI) for anticipated difficult airways. The study is a randomized, triple-blinded clinical trial involving 68 patients aged 18-60 with anticipated difficult airways. Participants will be assigned to receive either a combination of IV ketamine (0.3 mg/kg bolus followed by 0.3 mg/kg/hr infusion) and lignocaine (1.5 mg/kg bolus followed by 1.5 mg/kg/hr infusion) or IV dexmedetomidine (1 mcg/kg over 10 minutes followed by 0.2-0.7 mcg/kg/hr infusion). Primary outcomes include the effectiveness of achieving optimal intubating conditions, assessed by Modified Observer’s Assessment of Alertness/Sedation (OAA/S), endoscopy and intubation times, endoscopist satisfaction, and patient discomfort. Secondary outcomes include hemodynamic parameters, opioid requirements, and incidence of adverse events. The study aims to determine if the ketamine-lignocaine combination offers superior intubating conditions and better hemodynamic stability compared to dexmedetomidine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •1.Patients posted for elective surgeries 2.Patients with ASA status of 1 and 2 3.Patients with Anticipated Difficult Airway with El‑Ganzouri Score 4–12.
排除标准
- •Patients unwilling to give consent for the study
- •Patients with contraindications for awake fiberoptic intubation such as history of coagulopathies, base of skull fracture
- •Patients allergic to study medications
- •Patients with coexisting diseases like uncontrolled hypertension, asthma, history of MI,CAD, shock, heart blocks, heart failure
- •Pregnant women.
结局指标
主要结局
Intubating conditions in terms of Modified Observer Assessment of Alertness/Sedation(OAA/S) score,Endoscopy time, Intubation time, Endoscopist satisfaction score,Patient Discomfort score, Patient Recall of procedure
时间窗: OAA/S score-Immediately before intubation | Endoscopy time-from insertion of scope to carina visualization | Intubation Time-from ET tube insertion to fiberscope is removed | Endoscopist satisfaction-immediately after intubation | Patient Discomfort score- During intubation | Patient recall- 24 hours postoperatively
次要结局
- Hemodynamic Parameters(Heart rate, Mean Arterial Pressure, Oxygen Saturation)(Baseline, after achieving desired sedation level, 1 minute intervals during the procedure, immediately after securing the endotracheal tube)
- Opioid requirement during procedure(End of the procedure)
- Incidence of adverse events(24 hours postoperatively)
研究者
Dr. Tarun Ponugoti
All India Institute of Medical Sciences