Effect of nebulised ketamine in management of acute exacerbation of COPD: A pilot randomised controlled trial.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To evaluate the effect of nebulised ketamine, in addition to standard care, in improving respiratory function in patients with acute exacerbation of chronic obstructive pulmonary disease as measured by the change in peak expiratory flow rate at 0, 15, 30, 60 and 120 min of administration.
研究概览
简要总结
This is a single-blind, randomized controlled Phase II trial designed to evaluate the efficacy and safety of nebulized ketamine as an adjunct to standard therapy in patients presenting with severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Eligible patients presenting to the emergency department with severe AECOPD will be randomly assigned to receive either nebulized ketamine (0.5 mg/kg, max 50 mg in 10 mL NS) or nebulized saline (10 mL NS) every 20 minutes for up to three doses, in addition to standard COPD therapy. The primary outcome is the change in Peak Expiratory Flow Rate (PEFR) from baseline to 60 minutes. Secondary outcomes include dyspnea score (VAS), oxygen saturation, need for non-invasive ventilation or intubation, arterial blood gas and adverse effects within the first 2 hours. The sample size was calculated based on previous randomized trials using ketamine in airway diseases, targeting a total of 70 patients (including 10% attrition).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with known diagnosis of COPD based on GOLD criteria Presentation with acute exacerbation (increased dyspnoea, sputum volume, or purulence) Ability to provide written informed consent.
排除标准
- •Hemodynamic instability (SBP less than 90 mmHg or MAP less than 65 mmHg) Immediate need for endotracheal intubation Glasgow Coma Scale less than 15 Active psychosis or significant psychiatric illness Known allergy or hypersensitivity to ketamine Pregnancy or lactation Chronic kidney disease (stage 4 or 5) Decompensated liver disease Recent myocardial infarction (less than 4 weeks) Tracheostomy or patients already intubated.
结局指标
主要结局
To evaluate the effect of nebulised ketamine, in addition to standard care, in improving respiratory function in patients with acute exacerbation of chronic obstructive pulmonary disease as measured by the change in peak expiratory flow rate at 0, 15, 30, 60 and 120 min of administration.
时间窗: 0 to 120 min where 0 being the time of administration of nebulised ketamine.
次要结局
- To assess the changes in oxygen saturation, respiratory rate and arterial blood gas parameters with in 120 mins.(0 to 120 min where 0 being the time of administration of nebulised ketamine.)
- To evaluate the time to clinical improvement as judged by visual analogue score with in 120 mins.(0 to 120 min where 0 being the time of administration of nebulised ketamine.)
- To determine the need for escalation of respiratory support to mechanical ventilation.(0 to 120 min where 0 being the time of administration of nebulised ketamine.)
- To monitor for adverse effects like hallucinations, nausea etc. within 120 min.(0 to 120 min where 0 being the time of administration of nebulised ketamine.)
研究者
Akhilesh Singh Chandel
AIIMS New Delhi