Effect of Xylometazoline Administration During Nasal Flexible Bronchoscopy: A Double Blind, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Operator rated difficulty in nasal bronchoscope negotiation (VAS)
研究概览
简要总结
Flexible bronchoscopy is a commonly performed procedure and is usually performed transnasally. The optimal topical anesthesia regimen for bronchoscopy is investigational. Topical Vasoconstrictors like xylometazoline produce decongestion of nasal mucosa and may make insertion of bronchoscope easier. The addition of topical vasoconstrictor to lignocaine may have advantage in terms of patient comfort and for reducing local complications. Although evaluated in the settings of nasal endoscopy and nasotracheal intubation, randomized trials on the role of topical vasoconstrictors during flexible bronchoscopy are not available. The aim of this randomized trial is to study the effect of topical nasal xylometazoline administration during flexible bronchoscopy.
详细描述
Study design: Randomized double-blind placebo controlled study Study setting: Bronchoscopy room in Department of pulmonary medicine and sleep disorders at AIIMS, New Delhi Sample size: 200 patients (100 in each arm)
Inclusion criteria:
a) All adults > 18 years of age undergoing flexible bronchoscopy via nasal route
Exclusion criteria:
- Uncontrolled hypertension
- coronary artery disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Concealed envelopes
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adults > 18 years of age undergoing flexible bronchoscopy via nasal route
- •Exclusion criteria:
- •Uncontrolled hypertension
- •coronary artery disease
- •Pregnancy
- •refusal of consent
- •Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3
- •Bronchoscopy not performed by nasal route
- •Bronchoscopy performed through an artificial airway
排除标准
- 未提供
研究组 & 干预措施
Xylometazoline
Patients receiving topical xylometazoline nasally during bronchoscopy
干预措施: Xylometazoline (Drug)
Saline placebo
Patients receiving topical saline nasally during bronchoscopy
干预措施: Saline (Drug)
结局指标
主要结局
Operator rated difficulty in nasal bronchoscope negotiation (VAS)
时间窗: At study completion approximately 4 months
Visual Analogue scale
次要结局
- Assistant rated Faces Pain scale for discomfort on nasal bronchoscope insertion(At study completion approximately 4 months)
- Patient rated nasal pain on procedure completion (VAS)(At study completion approximately 4 months)
- Operator rated nasal mucosal trauma (VAS)(At study completion approximately 4 months)
- Complications(At study completion approximately 4 months)
研究者
Karan Madan
Karan Madan, MD DM, Assistant Professor, Pulmonary Medicine and Sleep Disorders
All India Institute of Medical Sciences, New Delhi