Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cecal intubation rates and time of the procedure - total time and recovery
研究概览
简要总结
Colon cancer is the second most common cancer in men and the third most common cancer in women worldwide. The clinical objectives of administering sedation for GI endoscopy are to relieve patient anxiety and discomfort and to improve the outcome of the examination. Use of N2O could potentially provide an alternate safe and cheap option for patients who do not prefer IV sedation for colonoscopy
详细描述
Patients who are considered low risk for anesthesia administration (ASA class <IV) receive moderate sedation with a combination of intravenous benzodiazepine and opioid medication. an alternative method of providing analgesia with "on-demand" inhalation of nitrous oxide (hereafter referred to as N2O) combined with oxygen has been postulated. Nitrous Oxide has been used for analgesia in various procedures including childbirth, general anesthesia, pediatric dentistry, bone marrow aspiration, fracture reductions, and minor surgical procedures (surgical dressings, pulmonary endoscopy, an abscess . It could potentially reduce overall costs for the procedure, in addition to providing a quicker recovery, turn over
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women, more than 18 years old Scheduled for a colonoscopy at the Endoscopy unit
排除标准
- •High ASA risk (IV/ >)
- •History of chronic pain
- •Allergy to N2O or opioid or BDZ
- •No consent
- •Recent head injury with impairment of consciousness or Intracranial / Middle Ear surgery within the previous 6 months with or without residual deficits.
- •Pneumothorax, air embolism
- •Decompression sickness or within 48 hours of an underwater dive
- •Severe emphysema with bullae
- •Gross abdominal distension with suspicion for bowel obstruction
- •Intoxication
- •Maxillofacial injuries (where patient unable to administer the drug using a mouthpiece/mask, or there is the risk of causing further damage to facial wounds and there may also be a significant risk of blood inhalation)
- •Patients with chronic pulmonary disease for whom an inspired oxygen concentration of more than 28% oxygen might be dangerous
- •Patients on Methotrexate
- •Where patients need assistance to hold the mask or mouthpiece.
- •Retinal surgery within the last three months
- •Any patient who does not otherwise clinically qualify for standard sedation methods (i.e., those who require general anesthesia)
研究组 & 干预措施
Nitrous Oxide
Patient receiving Nitrous Oxide are evaluated for success of the procedure
干预措施: Nitrous Oxide (Drug)
IV Sedation group
In this group a combination of Midazolam and Fentanyl is used per endoscopic discretion
干预措施: Nitrous Oxide (Drug)
结局指标
主要结局
Cecal intubation rates and time of the procedure - total time and recovery
时间窗: 1 to 30 minutes
Time required to complete the procedure and reach end of the colon
次要结局
未报告次要终点