Evaluation of Nitrous Oxide Use in GI Endoscopy Procedures: Potential for Optimizing Sedation and Minimizing Side-Effects During Recovery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intravenous sedative drug
研究概览
简要总结
Nitrous oxide (commonly known as 'laughing gas') is often used during dental and other outpatient procedures, because it is easy to administer, is short-acting and rapidly clears from the body following the procedure.
The investigators hypothesize that use of Nitrous oxide during GI endoscopy may enhance patient comfort during the procedure and speed-up post-procedure recovery, while minimizing the fatigue and mental fogginess some patients report the day after receiving standard sedative and narcotic drugs used routinely for the procedure.
The investigators are interested in determining if adding Nitrous Oxide to commonly used sedation drugs will decrease fatigue, mental fogginess, and nausea/vomiting, as well as determine when the patient felt fully recovered from the effects of all sedatives given for the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
The patient and healthcare providers (e.g. gastroenterologist performing the procedure and nurse administering conscious sedation) will not know if the patient is receiving either 5% or 50% inhaled nitrous oxide
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
- •Non-pregnant patients age 18 and older
- •Patient's presenting for upper endoscopy or colonoscopy under endoscopist- directed nurse sedation.
- •Patient is willing and able to consent and comply with study procedures.
排除标准
- •Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
- •Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
- •Allergy to the proposed anesthetic agents (e.g. nitrous oxide, midazolam, fentanyl, diphenhydramine)
研究组 & 干预措施
5% inhaled nitrous oxide
Patients will received 5% nitrous oxide by face mask in addition to standard intravenous sedatives given at the discretion of the care provider.
干预措施: Nitrous oxide (Drug)
50% inhaled nitrous oxide
Patients will received 50% nitrous oxide by face mask in addition to standard intravenous sedatives given at the discretion of the care provider.
干预措施: Nitrous oxide (Drug)
结局指标
主要结局
Intravenous sedative drug
时间窗: Duration of the procedure (1-2 hours)
Tabulate the types and dosages of intravenous sedative drugs given
Nausea/vomiting
时间窗: 24-36 hours
Duration of nausea/vomiting
Recovery time
时间窗: Duration of the procedure (1-3hours)
Time spent in procedure room to recover
Patient comfort
时间窗: Duration of the procedure (1-3hours)
Patient comfort rating intra-procedure using standardized scale
Fatigue
时间窗: 24-36 hours
The duration of fatigue experienced, if any
Mental Fogginess post-procedure/sedation
时间窗: 24-36 hours
Number of patients who experienced mental fogginess post-procedure/sedation
Return to baseline function
时间窗: 24-36 hours
Number of hours post-procedure/sedation for patient to return to baseline function
次要结局
未报告次要终点
研究者
Tim Angelotti
Associate Professor of Anesthesiology, Perioperative and Pain Medicine
Stanford University