Effect of an Adjunctive Sedative for the Patients With Histories of Paradoxical Reaction to Midazolam During Sedative Endoscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Occurrence of severe paradoxical reaction (>= level 3)
研究概览
简要总结
This single-blind prospective study is aimed to investigate the effect of antihistamine as an adjunctive sedative for the patients with histories of severe paradoxical reaction to midazolam during sedative endoscopy. Participating patients are to receive antihistamine intravenously in addition to midazolam. The primary outcome is the reduction of paradoxical reaction in the antihistamine combination group. The secondary outcome is to compare sedation quality, performance quality, reduction of total midazolam dose will be analyzed between antihistamine combination and midazolam only group.
详细描述
The present study will be conducted at Seoul National University Hospital Gangnam center between May 2019 and April 2020. Participants who have histories of paradoxical reaction to sedative endoscopy in medical record gave consent on the day of the endoscopy and were assigned to receive the combination of chlorpheniramine (4-6mg) with midazolam(1-10mg) Meanwhile, the patients do not want the use of chlorpheniramine and were assigned to midazolam alone as routine clinical practice. Research medication (chlorpheniramine) was administered 2 to 3 minutes before the administration of midazolam outside of endoscopy room. The blinded endoscopist and assistant nurse are going to perform induction for moderate sedation using incremental doses of the intravenous midazolam (1-2 mg) given every 2 minutes. The endoscopists and assistant nurses will assess the occurrence of severe paradoxical reaction (Grade 3) and other major quality outcomes (procedure/intubation time, sedation quality, completeness of procedure [10 Key image documentation], the satisfaction of procedure, side effects). The endoscopists and nurses will individually rate outcome measure using a 5-point Likert scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previous histories of the paradoxical reaction during a sedative endoscopic examination
排除标准
- •inability to execute informed consent
- •allergic to antihistamine agent
- •pregnancy
- •severe cardiopulmonary disease
- •prior administration of antihistamine on the same day
研究组 & 干预措施
antihistamine combination
Participants in this group will get combination chlorpheniramine and midazolam injection for sedative endoscopy.
干预措施: Chlorpheniramine and midazolam (Drug)
midazolam
Participants in this group will get only midazolam injection for sedative endoscopy
干预措施: Midazolam (Drug)
结局指标
主要结局
Occurrence of severe paradoxical reaction (>= level 3)
时间窗: 1 day
(1) irrational talking or increased talkativeness such as mumbling to himself/herself; (2) restlessness or loss of cooperation such as resisting the insertion of endoscope or trying to bite the scope; (3) excessive movement requiring repositioning such as jerking or swinging movements of the arms and legs or trying to draw out the scope or mouthpiece; and (4) hostile action such as trying to strike the endoscopists or attending nurses.
次要结局
- completeness of procedure(1 day)
- adverse events(1 day)
- Dose of midazolam(1 day)
- Satisfaction for the procedure(1 day)
- procedure/intubation time(1 day)
- Satisfaction for Quality of sedation(1 day)
研究者
Su Jin Chung
Professor
Seoul National University Hospital