Oropharyngeoesophageal Topical Anesthesia Prototype Device Versus Intravenous (Propofol - Ketamine Sedation) for Upper Gastrointestinal Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Patient discomfort felt during endoscopy
研究概览
简要总结
Esophagogastroduodenoscopy (EGD) is an essential and widely used diagnostic and therapeutic procedure in gastroenterology. EGD can be performed in association with topical anesthesia of the pharynx, intravenous anesthesia, or with their combination. Sedation is required to alleviate anxiety, provide analgesia, amnesia and to improve endoscopic performance specifically in therapeutic procedures. However, sedation-related gastrointestinal endoscopy complications when occur, may lead to significant morbidity and occasional mortality especially with moderate and deep sedation. Cardiopulmonary complications resulting from aspiration, oversedation, hypoventilation, vasovagal reflex, and airway obstruction account for more than 50% of all complications associated with upper endoscopy. Topical pharyngeal anesthesia currently is a requirement for upper endoscopy to provide patients with the best comfort in unsedated EGD. In Hong Kong, 10% Xylocaine pump spray (AstraZeneca, Sodertalje, Sweden) is the pharyngeal anesthesia generally used as a premedication in unsedated EGD. The aim of this study was to provide more effective, safer, tolerable and offers quicker recovery technique using either the modified Oropharyngeoesophageal Topical Anesthesia (OPETA) technique or conventional intravenous sedation by prepared mixture of propofol and ketamine (ketofol 4:1) .
详细描述
This Randomized prospective clinical study was conducted at Zagazig University Hospitals in anesthesia, intensive care and pain management department at the outpatient endoscopy unit service at general medicine department on 60 patients scheduled to undergo elective upper GI endoscopy. All upper GI endoscopy procedures was preformed by OLYMPUS EVIS EXERA III CV- 190 .Written informed consent was obtained from all participants.
According to a computer-generated randomization table, patients were allocated to two equal groups (30 patients in each group). Group (PK): Included 30 patients received intravenous sedation using prepared mixture of propofol and ketamine (in the ratio 4:1).
Group (OPETA):
Included 30 patients underwent modified Oropharyngeo-esophygeal Topical Anesthesia by OPETA Prototype tool (Nofal 2010).
All participants were subjected to:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes. Patients aged between 21-64 years old undergoing elective upper GI endoscopy after taking informed consent. ASA class II /III BMI < 30kg/m2
排除标准
- •Hypersensitivity to drugs included in the study. Difficult airway or known airway problems. Active bleeding from esophageal varices. Emergency procedure Low base line oxygen saturation < 92% at room air. Cases expected to need general anesthesia for the procedure as judged by endoscopist.
结局指标
主要结局
Patient discomfort felt during endoscopy
时间窗: Endoscopy time: Time from starting of insertion till removal of the endoscope
0-10 numeric rating scale was the measurement scale where 0 means the procedure was extremely comfortable and 10 means that it was extremely uncomfortable.
次要结局
- Overall technical difficulty of the examination(Endoscopy time: Time from starting of insertion till removal of the endoscope)
- Difficulty in introducing the endoscope(Endoscopy time: Time from starting of insertion till removal of the endoscope)
- Difficulty in insertion of OPETA device(OPETA time: Time from administration of self or helped oral topical anesthesia till getting the OPETA device manipulation tolerated by the patient (moving the OPETA tool up and down clockwise and anti-clockwise without distressing the patient).)
研究者
Ashraf Torki
Lecturer of Anesthesia, Zagazig University
Zagazig University