A Single-centre, Randomised Controlled Study of Entonox Versus Midazolam Sedation in Gastroscopy.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Percentage of Patients Mild or no Discomfort During Gastroscopy
研究概览
简要总结
This study aims to determine whether Entonox (gas and air) is at least as good as intravenous midazolam in providing analgesia and sedation during gastroscopy. Entonox is used as an adjunct in lower gastrointestinal procedures but is not routinely used in gastroscopy, and there is only one similar published study to date, which was performed in children. The main advantage of Entonox over midazolam is the quick recovery time following withdrawal of the agent, which enables patients to return to independent normal life. The investigators would like to be able to offer Entonox to patients as an option for sedation during gastroscopy, this study is being conducted to determine if it is a safe and feasible option.
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
- None
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
- •Male/female aged 18 years or over
- •Confirmed clinical requirement to undergo diagnostic gastroscopy
- •Suitable for sedation
- •Able to provide informed consent
排除标准
- •History of chronic respiratory or significant cardiac disease
- •Requirement for longer procedure eg Barrett's surveillance
- •Previous known adverse reaction to Entonox
- •Entonox use in previous 4 days
- •Known current vitamin B12 or folate deficiency
- •Unable to provide consent
- •Any known contraindication to Entonox:
- •Gas trapped in a part of the body where its expansion may be dangerous, such as air lodged in an artery or artificial traumatic or spontaneous pneumothorax (collapsed lung).
- •Decompression sickness (the bends) or following a recent dive
- •Air encephalography
- •Severe bullous emphysema
- •Myringoplasty
- •Gross abdominal distension
- •Recent severe injuries to the face and jaw
- •Current or recent head injuries
- •If the patient has recently had any eye surgery where injections of gas have been used
研究组 & 干预措施
Midazolam
midazolam sedation combined with pharyngeal anaesthesia
Participants randomized to receive midazolam will have an intravenous cannula sited and, following the administration of xylocaine throat spray as above, will be put into the left lateral position. They will then be given up to 5mg midazolam as appropriate to achieve conscious sedation as for standard protocol in endoscopy.
干预措施: Midazolam (Drug)
Entonox
Entonox combined with pharyngeal anaesthesia.
Pharyngeal anaesthesia, given as 8-16 sprays of xylocaine to the pharynx; 3 minutes will be given to allow the pharynx to become anaesthetized.
Participants randomized to receive Entonox will be given the 50:50 nitrous oxide:oxygen mix via a mouthpiece with a demand valve system, once in position for the procedure. Inhalations will be given for 3-5 minutes (or until the participant feels adequately sedated) measured using a stopwatch. Oxygen will be given at 2 litres per minute via nasal cannulae during the procedure, (standard care for sedated procedures). The endoscopist will then proceed to intubate the cricopharynx and perform the procedure in the standard manner.
干预措施: Entonox (Drug)
结局指标
主要结局
Percentage of Patients Mild or no Discomfort During Gastroscopy
时间窗: During gastroscopy procedure
Percentage of patients with a score of 4 or 5 on the 5-point modified global rating scale comfort score, as measured by the patient, will be compared between the midazolam and entonox groups, per protocol. The comfort score ranges from 1-5 with 1 meaning patient was in extreme discomfort frequently during procedure and 5 being no discomfort, resting comfortably throughout. The score is completed by the patient while they are in the recovery area post procedure and prior to discharge from the unit.
次要结局
- Number of Participants With Completed Procedures in Both Arms of the Study.(Day of procedure)
- Comparison of Procedure Time(Defined as start time to end time of gastroscopy.)
- Comparison of Procedure Start Time to Discharge.(Procedure to discharge)
- Number of Patients With Adverse Events.(Consent to 72 hours post discharge from the endoscopy unit which is the same day as the procedure.)
- Comparison of Visual Analogue Scale Scores.(Completed after procedure completion during the post-procedure care and prior to discharge from the endoscopy unit.)
- 5-point Modified Global Rating Scale Comfort Nurse Score(Completed after procedure completion during the post-procedure care and prior to discharge from the endoscopy unit.)