A Single-centre Study of Entonox Versus Midazolam Sedation in Gastroscopy (NCT01744184) | Clinical Trial Compass
TerminatedPhase 4
A Single-centre Study of Entonox Versus Midazolam Sedation in Gastroscopy
Stopped: Resource issues, Poor recruitment
United Kingdom62 participantsStarted 2013-05
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male/female aged 18 years or over
* Confirmed clinical requirement to undergo diagnostic gastroscopy
* Suitable for sedation
* Able to provide informed consent
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Patients Mild or no Discomfort During Gastroscopy