Clinical trial NCT01744184: A Single-centre Study of Entonox Versus Midazolam Sedation in Gastroscopy
Official title: A Single-centre, Randomised Controlled Study of Entonox Versus Midazolam Sedation in Gastroscopy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Patients Requiring Diagnostic Gastroscopy With Sedation
Keywords: gastroscopy
diagnostic
entonox
Lead sponsor: The Royal Bournemouth Hospital
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients Mild or no Discomfort During Gastroscopy
timeFrame: During gastroscopy procedure
Secondary outcomes:
measure: Number of Participants With Completed Procedures in Both Arms of the Study.
timeFrame: Day of procedure
measure: Comparison of Procedure Time
timeFrame: Defined as start time to end time of gastroscopy.
measure: Comparison of Procedure Start Time to Discharge.
timeFrame: Procedure to discharge
measure: Number of Patients With Adverse Events.
timeFrame: Consent to 72 hours post discharge from the endoscopy unit which is the same day as the procedure.
measure: Comparison of Visual Analogue Scale Scores.
timeFrame: Completed after procedure completion during the post-procedure care and prior to discharge from the endoscopy unit.
measure: 5-point Modified Global Rating Scale Comfort Nurse Score
timeFrame: Completed after procedure completion during the post-procedure care and prior to discharge from the endoscopy unit.
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
state: Dorset
Study officials:
affiliation: The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
name: Simon McLaughlin, MD
role: PRINCIPAL_INVESTIGATOR
References: