A study to see if gas and air (Entonox) is as good as conventional sedation (midazolam given into the vein) in gastroscopy (telescopic camera exmination of the stomach).

• Conditions: Any patient with symptoms requiring investigation with a gastroscopy. There is no single condition to which this would apply.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2012-002242-20-GB
• Lead Sponsor: Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-02
• Last Update Posted: 1 April 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Male/female aged 18 years or over Confirmed clinical requirement to undergo diagnostic gastroscopy Suitable for sedation Able to provide informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish whether Entonox and local anaesthetic throat spray could provide levels of patient comfort at least as good as that of midazolam sedation and local anaesthetic throat spray when performing gastroscopy.;Secondary Objective: To establish whether completion rates of gastroscopy using Entonox and local anaesthetic throat spray are at least as good as those performed with midazolam.;Primary end point(s): Patient comfort during gastroscopy.;Timepoint(s) of evaluation of this end point: Interim evaluation every month and final evaluation 6 months after commencement of study.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Completion rates of procedure.;Timepoint(s) of evaluation of this end point: Interim evaluation every month and final evaluation 6 months after commencemnt of study.