A study of Entonox versus midazolam in upper GI endoscopy

• Research type

  Research Study

• Full title

  A single-centre, randomised controlled study of Entonox versus midazolam in upper GI endoscopy.

• IRAS ID

  101675

• Contact name

  Simon McLaughlin

• Sponsor organisation

  The Royal Bournemouth & Christchurch Hospitals NHS

• Eudract number

  2012-002242-20

• ISRCTN Number

  n/a

• Research summary

  Patients who require a gastroscopy have the options of intravenous sedation (using midazolam) and/or local anaesthetic throat spray. Midazolam reduces anxiety and promotes amnesia but has some hangover effects which, according to national guidelines, mean patients are deemed unsafe to drive or work for 24 hours after the procedure and require both a responsible adult to accompany them home and to stay with them for 12 hours. Local anaesthesia of the pharynx has no anxiolytic effect and is acceptable to some patients, and has the advantage of lasting for around 1 hour with no other effects. Entonox is a mix of nitrous oxide and oxygen (gas and air), and has long been used in a variety of settings for short-lived pain relief with sedative and amnesic properties. The advantages of Entonox over traditional sedation with midazolam are that patients are deemed fit to drive 30 minutes after their procedure. In addition they do not require a responsible adult to accompany them home and can return to work the same day. This has obvious benefits especially in those who are self-employed. In addition the reduced recovery time may have a positive impact on Endoscopy Department throughput. The aims of this study are to establish whether Entonox and anaesthetic throat spray could provide levels of patient comfort, and procedure completion rates, equal to that of midazolam sedation and anaesthetic throat spray. If Entonox is shown to be as effective as midazolam then it can be offered as an option for patients undergoing a gastroscopy in future.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  12/LO/0886

• Date of REC Opinion

  5 Jul 2012

• REC opinion

  Favourable Opinion