A Single-centre Study of Entonox Versus Midazolam Sedation in Gastroscopy
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.
Patients Requiring Diagnostic Gastroscopy Suitable for Sedation.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single-centre, Randomised Controlled Study of Entonox Versus Midazolam Sedation in Gastroscopy.|
- Patient comfort during gastroscopy [ Time Frame: During gastroscopy procedure ] [ Designated as safety issue: Yes ]Patient comfort during gastroscopy confirmed by post procedural questionnaire completion
- Number of completed procedures in both arms of the study. [ Time Frame: 3 months ] [ Designated as safety issue: No ]The number of completed procedures in both arms of the study confirmed by data collection.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Active Comparator: 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.
up to 5mg midazolam as appropriate
Other Name: Midazolam 1mg/ml Solution for Injection
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744184
|Contact: Simon McLaughlin, MDfirstname.lastname@example.org|
|The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust||Recruiting|
|Bournemouth, Dorset, United Kingdom, BH7 7DW|
|Contact: Simon McLaughlin, MD 01202704961 email@example.com|
|Contact: James Page 01202726014 firstname.lastname@example.org|
|Principal Investigator: Simon McLaughlin, MD|
|Principal Investigator:||Simon McLaughlin, MD||The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust|