A Single-centre Study of Entonox Versus Midazolam Sedation in Gastroscopy
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 2017|
|Estimated Primary Completion Date:||April 2017 (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|