A Single-centre Study of Entonox Versus Midazolam Sedation in Gastroscopy
This study has suspended participant recruitment.
Information provided by (Responsible Party):
The Royal Bournemouth Hospital
First received: December 4, 2012
Last updated: April 11, 2017
Last verified: April 2017
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 With Sedation
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
||A Single-centre, Randomised Controlled Study of Entonox Versus Midazolam Sedation in Gastroscopy.
Primary Outcome Measures:
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2018 (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.
- Oxygen 50.0% +/- 2.0%
- Nitrous oxide 50.0% +/- 2.0%
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Male/female aged 18 years or over
- Confirmed clinical requirement to undergo diagnostic gastroscopy
- Suitable for sedation
- Able to provide informed consent
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744184
|The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
|Bournemouth, Dorset, United Kingdom, BH7 7DW |
The Royal Bournemouth Hospital
||Simon McLaughlin, MD
||The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
||The Royal Bournemouth Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 4, 2012
||April 11, 2017
Keywords provided by The Royal Bournemouth Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 27, 2017
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Sensory System Agents
Peripheral Nervous System Agents