A Single-centre Study of Entonox Versus Midazolam Sedation in Gastroscopy

January 27, 2020 updated by: The Royal Bournemouth Hospital

A Single-centre, Randomised Controlled 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH7 7DW
        • Recruiting
        • The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
        • Contact:
        • Contact:
        • Principal Investigator:
          • Simon McLaughlin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male/female aged 18 years or over
  • Confirmed clinical requirement to undergo diagnostic gastroscopy
  • Suitable for sedation
  • Able to provide informed consent

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Midazolam
up to 5mg midazolam as appropriate
Other Names:
  • Midazolam 1mg/ml Solution for Injection
Experimental: Entonox

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.
Drug: Entonox
Entonox arm
Other Names:
  • Oxygen 50.0% +/- 2.0%
  • Nitrous oxide 50.0% +/- 2.0%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient comfort during gastroscopy
Time Frame: During gastroscopy procedure
Patient comfort during gastroscopy confirmed by post procedural questionnaire completion
During gastroscopy procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of completed procedures in both arms of the study.
Time Frame: 3 months
The number of completed procedures in both arms of the study confirmed by data collection.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Royal Bournemouth Hospital

Investigators

  • Principal Investigator: Simon McLaughlin, MD, The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

December 4, 2012

First Submitted That Met QC Criteria

December 5, 2012

First Posted (Estimate)

December 6, 2012

Study Record Updates

Last Update Posted (Actual)

January 29, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENT1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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