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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by The Royal Bournemouth Hospital
Sponsor:
Information provided by (Responsible Party):
The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier:
NCT01744184
First received: December 4, 2012
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Patients Requiring Diagnostic Gastroscopy Suitable for Sedation.
Drug: Entonox
Drug: Midazolam
Phase 4

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by The Royal Bournemouth Hospital:

Primary Outcome Measures:
  • Patient comfort during gastroscopy [ Time Frame: During gastroscopy procedure ] [ Designated as safety issue: Yes ]
    Patient comfort during gastroscopy confirmed by post procedural questionnaire completion


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
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)
Arms Assigned Interventions
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 Name: 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%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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

Contacts
Contact: Simon McLaughlin, MD 01202704961 simon.mclaughlin@nhs.net

Locations
United Kingdom
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Recruiting
Bournemouth, Dorset, United Kingdom, BH7 7DW
Contact: Simon McLaughlin, MD    01202704961    simon.mclaughlin@nhs.net   
Contact: James Page    01202726014    james.page@rbch.nhs.uk   
Principal Investigator: Simon McLaughlin, MD         
Sponsors and Collaborators
The Royal Bournemouth Hospital
Investigators
Principal Investigator: Simon McLaughlin, MD The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier: NCT01744184     History of Changes
Other Study ID Numbers: ENT1
Study First Received: December 4, 2012
Last Updated: August 8, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by The Royal Bournemouth Hospital:
gastroscopy
diagnostic
entonox

Additional relevant MeSH terms:
Entonox
Midazolam
Nitrous Oxide
Adjuvants, Anesthesia
Analgesics
Analgesics, Non-Narcotic
Anesthetics
Anesthetics, Combined
Anesthetics, General
Anesthetics, Inhalation
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 29, 2014