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

NCT01744184 | Terminated Phase 4 Results DMC

• 1 other identifier: ENT1
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patients Requiring Diagnostic Gastroscopy With Sedation

Keywords

gastroscopy; diagnostic; entonox

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Mild or no Discomfort During Gastroscopy

  Percentage of patients with a score of 4 or 5 on the 5-point modified global rating scale comfort score, as measured by the patient, will be compared between the midazolam and entonox groups, per protocol. The comfort score ranges from 1-5 with 1 meaning patient was in extreme discomfort frequently during procedure and 5 being no discomfort, resting comfortably throughout. The score is completed by the patient while they are in the recovery area post procedure and prior to discharge from the unit.

  During gastroscopy procedure

Secondary Outcomes (6)

• Number of Participants With Completed Procedures in Both Arms of the Study.

  Day of procedure

• Comparison of Procedure Time

  Defined as start time to end time of gastroscopy.

• Comparison of Procedure Start Time to Discharge.

  Procedure to discharge

• Number of Patients With Adverse Events.

  Consent to 72 hours post discharge from the endoscopy unit which is the same day as the procedure.

• Comparison of Visual Analogue Scale Scores.

  Completed after procedure completion during the post-procedure care and prior to discharge from the endoscopy unit.

Study Arms (2)

Midazolam

ACTIVE COMPARATOR

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

Entonox

EXPERIMENTAL

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

Interventions

Entonox DRUG

Entonox arm

Also known as: Oxygen 50.0% +/- 2.0%, Nitrous oxide 50.0% +/- 2.0%

Entonox

Midazolam DRUG

up to 5mg midazolam as appropriate

Also known as: Midazolam 1mg/ml Solution for Injection

Midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Royal Bournemouth Hospital: lead

Study Sites (1)

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

MeSH Terms

Conditions

Disease

Interventions

Entonox; Oxygen; Nitrous Oxide; Midazolam; Solutions; Injections

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr Simon McLaughlin
• Organization: University Hospitals Dorset NHS Foundation Trust

Simon.McLaughlin@uhd.nhs.uk

01202303626

Study Officials

• Simon McLaughlin, MD

  The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 6, 2012
• Study Start: May 1, 2013
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: November 12, 2024
• Results First Posted: November 12, 2024

Record last verified: 2024-09

Locations

GB (1)