Patients Requiring Diagnostic Gastroscopy With SedationPhase 4NCT01744184

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

A Phase 4 study testing Entonox and Midazolam in people with Patients Requiring Diagnostic Gastroscopy With Sedation, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Patients Requiring Diagnostic Gastroscopy With Sedation
What is being tested?: Entonox and Midazolam
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteUnited Kingdom
Study dates: May 2013to 28 Feb 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth, Dorset, BH7 7DW

Other trials in United Kingdom

About this study

Official title: 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.

Conditions: Patients Requiring Diagnostic Gastroscopy With Sedation
Being tested: Entonox, Midazolam
Keywords: gastroscopy, diagnostic, entonox
Medical subject headings: Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EntonoxDrug
Also called Oxygen 50.0% +/- 2.0%, Nitrous oxide 50.0% +/- 2.0%
Entonox arm
MidazolamDrug
Also called Midazolam 1mg/ml Solution for Injection
up to 5mg midazolam as appropriate

Study groups in NCT01744184
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Entonox

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: During gastroscopy procedure

Secondary outcomes (6)

Number of Participants With Completed Procedures in Both Arms of the Study.
The percentage of participants with completed procedures in both arms of the study confirmed by data collection.
Measured: Day of procedure
Comparison of Procedure Time
Comparison of procedure time, defined as start time to end time in the per protocol population, between the two groups.
Measured: Defined as start time to end time of gastroscopy.
Comparison of Procedure Start Time to Discharge.
Comparison of gastroscopy procedure start time to discharge from endoscopy department post-procedure care time in the per protocol population between the two groups.
Measured: Procedure to discharge
Number of Patients With Adverse Events.
Number of patients reporting adverse events.
Measured: Consent to 72 hours post discharge from the endoscopy unit which is the same day as the procedure.
Comparison of Visual Analogue Scale Scores.
Comparison of VAS (Visual Analogue Scale) scores between the two groups (per protocol). The scale ranges between 0 and 100 where 0 is the worst imaginable experience and 100 being very comfortable. The visual measure is a 100mm line and the score is measured by the participant marking on the line how they felt the procedure was. The research team then measure the line and confirm the score to the nearest mm to get a score of 0-100.
Measured: Completed after procedure completion during the post-procedure care and prior to discharge from the endoscopy unit.
5-point Modified Global Rating Scale Comfort Nurse Score
Percentage of patients with a score of 4 or 5 on the 5-point comfort scale, as measured by the endoscopy nurse, 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. This score is completed by the endoscopy nurse immediately following the patients procedure.
Measured: Completed after procedure completion during the post-procedure care and prior to discharge from the endoscopy unit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201328 Feb 2022

First posted6 Dec 2012 (estimated)
Study startMay 2013
Primary completion28 Feb 2022
Study completion28 Feb 2022

Why it stopped: Resource issues, Poor recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Patients Requiring Diagnostic Gastroscopy With SedationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01744184
Sponsor's protocol ID: ENT1
Status last verified: Sep 2024
First submitted: 4 Dec 2012
Last updated: 12 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-centre, Randomised Controlled Study of Entonox Versus Midazolam Sedation in Gastroscopy.
ClinicalTrials.gov ID: NCT01744184
Acronym / sponsor ID: ENT1
Conditions: Patients Requiring Diagnostic Gastroscopy With Sedation
Keywords: gastroscopy, diagnostic, entonox
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Resource issues, Poor recruitment
Enrolment: 62 participants (actual)
Lead sponsor: The Royal Bournemouth HospitalUniversity, hospital or other
Study start: May 2013 (actual)
Primary completion: 28 Feb 2022 (actual)
Study completion: 28 Feb 2022 (actual)
First posted: 6 Dec 2012 (estimated)
Results: Posted 12 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Midazolam	Active comparator	Drug: Midazolammidazolam 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.
Entonox	Experimental	Drug: EntonoxEntonox 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EntonoxAlso: Oxygen 50.0% +/- 2.0%, Nitrous oxide 50.0% +/- 2.0%Entonox arm	Drug	Entonox
MidazolamAlso: Midazolam 1mg/ml Solution for Injectionup to 5mg midazolam as appropriate	Drug	Midazolam

Primary outcome

Percentage of Patients Mild or no Discomfort During Gastroscopy
Time frame: During gastroscopy procedure
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.

6 secondary outcomes

Number of Participants With Completed Procedures in Both Arms of the Study.
Time frame: Day of procedure
Comparison of Procedure Time
Time frame: Defined as start time to end time of gastroscopy.
Comparison of Procedure Start Time to Discharge.
Time frame: Procedure to discharge
Number of Patients With Adverse Events.
Time frame: Consent to 72 hours post discharge from the endoscopy unit which is the same day as the procedure.
Comparison of Visual Analogue Scale Scores.
Time frame: Completed after procedure completion during the post-procedure care and prior to discharge from the endoscopy unit.
5-point Modified Global Rating Scale Comfort Nurse Score
Time frame: Completed after procedure completion during the post-procedure care and prior to discharge from the endoscopy unit.

Results and safety

Results posted to the registry on 12 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Midazolam	32	31
Entonox	30	29

Primary outcome: Percentage of Patients Mild or no Discomfort During Gastroscopy

Time frame: During gastroscopy procedure. Number. Unit: percentage of participants

Measure	Midazolam n = 32	Entonox n = 30
Value	87.5	63.3

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From participant consent until 72 hours post procedure. Adverse events were monitored while the patient was on site following consent until they were discharged from the endoscopy unit. A follow up phone call was completed 72 hours after the participant was discharged and the participants were asked to recall any adverse events that have occurred since their discharge.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Midazolam	0 of 32 (0%)	1 of 32 (3.1%)	0 of 32
Entonox	0 of 30 (0%)	2 of 30 (6.7%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Simon McLaughlin, MD principal investigator

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Entonox and Midazolam in people with Patients Requiring Diagnostic Gastroscopy With Sedation, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients Mild or no Discomfort During Gastroscopy (time frame: During gastroscopy procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01744184.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.