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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2022-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Patients Requiring Diagnostic Gastroscopy With Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

up to 5mg midazolam as appropriate

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.

Group Type EXPERIMENTAL

Entonox

Intervention Type DRUG

Entonox arm

Interventions

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Entonox

Entonox arm

Intervention Type DRUG

Midazolam

up to 5mg midazolam as appropriate

Intervention Type DRUG

Other Intervention Names

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Oxygen 50.0% +/- 2.0% Nitrous oxide 50.0% +/- 2.0% Midazolam 1mg/ml Solution for Injection

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No