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

Phase 4TerminatedNCT01744184

The Royal Bournemouth Hospital62 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Patients Requiring Diagnostic Gastroscopy With Sedation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: During gastroscopy procedure

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Procedure to discharge

Number of Patients With Adverse Events.

Number of patients reporting 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.

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.

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

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.