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

NCT01744184 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-11-12

Study results available
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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

Interventions

DRUG

Entonox

Entonox arm

DRUG

Midazolam

up to 5mg midazolam as appropriate

Sponsors & Collaborators

  • The Royal Bournemouth Hospital

    lead OTHER

Principal Investigators

  • Simon McLaughlin, MD · The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01744184 on ClinicalTrials.gov