NCT01744184|TerminatedPhase 4ResultsDMC
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Resource issues, Poor recruitment
A Single-centre, Randomised Controlled Study of Entonox Versus Midazolam Sedation in Gastroscopy.
Sponsor study identifier
interventional
62
1 country
1
Study Start
May 2013
Actual (reported)Primary Completion
February 28, 2022
Actual (reported)Study Completion
February 28, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 4, 2012
Actual (reported)December 6, 2012
Actual (reported)May 2013
Actual (reported)February 28, 2022
Actual (reported)February 28, 2022
Actual (reported)November 12, 2024
Actual (reported)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
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.
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.
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.
Entonox arm
up to 5mg midazolam as appropriate
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth, Dorset, BH7 7DW, United Kingdom
Simon McLaughlin, MD
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
62 participants (actual enrollment reported by the registry).
First Submitted
December 4, 2012
First Posted
December 6, 2012
Study Start
May 2013
Actual (reported)Primary Completion
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
February 28, 2022
Actual (reported)Study Completion
February 28, 2022
Actual (reported)Last Updated
November 12, 2024
Results First Posted
November 12, 2024
Record last verified: 2024-09
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Source: ClinicalTrials.gov.
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