Patients Requiring Diagnostic Gastroscopy With Sedation
Conditions
Keywords
gastroscopy, diagnostic, entonox
Brief 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.
Interventions
DRUGEntonox
Entonox arm
DRUGMidazolam
up to 5mg midazolam as appropriate
Sponsors
The Royal Bournemouth Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Mild or no Discomfort During Gastroscopy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Procedure Time | Defined as start time to end time of gastroscopy. | Comparison of procedure time, defined as start time to end time in the per protocol population, between the two groups. |
| Comparison of Procedure Start Time to Discharge. | Procedure 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. |
| Number of Participants With Completed Procedures in Both Arms of the Study. | Day of procedure | The percentage of participants with completed procedures in both arms of the study confirmed by data collection. |
| Comparison of Visual Analogue Scale Scores. | Completed after procedure completion during the post-procedure care and prior to discharge from the endoscopy unit. | 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. |
| 5-point Modified Global Rating Scale Comfort Nurse Score | Completed after procedure completion during the post-procedure care and prior to discharge from the endoscopy unit. | 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. |
| Number of Patients With Adverse Events. | Consent to 72 hours post discharge from the endoscopy unit which is the same day as the procedure. | Number of patients reporting adverse events. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Midazolam: up to 5mg midazolam as appropriate | 32 |
| 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.
Entonox: Entonox arm | 30 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Entonox | Total | Midazolam |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 30 participants | 62 participants | 32 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 30 |
| other Total, other adverse events | 1 / 32 | 2 / 30 |
| serious Total, serious adverse events | 0 / 32 | 0 / 30 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Midazolam | Percentage of Patients Mild or no Discomfort During Gastroscopy | 87.5 percentage of participants |
| Entonox | Percentage of Patients Mild or no Discomfort During Gastroscopy | 63.3 percentage of participants |
Secondary
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.
Time frame: Completed after procedure completion during the post-procedure care and prior to discharge from the endoscopy unit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Midazolam | 5-point Modified Global Rating Scale Comfort Nurse Score | 31 Participants |
| Entonox | 5-point Modified Global Rating Scale Comfort Nurse Score | 28 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Midazolam | Comparison of Procedure Start Time to Discharge. | 86 Minutes |
| Entonox | Comparison of Procedure Start Time to Discharge. | 46 Minutes |
Secondary
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Midazolam | Comparison of Procedure Time | 4 Minutes |
| Entonox | Comparison of Procedure Time | 5 Minutes |
Secondary
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.
Population: 1 participant in the Midazolam cohort did not complete the Visual Analogue Scale post procedure prior to discharge.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Midazolam | Comparison of Visual Analogue Scale Scores. | 90 score on a scale |
| Entonox | Comparison of Visual Analogue Scale Scores. | 80 score on a scale |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Midazolam | Number of Participants With Completed Procedures in Both Arms of the Study. | 100 Percentage of participants |
| Entonox | Number of Participants With Completed Procedures in Both Arms of the Study. | 96.7 Percentage of participants |
Secondary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Midazolam | Number of Patients With Adverse Events. | 1 Participants |
| Entonox | Number of Patients With Adverse Events. | 2 Participants |