EndoscopyPhase 4FUSENCT01514695
Fentanyl Use for Sedation in Esophagogastroduodenoscopy
A Phase 4 study testing Midazolam and Fentanyl in people with Endoscopy, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether conscious sedation with a narcotic and sedative (in combination) is as efficacious as a sedative alone for elective upper endoscopy to achieve optimal patient comfort and ease of procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Endoscopy
- What is being tested?
- Midazolam and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- outpatient elective upper endoscopy
- age 18-65
- able to give consent
Who cannot join
- mental incompetency
- pregnancy
- weight <55kg or 110 lbs
- emergent procedures,
- known hypersensitivity or allergy to fentanyl or midazolam
- chronic use of benzodiazepines or opioids
- patients known a priori to require therapeutic interventions in conjunction with their EGD
- patients to have major cardiorespiratory comorbidities, obstructive sleep apnea, liver cirrhosis, or renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fentanyl Use for Sedation in Esophagogastroduodenoscopy (FUSE): a Phase 4, Randomized, Double-blind, Placebo-controlled Trial of Fentanyl Added to Midazolam Compared to Midazolam Alone for Sedation in Routine Upper Endoscopy
The purpose of this study is to determine whether conscious sedation with a narcotic and sedative (in combination) is as efficacious as a sedative alone for elective upper endoscopy to achieve optimal patient comfort and ease of procedure.
Read the detailed description
Upper endoscopy is a valuable procedure that involves a camera advanced from the mouth into the intestines. It is a routine test and considered very safe. However, patients can experience discomfort from air insufflation in the stomach and unpleasantness due to gagging during the procedure. Conscious sedation with medications like sedatives and narcotics are used to improve patient satisfaction and enhance physician ability to perform an optimal examination. The choice of drugs used for sedation in upper endoscopy varies by endoscopist and the goal is always to use the lowest dose possible to achieve the best examination. Combination therapy (with a sedative \& narcotic) may increase the adverse effect profile compared to a sedative alone and not improve the overall experience of the physician or patient. The goal of our study is to assess in randomized, double-blind, placebo controlled study, the effect of using a narcotic (fentanyl) and sedative (midazolam) for sedation compared to a sedative (midazolam) alone.
- Conditions
- Endoscopy
- Keywords
- endoscopy, sedation, opioid, narcotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Starting with 1mg intravenously in all patients. More can be added at the discretion of the physician as needed for sedation.
FentanylDrug
100mcg intravenously given in 2mL syringe at start of procedure
PlaceboOther
One dose of saline (2ml)
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl | Experimental | Fentanyl arm Receives: Drug: Midazolam; Drug: Fentanyl |
| Placebo | Placebo comparator | Placebo of identical appearance Receives: Drug: Midazolam; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with the level of sedation and comfort during the procedure on an analog scale
Level of satisfaction is obtained by telephone the following day, and up to 72 hours after the procedure.
Measured: Within 72 hours of procedure
Secondary outcomes (4)
Physician satisfaction with the level of sedation and ease of procedure based on a visual analog scale
Measured: Following procedure up to time of discharge (average of 45 minutes after procedure started)
Patient willingness to repeat procedure
Measured: Asked within 72 hours of procedure
Presence of significant retching
Recorded by physician completing procedure
Measured: Following procedure up to time of discharge (average of 45 minutes after procedure started)
Presence of adverse events
Any adverse event during procedure up until patient leaves endoscopy unit
Measured: Following procedure up to time of discharge (average of 45 minutes after procedure started)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Khurram Khan, St. Joseph's Healthcare Hamilton
- Investigators
- Khurram J Khan, MD, BSc, MSc, Principal investigator, St Joseph's Healthcare Hamilton, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514695
- Sponsor's protocol ID
- R.P. 11-3611
- Acronym
- FUSE
- Status last verified
- Jan 2013
- First submitted
- 11 Jan 2012
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fentanyl Use for Sedation in Esophagogastroduodenoscopy (FUSE): a Phase 4, Randomized, Double-blind, Placebo-controlled Trial of Fentanyl Added to Midazolam Compared to Midazolam Alone for Sedation in Routine Upper Endoscopy
- ClinicalTrials.gov ID
- NCT01514695
- Acronym / sponsor ID
- FUSE / R.P. 11-3611
- Conditions
- Endoscopy
- Keywords
- endoscopy, sedation, opioid, narcotic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether conscious sedation with a narcotic and sedative (in combination) is as efficacious as a sedative alone for elective upper endoscopy to achieve optimal patient comfort and ease of procedure.
Detailed description
Upper endoscopy is a valuable procedure that involves a camera advanced from the mouth into the intestines. It is a routine test and considered very safe. However, patients can experience discomfort from air insufflation in the stomach and unpleasantness due to gagging during the procedure. Conscious sedation with medications like sedatives and narcotics are used to improve patient satisfaction and enhance physician ability to perform an optimal examination. The choice of drugs used for sedation in upper endoscopy varies by endoscopist and the goal is always to use the lowest dose possible to achieve the best examination. Combination therapy (with a sedative \& narcotic) may increase the adverse effect profile compared to a sedative alone and not improve the overall experience of the physician or patient. The goal of our study is to assess in randomized, double-blind, placebo controlled study, the effect of using a narcotic (fentanyl) and sedative (midazolam) for sedation compared to a sedative (midazolam) alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Experimental | Drug: Midazolam, Drug: FentanylFentanyl arm |
| Placebo | Placebo comparator | Drug: Midazolam, Other: PlaceboPlacebo of identical appearance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- outpatient elective upper endoscopy
- age 18-65
- able to give consent
Key exclusion criteria (8 listed)
- mental incompetency
- pregnancy
- weight <55kg or 110 lbs
- emergent procedures,
- known hypersensitivity or allergy to fentanyl or midazolam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamStarting with 1mg intravenously in all patients. More can be added at the discretion of the physician as needed for sedation. | Drug | Fentanyl, Placebo |
| Fentanyl100mcg intravenously given in 2mL syringe at start of procedure | Drug | Fentanyl |
| PlaceboOne dose of saline (2ml) | Other | Placebo |
Primary outcome
Patient satisfaction with the level of sedation and comfort during the procedure on an analog scale
Time frame: Within 72 hours of procedure
Level of satisfaction is obtained by telephone the following day, and up to 72 hours after the procedure.
4 secondary outcomes
Physician satisfaction with the level of sedation and ease of procedure based on a visual analog scale
Time frame: Following procedure up to time of discharge (average of 45 minutes after procedure started)
Patient willingness to repeat procedure
Time frame: Asked within 72 hours of procedure
Presence of significant retching
Time frame: Following procedure up to time of discharge (average of 45 minutes after procedure started)
Presence of adverse events
Time frame: Following procedure up to time of discharge (average of 45 minutes after procedure started)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khurram J Khan, MD, BSc, MSc principal investigator
St Joseph's Healthcare Hamilton, McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Midazolam and Fentanyl in people with Endoscopy, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction with the level of sedation and comfort during the procedure on an analog scale (time frame: Within 72 hours of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2013.