Diagnostic EsophagogastroduodenoscopyPhase 2/3NCT03130842
Premedication With Alprazolam and Midazolam for Upper Gastrointestinal Endoscopy
A Phase 2/3 study testing Sublingual alprazolam and Oral midazolam in people with Diagnostic Esophagogastroduodenoscopy, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
Diagnostic upper GI endoscopy can be uncomfortable and stressful for many patients. Various methods are available for sedation during this procedure. Because of some side effects related to intravenous administration of sedatives, oral administration of these drugs is under attention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diagnostic Esophagogastroduodenoscopy
- What is being tested?
- Sublingual alprazolam and Oral midazolam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteIran
- Study dates
- 17 Sep 2016to 15 Feb 2017
- Phase
- Phase 2/3
- 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
- Referring for upper GI endoscopy
- Age 18 to 65 years
- First experience of upper GI endoscopy
- Class I or II of American Anesthesiology Association
- Willingness to participate
Who cannot join
- Severe psychiatric, neurological, cardio-vascular, or renal disorders
- History of allergy or intolerance to benzodiazepines or lidocaine
- History of upper GI surgery
- Pregnancy or lactation
- GI anomalia during endoscopy
- Need for therapeutic procedures during endoscopy
- Active bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Efficacy of Oral Midazolam and Sublingual Alprazolam in Reducing Anxiety and Pain/Discomfort Related to Diagnostic Upper Gastrointestinal Endoscopy in Adults
Diagnostic upper GI endoscopy can be uncomfortable and stressful for many patients. Various methods are available for sedation during this procedure. Because of some side effects related to intravenous administration of sedatives, oral administration of these drugs is under attention. Alprazolam is a benzodiazepine which is used mainly in treatment of anxiety. Intravenous midazolam is being used by some centers for sedation during endoscopy, but the oral form can also be used with probably same efficacy. Hence, investigators compare the efficacy/safety of oral midazolam and sublingual alprazolam as for sedation during this procedure. Investigators hypothesize that sublingual alprazolam is as effective as oral midazolam in reducing anxiety and pain/discomfort related to the procedure.
- Conditions
- Diagnostic Esophagogastroduodenoscopy
- Being tested
- Sublingual alprazolam, Oral midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual alprazolamDrug
Patients receive one dose of oral formulation of alprazolam 0.5 mg for sublingual-administered at least 30 minutes before the procedure.
Oral midazolamDrug
Patients receive one dose of intravenous formulation of alprazolam 7.5 mg for oral-administered (in syrup with apple juice) at least 30 minutes before the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Sublingual alprazolam | Active comparator | Not described Receives: Drug: Sublingual alprazolam |
| Oral midazolam | Active comparator | Not described Receives: Drug: Oral midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake
Procedure related discomfort is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake.
Measured: 5 minutes after the procedure
Change in anxiety
Procedure related anxiety is assessed by patients on a 11-point numeric rating scales at baseline and then at 30 minutes after the medication.
Measured: At baseline and at 30 minutes after medication
Secondary outcomes (6)
Satisfaction is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake.
Procedure related satisfaction is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake.
Measured: 5 minutes after the procedure
Tolerance is assessed by patients from no compliance (0) to excellent compliance (4) about 5 minutes after the procedure when patients are fully awake.
Tolerance is assessed by patients from no compliance (0) to excellent compliance (4) about 5 minutes after the procedure when patients are fully awake.
Measured: 5 minutes after the procedure
Duration of the procedure
Duration of the procedure is defined as time (minute) from endoscope insertion to endoscope removal.
Measured: From endoscope insertion to endoscope removal
Hypotension
Blood pressure is monitored from baseline to 30 minutes after beginning of the procedure, with 5 minutes intervals. Hypotension episode is defined as systolic blood pressure of < 90 mm Hg
Measured: At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
Bradycardia
Heart rate is monitored from baseline to 30 minutes after beginning of the procedure, with 5 minutes intervals. Bradycardia episode is defined as heart rate of < 60 bpm.
Measured: At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
Desaturation
Arterial O2 saturation is monitored from baseline to 30 minutes after beginning of the procedure, with 5 minutes intervals. Desaturation episode is defined as as arterial oxygen saturation of < 90%.
Measured: At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start17 Sep 2016
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diagnostic EsophagogastroduodenoscopyStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elham Tabesh, Isfahan University of Medical Sciences
- Investigators
- Vahid Sebghatolahi, MD, Study director, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130842
- Sponsor's protocol ID
- 395569
- Status last verified
- Apr 2017
- First submitted
- 3 Apr 2017
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be available based on the IUMS policy
Publications
Shavakhi A, Soleiman S, Gholamrezaei A, Khodadoostan M, Shavakhi S, Tahery A, Minakari M. Premedication with sublingual or oral alprazolam in adults undergoing diagnostic upper gastrointestinal endoscopy. Endoscopy. 2014 Aug;46(8):633-9. doi: 10.1055/s-0034-1377305. Epub 2014 Jun 30.
PubMed 24977401
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Efficacy of Oral Midazolam and Sublingual Alprazolam in Reducing Anxiety and Pain/Discomfort Related to Diagnostic Upper Gastrointestinal Endoscopy in Adults
- ClinicalTrials.gov ID
- NCT03130842
- Acronym / sponsor ID
- 395569
- Conditions
- Diagnostic Esophagogastroduodenoscopy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 17 Sep 2016 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 27 Apr 2017 (actual)
- 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.
Diagnostic upper GI endoscopy can be uncomfortable and stressful for many patients. Various methods are available for sedation during this procedure. Because of some side effects related to intravenous administration of sedatives, oral administration of these drugs is under attention. Alprazolam is a benzodiazepine which is used mainly in treatment of anxiety. Intravenous midazolam is being used by some centers for sedation during endoscopy, but the oral form can also be used with probably same efficacy. Hence, investigators compare the efficacy/safety of oral midazolam and sublingual alprazolam as for sedation during this procedure. Investigators hypothesize that sublingual alprazolam is as effective as oral midazolam in reducing anxiety and pain/discomfort related to the procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublingual alprazolam | Active comparator | Drug: Sublingual alprazolam |
| Oral midazolam | Active comparator | Drug: Oral midazolam |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Referring for upper GI endoscopy
- Age 18 to 65 years
- First experience of upper GI endoscopy
- Class I or II of American Anesthesiology Association
- Willingness to participate
Key exclusion criteria (7 listed)
- Severe psychiatric, neurological, cardio-vascular, or renal disorders
- History of allergy or intolerance to benzodiazepines or lidocaine
- History of upper GI surgery
- Pregnancy or lactation
- GI anomalia during endoscopy
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 |
|---|---|---|
| Sublingual alprazolamPatients receive one dose of oral formulation of alprazolam 0.5 mg for sublingual-administered at least 30 minutes before the procedure. | Drug | Sublingual alprazolam |
| Oral midazolamPatients receive one dose of intravenous formulation of alprazolam 7.5 mg for oral-administered (in syrup with apple juice) at least 30 minutes before the procedure. | Drug | Oral midazolam |
Primary outcome
Discomfort assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake
Time frame: 5 minutes after the procedure
Procedure related discomfort is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake.
Change in anxiety
Time frame: At baseline and at 30 minutes after medication
Procedure related anxiety is assessed by patients on a 11-point numeric rating scales at baseline and then at 30 minutes after the medication.
6 secondary outcomes
Satisfaction is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake.
Time frame: 5 minutes after the procedure
Tolerance is assessed by patients from no compliance (0) to excellent compliance (4) about 5 minutes after the procedure when patients are fully awake.
Time frame: 5 minutes after the procedure
Duration of the procedure
Time frame: From endoscope insertion to endoscope removal
Hypotension
Time frame: At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
Bradycardia
Time frame: At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
Desaturation
Time frame: At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
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 27 Apr 2017.
- Background: PubMed 24977401Shavakhi A, Soleiman S, Gholamrezaei A, Khodadoostan M, Shavakhi S, Tahery A, Minakari M. Premedication with sublingual or oral alprazolam in adults undergoing diagnostic upper gastrointestinal endoscopy. Endoscopy. 2014 Aug;46(8):633-9. doi: 10.1055/s-0034-1377305. Epub 2014 Jun 30.
- Individual participant dataSharing planned: Undecided. Data may be available based on the IUMS policy
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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.
Vahid Sebghatolahi, MD study director
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sublingual alprazolam and Oral midazolam in people with Diagnostic Esophagogastroduodenoscopy, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 5 inclusion and 7 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 27 Apr 2017. 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 Iran. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Discomfort assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake (time frame: 5 minutes after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03130842, which also lists 1 linked publication.
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 27 Apr 2017.