Gastro-Esophageal Reflux Disease With UlcerationNCT03813043
The 90% Effective Sedation Dose Of Midazolam
A study testing Midazolam injection in people with Gastro-Esophageal Reflux Disease With Ulceration, run by King Fahad Specialist Hospital Dammam.
Trial summary
There are no clear conclusive clinical reports defining the adequate effective dose of midazolam in patients undergoing day-case esophageal-gastro-duodenoscopy (EGD). Defining such dosage will facilitate practitioners who are not anesthesia professionals to administer sedative drugs to establish a satisfactory level… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Gastro-Esophageal Reflux Disease With Ulceration
- What is being tested?
- Midazolam injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2019to 15 Dec 2019
- Phase
- Interventional
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA 1\&2
Who cannot join
- Patients with hypersensitivity to midazolam,
- Age less than 18,
- Obstructive sleep apnea
- known or suspected memory impairment,
- Patients with psychiatric disorders,
- visual or hearing impairment and pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Determination Of The 90% Effective Sedation Dose Of Midazolam In Patients Undergoing Diagnostic Upper Gastric-Endoscopy
There are no clear conclusive clinical reports defining the adequate effective dose of midazolam in patients undergoing day-case esophageal-gastro-duodenoscopy (EGD). Defining such dosage will facilitate practitioners who are not anesthesia professionals to administer sedative drugs to establish a satisfactory level of moderate sedation. Our first aim is to determine the effective dose for 90% of patients (ED 90) of midazolam undergoing day-case EGD.
Read the detailed description
Midazolam is widely used in conscious sedation during esophageal-gastro-duodenoscopy (EGD) to increase patient's tolerance and cooperation. Its short duration, cardiorespiratory stability, anxiolytic and amnestic properties makes it the drug of choice for moderate sedation in day case short procedure 1. Therefore, moderate sedation during digestive endoscopy can be administered by endoscopist in safe monitored area while a qualified nurse monitors the level of consciousness and vital sings. The endoscopist's privileges to administer deeper alternative drug, i.e. propofol, might not be provided easily in many centers especially outside the hospital due to certain limitations. However, the patient's and endoscopist's satisfaction might not be achieved easily with the administration of midazolam for moderate sedation. Inappropriate dose will fail to produce amnesia or may cause respiratory side effect and delayed recovery and discharge. Therefore, there are no clear conclusive clinical reports defining the adequate effective dose of midazolam in patients undergoing day case EGD. This is obvious from different dosage used in various studies. In addition, midazolam dosage in adult is rarely based on the body weight during our daily clinical practice. Defining such dosage will facilitate practitioners who are not anesthesia professionals to administer sedative drugs to establish satisfactory level of moderate sedation. Our first aim is to determine the effective dose for 90% of patients (ED 90) of midazolam undergoing day case EGD.
- Being tested
- Midazolam injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam injectionDrug
Also called Dormicum
Midazolam 2mg iv to be used as starting dose using Biased coins up and down method (BCM)
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Other | Midazolam 2 mg as started dosage will be used for first patients and for the other patients will receive an predetermined dosage accordingly Receives: Drug: Midazolam injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defining the ED90% of Midazolam for sedation of EGD
Calculating the effective Midazolam sedative dosage in 90% of patients undergoing EGD
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start15 Feb 2019 (estimated)
- Primary completion15 Nov 2019 (estimated)
- Study completion15 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-Esophageal Reflux Disease With UlcerationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Searching the ED90% of Midazolam using Biased coins method in 40 patients undergoing EGD
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Fahad Specialist Hospital Dammam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Munir Bamadhaj, King Fahad Specialist Hospital Dammam
- Investigators
- Ahed zeidan, MD, Study director, King Fahad Specialist Hospital Dammam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813043
- Sponsor's protocol ID
- ANS0307
- Status last verified
- Jan 2019
- First submitted
- 18 Jan 2019
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be collected inside the electronic system with limited access
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination Of The 90% Effective Sedation Dose Of Midazolam In Patients Undergoing Diagnostic Upper Gastric-Endoscopy
- ClinicalTrials.gov ID
- NCT03813043
- Acronym / sponsor ID
- ANS0307
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- King Fahad Specialist Hospital DammamUniversity, hospital or other
- Study start
- 15 Feb 2019 (estimated)
- Primary completion
- 15 Nov 2019 (estimated)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 23 Jan 2019 (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.
There are no clear conclusive clinical reports defining the adequate effective dose of midazolam in patients undergoing day-case esophageal-gastro-duodenoscopy (EGD). Defining such dosage will facilitate practitioners who are not anesthesia professionals to administer sedative drugs to establish a satisfactory level of moderate sedation. Our first aim is to determine the effective dose for 90% of patients (ED 90) of midazolam undergoing day-case EGD.
Detailed description
Midazolam is widely used in conscious sedation during esophageal-gastro-duodenoscopy (EGD) to increase patient's tolerance and cooperation. Its short duration, cardiorespiratory stability, anxiolytic and amnestic properties makes it the drug of choice for moderate sedation in day case short procedure 1. Therefore, moderate sedation during digestive endoscopy can be administered by endoscopist in safe monitored area while a qualified nurse monitors the level of consciousness and vital sings. The endoscopist's privileges to administer deeper alternative drug, i.e. propofol, might not be provided easily in many centers especially outside the hospital due to certain limitations. However, the patient's and endoscopist's satisfaction might not be achieved easily with the administration of midazolam for moderate sedation. Inappropriate dose will fail to produce amnesia or may cause respiratory side effect and delayed recovery and discharge. Therefore, there are no clear conclusive clinical reports defining the adequate effective dose of midazolam in patients undergoing day case EGD. This is obvious from different dosage used in various studies. In addition, midazolam dosage in adult is rarely based on the body weight during our daily clinical practice. Defining such dosage will facilitate practitioners who are not anesthesia professionals to administer sedative drugs to establish satisfactory level of moderate sedation. Our first aim is to determine the effective dose for 90% of patients (ED 90) of midazolam undergoing day case EGD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Searching the ED90% of Midazolam using Biased coins method in 40 patients undergoing EGD
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Other | Drug: Midazolam injectionMidazolam 2 mg as started dosage will be used for first patients and for the other patients will receive an predetermined dosage accordingly |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA 1\&2
Key exclusion criteria (6 listed)
- Patients with hypersensitivity to midazolam,
- Age less than 18,
- Obstructive sleep apnea
- known or suspected memory impairment,
- Patients with psychiatric disorders,
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 |
|---|---|---|
| Midazolam injectionAlso: DormicumMidazolam 2mg iv to be used as starting dose using Biased coins up and down method (BCM) | Drug | Midazolam |
Primary outcome
Defining the ED90% of Midazolam for sedation of EGD
Time frame: 10 months
Calculating the effective Midazolam sedative dosage in 90% of patients undergoing EGD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Individual participant dataSharing planned: Undecided. Data will be collected inside the electronic system with limited access
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.
Ahed zeidan, MD study director
King Fahad Specialist Hospital Dammam
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam injection in people with Gastro-Esophageal Reflux Disease With Ulceration, run by King Fahad Specialist Hospital Dammam.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact IRB IRB (+96613 844 2222 ext. 7093, irb@kfsh.med.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defining the ED90% of Midazolam for sedation of EGD (time frame: 10 months). 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 23 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.