Conscious Sedation Failure During ProcedurePhase 4NCT01990937
Oral Midazolam for Sedation in Esophagogastroduodenoscopy(EGD)
A Phase 4 study testing Oral midazolam in people with Conscious Sedation Failure During Procedure, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial summary
Can oral midazolam used for sedation in patients undergoing upper gastrointestinal endoscopy ? Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Conscious Sedation Failure During Procedure
- What is being tested?
- Oral midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2013to Feb 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo elective diagnostic EGD
- American Society of Anesthesia (ASA) criteria to be class 1 to 2
Who cannot join
- History of gastrectomy, esophagectomy, pancreaticoduodenectomy, or other operation on the upper-GI tract
- American Society of Anesthesia (ASA) criteria to be class 3 to 4
- Pregnancy
- Alcoholism
- Drug abuse
- Taking psychotic medications
- Allergy to midazolam.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Division of Gastroenterology, Department of Medicine, Phramongkutklao hospital
Bangkok, 10400
Chaipichit Puttapitakpong, Doctor, 6681707-3005, iamkeang@hotmail.com
Chaipichit Puttapitakpong, Doctor
About this study
Official title: Effectiveness of Oral Midazolam for Sedation in Patients Undergoing Upper Gastrointestinal Endoscopy
Can oral midazolam used for sedation in patients undergoing upper gastrointestinal endoscopy ?
Read the detailed description
Five mg of midazolam was intake orally about 30 minutes before undergoing perform upper gastrointestinal endoscopy. Declined of anxiety scores was primary end point.
- Being tested
- Oral midazolam
- Keywords
- oral midazolam, sedation, premedication, upper gastrointestinal endoscopy, EGD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral midazolamDrug
Also called Dormicum
5 mg in 15 mL of apple juice, orally 30 minutes before undergoing EGD
| Study group | Role | What they receive |
|---|---|---|
| Oral midazolam | Active comparator | Oral midazolam (5 mg) in 15 mL of apple juice was drunk 30 minutes before EGD Receives: Drug: Oral midazolam |
| Apple juice | Placebo comparator | 15 mL of apple juice was drunk 30 minutes before EGD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of Anxiety score
- Anxiety score is 10-cm scaled visual analog scale.
- Anxiety score which asked the patient 5 minutes before EGD, called "Pre EGD anxiety score"
- Anxiety score which asked the patient after fully recovery, called "During EGD anxiety score".
- Difference of anxiety score means "Pre EGD minus During anxiety score".
- Fully recovery means fully gain of consiouness (time, place, person).
Measured: Asked the patient 5 minutes before EGD and then after fully recovery from sedation.
Secondary outcomes (1)
Overall tolerance
Fully recovery means fully gain of consiouness (time, place, person).
Overall tolerance was grading into 4 levels;
- Poor : Very uncomfortable during the entire procedure
- Fair : Uncomfortable during most of the procedure
- Good : Believes the procedure was generally comfortable, there were portions of procedure during which sedation could have been given
- Excellent : Believes the procedure was comfortable, no additional sedation was needed
Measured: Asked the patient after fully recovery from sedation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conscious Sedation Failure During ProcedureStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chaipichit Puttapitakpong, Doctor, Principal investigator, Division of gastroentrology, Department of Medicine, Phramongkutklao hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990937
- Sponsor's protocol ID
- PMK-031
- Status last verified
- Oct 2014
- First submitted
- 20 Oct 2013
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Oral Midazolam for Sedation in Patients Undergoing Upper Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT01990937
- Acronym / sponsor ID
- PMK-031
- Keywords
- oral midazolam, sedation, premedication, upper gastrointestinal endoscopy, EGD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 25 Nov 2013 (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.
Can oral midazolam used for sedation in patients undergoing upper gastrointestinal endoscopy ?
Detailed description
Five mg of midazolam was intake orally about 30 minutes before undergoing perform upper gastrointestinal endoscopy. Declined of anxiety scores was primary end point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral midazolam | Active comparator | Drug: Oral midazolamOral midazolam (5 mg) in 15 mL of apple juice was drunk 30 minutes before EGD |
| Apple juice | Placebo comparator | –15 mL of apple juice was drunk 30 minutes before EGD |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled to undergo elective diagnostic EGD
- American Society of Anesthesia (ASA) criteria to be class 1 to 2
Key exclusion criteria (7 listed)
- History of gastrectomy, esophagectomy, pancreaticoduodenectomy, or other operation on the upper-GI tract
- American Society of Anesthesia (ASA) criteria to be class 3 to 4
- Pregnancy
- Alcoholism
- Drug abuse
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 |
|---|---|---|
| Oral midazolamAlso: Dormicum5 mg in 15 mL of apple juice, orally 30 minutes before undergoing EGD | Drug | Oral midazolam |
Primary outcome
Difference of Anxiety score
Time frame: Asked the patient 5 minutes before EGD and then after fully recovery from sedation.
* Anxiety score is 10-cm scaled visual analog scale. * Anxiety score which asked the patient 5 minutes before EGD, called "Pre EGD anxiety score" * Anxiety score which asked the patient after fully recovery, called "During EGD anxiety score". * Difference of anxiety score means "Pre EGD minus During anxiety score". * Fully recovery means fully gain of consiouness (time, place, person).
1 secondary outcome
Overall tolerance
Time frame: Asked the patient after fully recovery from sedation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
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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.
Chaipichit Puttapitakpong, Doctor principal investigator
Division of gastroentrology, Department of Medicine, Phramongkutklao hospital
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 Oral midazolam in people with Conscious Sedation Failure During Procedure, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
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 2 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: status not confirmed, as of the sponsor's last update on 29 Oct 2014. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chaipichit Puttapitakpong, Doctor (6681707-3005, iamkeang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of Anxiety score (time frame: Asked the patient 5 minutes before EGD and then after fully recovery from sedation.). 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 29 Oct 2014.