Preanesthetic MedicationPhase 4NCT03474939
The Effect of Midazolam Premedication on Copeptine Concentration in Blood
A Phase 4 study testing Midazolam Oral Tablet in people with Preanesthetic Medication and Copeptin, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The study aim is to assess whether premedication with midazolam prior to surgery affects copeptin concentration in blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preanesthetic Medication, Copeptin
- What is being tested?
- Midazolam Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 3 Apr 2017to 1 Mar 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective surgery
- Patients with no chronić illness and considered ASA 1 by anesthesiologist
- Patients with mild and controlled chronic illness considered ASA 2 by anesthesiologist
Who cannot join
- Patient refusal
- Chronic illness requiring intense treatment or uncontrolled illness (ASA 3 or more)
Trial locations and contacts
1 site in 1 country.
Poland1 site
I Department of Anesthesiology and Intensive Care Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-005
About this study
The study aim is to assess whether premedication with midazolam prior to surgery affects copeptin concentration in blood.
- Conditions
- Preanesthetic Medication, Copeptin
- Being tested
- Midazolam Oral Tablet, Placebo Oral Tablet
- Medical subject headings
- Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam Oral TabletDrug
Midazolam Oral tablet
Placebo Oral TabletOther
Glucose 1000mg tablet night before surgery and 60 minutes before surgery
| Study group | Role | What they receive |
|---|---|---|
| MIDAZOLAM | Active comparator | Patients receive midazolam 7,5mg night before and 60 minutes prior to surgery as part of preanesthetic medication Receives: Drug: Midazolam Oral Tablet |
| PLACEBO | Placebo comparator | Patients receive 1000mg Glucose tablets night before and 60 minutes prior to surgery during premedication Receives: Other: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in copeptin concentration
Change in the concentration of copeptine measured in blood serum
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start3 Apr 2017
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preanesthetic MedicationStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marek Janiak, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474939
- Sponsor's protocol ID
- MIDPRECOP
- Status last verified
- Apr 2019
- First submitted
- 16 Mar 2018
- Last updated
- 19 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Midazolam Premedication on Copeptine Concentration in Blood
- ClinicalTrials.gov ID
- NCT03474939
- Acronym / sponsor ID
- MIDPRECOP
- Conditions
- Preanesthetic Medication, Copeptin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 23 Mar 2018 (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.
The study aim is to assess whether premedication with midazolam prior to surgery affects copeptin concentration in blood.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIDAZOLAM | Active comparator | Drug: Midazolam Oral TabletPatients receive midazolam 7,5mg night before and 60 minutes prior to surgery as part of preanesthetic medication |
| PLACEBO | Placebo comparator | Other: Placebo Oral TabletPatients receive 1000mg Glucose tablets night before and 60 minutes prior to surgery during premedication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective surgery
- Patients with no chronić illness and considered ASA 1 by anesthesiologist
- Patients with mild and controlled chronic illness considered ASA 2 by anesthesiologist
Key exclusion criteria (2 listed)
- Patient refusal
- Chronic illness requiring intense treatment or uncontrolled illness (ASA 3 or more)
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 Oral TabletMidazolam Oral tablet | Drug | MIDAZOLAM |
| Placebo Oral TabletGlucose 1000mg tablet night before surgery and 60 minutes before surgery | Other | PLACEBO |
Primary outcome
Change in copeptin concentration
Time frame: 48 hours
Change in the concentration of copeptine measured in blood serum
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 19 Apr 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Oral Tablet in people with Preanesthetic Medication and Copeptin, run by Medical University of Warsaw at 1 site in Poland.
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 2 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 19 Apr 2019. 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 Poland. 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?
Change in copeptin concentration (time frame: 48 hours). 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 19 Apr 2019.