EmergenciesPhase 4NCT01749579
Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation
A Phase 4 study testing Propofol, Midazolam and Fentanyl in people with Emergencies, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Sixty patients who refer to the emergency ward and need any painful procedure in the ward are randomized into 2 groups. One group is sedated before the procedure using propofol-fentanyl and the other with midazolam-fentanyl, with the same depth of sedation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Emergencies
- What is being tested?
- Propofol, Midazolam and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- May 2012to Feb 2013
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age more than 18
- candidate for a painful procedure
- negative past history of a serious medical condition
- ASA score 0 and 1
Who cannot join
- deep sedation making the patient unable to answer the questions
- pregnancy
- allergy to drugs
- hemodynamic instability
- failure to consent
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Imam Khomeini Hospital
Tehran, Tehran Province
About this study
Official title: Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation in Painful Procedures
Sixty patients who refer to the emergency ward and need any painful procedure in the ward are randomized into 2 groups. One group is sedated before the procedure using propofol-fentanyl and the other with midazolam-fentanyl, with the same depth of sedation. The two groups will be compared regarding recovery time and other parameters described below.
- Conditions
- Emergencies
- Keywords
- propofol, midazolam, duration of recovery, emergency procedure
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol 1 mg/kg bolus then 500 microg/kg every 2 minutes until sedation level equivalent to Ramsey 3
MidazolamDrug
Midazolam 0.03 mg/Kg stat and then the same dose repeated every 2 minutes until a sedation level of Ramsey 3 is achieved.
FentanylDrug
Fentanyl 2 microg/kg intravenous stat and every 2 minutes until the end of procedure
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | The patients will receive propofol for sedation in addition to fentanyl Receives: Drug: Propofol; Drug: Fentanyl |
| Midazolam | Active comparator | The patients will receive midazolam for sedation in addition to fentanyl Receives: Drug: Midazolam; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time
Length of time before complete recovery from sedation is achieved
Measured: Within one hour after sedation
Secondary outcomes (1)
Patients' Pain perception
Pain perception as measured by verbal numeric rating scale
Measured: Within one hour after sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Jalili, MD, Study chair, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749579
- Sponsor's protocol ID
- 130-2640
- Status last verified
- Dec 2012
- First submitted
- 6 Dec 2012
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation in Painful Procedures
- ClinicalTrials.gov ID
- NCT01749579
- Acronym / sponsor ID
- 130-2640
- Conditions
- Emergencies
- Keywords
- propofol, midazolam, duration of recovery, emergency procedure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 13 Dec 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.
Sixty patients who refer to the emergency ward and need any painful procedure in the ward are randomized into 2 groups. One group is sedated before the procedure using propofol-fentanyl and the other with midazolam-fentanyl, with the same depth of sedation. The two groups will be compared regarding recovery time and other parameters described below.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: Propofol, Drug: FentanylThe patients will receive propofol for sedation in addition to fentanyl |
| Midazolam | Active comparator | Drug: Midazolam, Drug: FentanylThe patients will receive midazolam for sedation in addition to fentanyl |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age more than 18
- candidate for a painful procedure
- negative past history of a serious medical condition
- ASA score 0 and 1
Key exclusion criteria (5 listed)
- deep sedation making the patient unable to answer the questions
- pregnancy
- allergy to drugs
- hemodynamic instability
- failure to consent
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 |
|---|---|---|
| PropofolPropofol 1 mg/kg bolus then 500 microg/kg every 2 minutes until sedation level equivalent to Ramsey 3 | Drug | Propofol |
| MidazolamMidazolam 0.03 mg/Kg stat and then the same dose repeated every 2 minutes until a sedation level of Ramsey 3 is achieved. | Drug | Midazolam |
| FentanylFentanyl 2 microg/kg intravenous stat and every 2 minutes until the end of procedure | Drug | Midazolam, Propofol |
Primary outcome
Recovery time
Time frame: Within one hour after sedation
Length of time before complete recovery from sedation is achieved
1 secondary outcome
Patients' Pain perception
Time frame: Within one hour after sedation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2012.
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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.
Mohammad Jalili, MD study chair
Tehran 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 4 study testing Propofol, Midazolam and Fentanyl in people with Emergencies, run by Tehran 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 4 inclusion and 5 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 13 Dec 2012. 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 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 Mohammad Jalili, MD (+98(912)5483998, mjalili@tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery time (time frame: Within one hour after 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 13 Dec 2012.