SedationPhase 4NCT00997126

Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation

A Phase 4 study testing Propofol and Alfentanil in people with Sedation, run by Hennepin Healthcare Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a clinical trial of propofol and alfentanil as agents for moderated procedural sedation in patients undergoing sedation in the emergency department (ED). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sedation
What is being tested?: Propofol and Alfentanil
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Apr 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Adults undergoing moderate procedural sedation in the Emergency Department

Who cannot join

Age <18 years
Pregnancy
Intoxication
Cannot give informed consent
Allergy to any of the three study medications
ASA physical status score > 2
Patients who require deep procedural sedation

Trial locations and contacts

1 site in 1 country.

United States1 site

Hennepin County Medical Center
Minneapolis, Minnesota, 55415

Other trials in United States

About this study

Official title: Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation in the Emergency Department

This is a clinical trial of propofol and alfentanil as agents for moderated procedural sedation in patients undergoing sedation in the emergency department (ED).

Read the detailed description

This was initially going to be a trial of propofol vs alfentanil vs nitrous oxide, but our use of nitrous oxide was discontinued before the trial began and the trial was conducted with only two arms

Conditions: Sedation
Being tested: Propofol, Alfentanil
Keywords: propofol, alfentanil, nitrous oxide, moderate procedural sedation, Moderate Procedural Sedation in the Emergency Department

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PropofolDrug
Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation
AlfentanilDrug
Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation

Study groups in NCT00997126
Study group	Role	What they receive
Propofol	Active comparator	Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation Receives: Drug: Propofol
Alfentanil	Active comparator	Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation Receives: Drug: Alfentanil

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure
Measured: From one minute prior to start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure (~3-60 minutes depending on procedure duration)

Secondary outcomes (4)

Time to Return of Baseline Mental Status From Start of Procedure in Minutes
Measured: Single time point after completion of sedation procedure, measured from start of procedure until the patient returns to baseline mental status up to 24 hours
Depth of Sedation Measured Using the OAAS Scale
Observers Assesment of Alertness Scale, 5 responds normally to voice, 4 lethargic response to voice, 3 responds only to loud voice or light touch, 2 responds only to mild prodding or shaking, 1 responds only to painful stimuli, 0 no response to painful stimuli
Measured: Single measurement during sedation procedure
Patient Reported Pain
Measured: Single measurement immediately after patient returns to baseline mental status after sedation procedure
Patient Reported Recall of the Procedure
Measured: Single measurement immediately after patient returns to baseline mental status after sedation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Apr 2015

First posted19 Oct 2009 (estimated)
Study startOct 2009
Primary completionApr 2015
Study completionApr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SedationStudies 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: None (open label)
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00997126
Sponsor's protocol ID: MMRF093030
Status last verified: Dec 2016
First submitted: 12 Oct 2009
Last updated: 27 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sedation trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation in the Emergency Department
ClinicalTrials.gov ID: NCT00997126
Acronym / sponsor ID: MMRF093030
Conditions: Sedation
Keywords: propofol, alfentanil, nitrous oxide, moderate procedural sedation, Moderate Procedural Sedation in the Emergency Department
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Hennepin Healthcare Research InstituteUniversity, hospital or other
Study start: Oct 2009
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 19 Oct 2009 (estimated)
Results: Posted 27 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a clinical trial of propofol and alfentanil as agents for moderated procedural sedation in patients undergoing sedation in the emergency department (ED).

Detailed description

This was initially going to be a trial of propofol vs alfentanil vs nitrous oxide, but our use of nitrous oxide was discontinued before the trial began and the trial was conducted with only two arms

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Propofol	Active comparator	Drug: PropofolPropofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation
Alfentanil	Active comparator	Drug: AlfentanilSedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adults undergoing moderate procedural sedation in the Emergency Department

Key exclusion criteria (7 listed)

Age <18 years
Pregnancy
Intoxication
Cannot give informed consent
Allergy to any of the three study medications

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 IV followed by 0.5 mg/kg prn sedation	Drug	Propofol
AlfentanilAlfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation	Drug	Alfentanil

Primary outcome

Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure
Time frame: From one minute prior to start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure (~3-60 minutes depending on procedure duration)

4 secondary outcomes

Time to Return of Baseline Mental Status From Start of Procedure in Minutes
Time frame: Single time point after completion of sedation procedure, measured from start of procedure until the patient returns to baseline mental status up to 24 hours
Depth of Sedation Measured Using the OAAS Scale
Time frame: Single measurement during sedation procedure
Patient Reported Pain
Time frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure
Patient Reported Recall of the Procedure
Time frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure

Results and safety

Results posted to the registry on 27 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Propofol	63	56
Alfentanil	63	52

Primary outcome: Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure

Time frame: From one minute prior to start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure (~3-60 minutes depending on procedure duration). Number. Unit: participants

Measure	Propofol n = 56	Alfentanil n = 52
Value	11	12

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From 1 minute prior to the procedure until the patient returned to baseline mental status. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Propofol	0 of 56 (0%)	25 of 56 (44.6%)	Not reported
Alfentanil	0 of 52 (0%)	29 of 52 (55.8%)	Not reported

Limitations and caveats (from the sponsor): our capability of administering nitrous oxide was diminished as the trial was started, and the trial was conducted using on the propofol and alfentanil arms.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

James R Miner, MD principal investigator

Hennepin Healthcare Research Institute

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 and Alfentanil in people with Sedation, run by Hennepin Healthcare Research Institute at 1 site in United States.

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 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 Jan 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 United States. 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?

Yes. Results are posted in the registry (first posted 27 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure (time frame: From one minute prior to start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure (~3-60 minutes depending on procedure duration)). 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 NCT00997126.

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 Jan 2017.