SedationPhase 4NCT00997113

Stress During Deep Sedation With Propofol With and Without Alfentanil

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 randomized clinical trial of deep procedural sedation with propofol with and without supplemental alfentanil. Patients will be assessed for total and fractionated serum catecholamines before and after the procedure in addition to usual procedural sedation outcomes parameters to assess the adrenergic effect… 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: 20 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Dec 2012
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

patients who will require deep procedural sedation with propofol in the ED

Who cannot join

age <18
intoxication
unable to provide informed consent
allergy to propofol or alfentanil
pregnant
ASA physical status score > 2

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: Physiologic Stress During Procedural Sedation With and Without Alfentanil

Conditions: Sedation
Being tested: propofol, alfentanil
Keywords: propofol, alfentanil, procedural sedation, stress biomarkers, Deep procedural sedation in the ED

What participants receive

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

propofolDrug
1 mg/kg IV followed by 0.5 mg/kg iv prn sedation
alfentanilDrug
alfentanil 10 ug/kg immediately prior to propofol dose

Study groups in NCT00997113
Study group	Role	What they receive
Propofol	Active comparator	propofol only for deep procedural sedation Receives: Drug: propofol
Propofol/alfentanil	Active comparator	Propofol with alfentanil for deep procedural sedation Receives: Drug: propofol; Drug: alfentanil

What is being measured

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

Change in Serum Catecholamines
change in serum catecholamine levels, values indicate a decrease over the procedure. These patients underwent fracture reduction procedures which are typically associated with an increase in catecholamines.
Measured: one minute prior to the start of the procedure and immediately at the end of sedation procedure (median time of procedure 12 minutes range 6-26 minutes

Secondary outcomes (2)

Respiratory Depression
categorized as a change in end tidal CO2 from baseline >10mmhg, a loss of end tidal CO2 waveform for more than 6 seconds, or an oxygen saturation less than 93%.
Measured: From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status
Patient Reported Pain and Recall of the Painful Procedure for Which They Were Sedated Measure by Patient Query After They Had Regained Their Baseline Level of Consciousness After the Procedure
Pain and recall were measured seperately by direct patient query. The patient was asked if they experienced any pain during the procedure. The patient was then asked if they could recall any part of the fracture reduction. Patients who had either pain with the procedure of recall of the procedure were counted as having pain or recall with the procedure.
Measured: single time point measured after sedation procedure completed

Timeline

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

Oct 2009Dec 2012

First posted19 Oct 2009 (estimated)
Study startOct 2009
Primary completionOct 2012
Study completionDec 2012

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.
Publications (1)Papers the sponsor has linked to this study.
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: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00997113
Sponsor's protocol ID: MMRF093051
Status last verified: Sep 2014
First submitted: 12 Oct 2009
Last updated: 25 Sep 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Miner JR, Moore JC, Plummer D, Gray RO, Patel S, Ho JD. Randomized clinical trial of the effect of supplemental opioids in procedural sedation with propofol on serum catecholamines. Acad Emerg Med. 2013 Apr;20(4):330-7. doi: 10.1111/acem.12110.
PubMed 23701339

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 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physiologic Stress During Procedural Sedation With and Without Alfentanil
ClinicalTrials.gov ID: NCT00997113
Acronym / sponsor ID: MMRF093051
Conditions: Sedation
Keywords: propofol, alfentanil, procedural sedation, stress biomarkers, Deep procedural sedation in the ED
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Hennepin Healthcare Research InstituteUniversity, hospital or other
Study start: Oct 2009
Primary completion: Oct 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 19 Oct 2009 (estimated)
Results: Posted 25 Sep 2014

Clinical summary

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

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 only for deep procedural sedation
Propofol/alfentanil	Active comparator	Drug: propofol, Drug: alfentanilPropofol with alfentanil for deep procedural 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)

patients who will require deep procedural sedation with propofol in the ED

Key exclusion criteria (6 listed)

age <18
intoxication
unable to provide informed consent
allergy to propofol or alfentanil
pregnant

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
propofol1 mg/kg IV followed by 0.5 mg/kg iv prn sedation	Drug	Propofol, Propofol/alfentanil
alfentanilalfentanil 10 ug/kg immediately prior to propofol dose	Drug	Propofol/alfentanil

Primary outcome

Change in Serum Catecholamines
Time frame: one minute prior to the start of the procedure and immediately at the end of sedation procedure (median time of procedure 12 minutes range 6-26 minutes
change in serum catecholamine levels, values indicate a decrease over the procedure. These patients underwent fracture reduction procedures which are typically associated with an increase in catecholamines.

2 secondary outcomes

Respiratory Depression
Time frame: From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status
Patient Reported Pain and Recall of the Painful Procedure for Which They Were Sedated Measure by Patient Query After They Had Regained Their Baseline Level of Consciousness After the Procedure
Time frame: single time point measured after sedation procedure completed

Results and safety

Results posted to the registry on 25 Sep 2014, 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	10	10
Propofol/Alfentanil	10	10

Primary outcome: Change in Serum Catecholamines

Time frame: one minute prior to the start of the procedure and immediately at the end of sedation procedure (median time of procedure 12 minutes range 6-26 minutes. Median (Inter-Quartile Range). Unit: mcg/ml

Measure	Propofol n = 10	Propofol/Alfentanil n = 10
Value	87 (1 to 353)	106 (21 to 295)

Propofol vs Propofol/Alfentanil: p = 0.940, Wilcoxon (Mann-Whitney)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Propofol	0 of 10 (0%)	0 of 10 (0%)	Not reported
Propofol/Alfentanil	0 of 10 (0%)	1 of 10 (10%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23701339Miner JR, Moore JC, Plummer D, Gray RO, Patel S, Ho JD. Randomized clinical trial of the effect of supplemental opioids in procedural sedation with propofol on serum catecholamines. Acad Emerg Med. 2013 Apr;20(4):330-7. doi: 10.1111/acem.12110.

Related trials for Sedation

Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruitingObservational study
Media Use, Anxiety, Sedation, and Recovery in Children Having Upper GI Endoscopy
Anesthesia, Anxiety

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 Faculty Associates

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 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: finished, as of the sponsor's last update on 25 Sep 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 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 25 Sep 2014). 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?

Change in Serum Catecholamines (time frame: one minute prior to the start of the procedure and immediately at the end of sedation procedure (median time of procedure 12 minutes range 6-26 minutes). 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 NCT00997113, which also lists 1 linked publication.

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 25 Sep 2014.