- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00997126
Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation
December 1, 2016 updated by: Hennepin Healthcare Research Institute
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).
Study Overview
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 Type
Interventional
Enrollment (Actual)
126
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults undergoing moderate procedural sedation in the Emergency Department
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Propofol
Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation
|
Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation
|
Active Comparator: Alfentanil
Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation
|
Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
Single measurement during sedation procedure
|
Patient Reported Pain
Time Frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure
|
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
|
Single measurement immediately after patient returns to baseline mental status after sedation procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
October 12, 2009
First Submitted That Met QC Criteria
October 16, 2009
First Posted (Estimate)
October 19, 2009
Study Record Updates
Last Update Posted (Estimate)
January 27, 2017
Last Update Submitted That Met QC Criteria
December 1, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMRF093030
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sedation
-
I.M. Sechenov First Moscow State Medical UniversityCompleted
-
Davinia WithingtonUnknownSedation | Mechanical Ventilation | Daily Sedative Interruption | Sedation Strategies | Sedation ProtocolsCanada
-
University Hospital Inselspital, BerneGE HealthcareCompletedCritical Care | Conscious Sedation | Deep SedationSwitzerland
-
Seoul National University HospitalRecruiting
-
National Taiwan University HospitalCompleted
-
Paion UK Ltd.Premier Research Group plcCompleted
-
Washington University School of MedicineWithdrawn
Clinical Trials on Propofol
-
Hopital FochCompleted
-
University Medical Center GroningenCompletedAnesthesia | Hemodynamic Instability | Interaction | Disorder of Oxygen TransportNetherlands
-
Konkuk University Medical CenterCompletedCoronary Artery Disease | Valvular Heart DiseaseKorea, Republic of
-
Asan Medical CenterCompletedPopulation Pharmacokinetics/Pharmacodynamics (PK/PD) of Microemulsion Propofol in Healthy VolunteersHealthyKorea, Republic of
-
Tiva GroupMedtronic - MITGCompleted
-
Pontificia Universidad Catolica de ChileCompletedSurgery | Anesthesia | Depth of Anesthesia | NeonateChile
-
Mansoura UniversityCompleted
-
KVG Medical College and HospitalUnknown
-
Universitaire Ziekenhuizen KU LeuvenCompletedCoronary Artery Disease | AnesthesiaBelgium