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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 January 2013 |
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Main ID: |
NCT00997126 |
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Date of registration:
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12/10/2009 |
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Primary sponsor: |
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Public title:
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Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation
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Scientific title:
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Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation in the Emergency Department |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00997126 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Lila Steinberg |
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Address:
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Telephone:
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612-873-9528 |
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Email:
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research.hcmed@gmail.com |
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Affiliation:
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Name:
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James R Miner, MD |
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Address:
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Telephone:
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612-873-8791 |
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Email:
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miner015@umn.edu |
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Affiliation:
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Name:
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James R Miner, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Minneapolis Medical Research Foundation |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sedation
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Intervention(s)
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Drug: Alfentanil
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Drug: Nitrous Oxide
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Drug: Propofol
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Primary Outcome(s)
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Sub-clinical respiratory depression and clinical events associated with respiratory depression
[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)]
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Secondary Outcome(s)
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Depth of sedation
[Time Frame: Single measurement during sedation procedure]
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Patient reported pain
[Time Frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure]
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Patient reported recall of the procedure
[Time Frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure]
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Time to return of baseline mental status
[Time Frame: Single time point after completion of sedation procedure]
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Secondary ID(s)
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MMRF093030
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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