- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02404610
Moderate Versus Deep Procedural Sedation With Propofol in the Emergency Department
Study Overview
Status
Conditions
Detailed Description
Purpose: For the pilot phase, if the visual memory assessment test developed in this study can adequately assess periods of amnesia during the procedure, then it can be used for the phase of the study that randomizes patients to moderate or deep sedation. The purpose of the randomized phase is to compare the rate of amnesia and respiratory depression in patients who receive moderate sedation to those that received deep sedation. The goal is to determine whether moderate sedation could provide a safer sedation while still resulting in adequate amnesia of the procedure. Secondary goals would be to compare the duration of sedation, the success of the procedures for which the patient is sedated, procedural difficulty, the rate of hypotension and other adverse events, and the patient perception of the quality of the sedation (pain or recall of procedure).
Background: Adequate pain control and alleviation of anxiety improves quality of care and patient satisfaction. Numerous studies have found that procedural sedation (PS) in the ED is safe, and when properly administered, the incidence of reported complications, including clinically significant respiratory depression, is rare. Procedural sedation is used for procedures such as fracture reduction, dislocation reduction, cardioversion, incision and drainage, and chest tube placement. Propofol is an anesthetic agent frequently used for PS in the Emergency Department (ED) and produces sedation, hypnosis, and amnesia, but lacks analgesic properties. In studies conducted at Hennepin County Medical Center (HCMC), we have found that patients are unable to recall whether or not they experienced pain during the procedure when sedated with propofol. However, there is the possibility that certain parts of the procedure can be later recalled by the patient. If extensive parts of the procedure can be recalled, then this is not an effective sedation. Previous studies of memory during sedation at HCMC have used verbal prompts only, but research has shown that people can more readily remember images. Images may provide a more sensitive way to determine the degree of amnesia during sedation.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults undergoing procedural sedation with propofol in the emergency department
Exclusion Criteria:
- < 18 years old
- Pregnant
- Previous allergic reaction to propofol
- Prisoner
- Unable to provide informed consent
Study Plan
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 |
---|---|
Experimental: Moderate Procedural Sedation
Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of moderate sedation.
Moderate procedural sedation is a specific term referring to procedural sedation with a target depth of moderate.
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procedural sedation with a target sedation depth of moderate.
Moderate sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids.
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Experimental: Deep Procedural Sedation
Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of deep sedation.
Deep procedural sedation is a specific term referring to procedural sedation with a target depth of deep.
|
procedural sedation with a target sedation depth of deep.
Deep sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients With Clinical Signs of Respiratory Depression or Sub Clinical Respiratory Depressions Measured by Capnography and Pulse Oximetry.
Time Frame: From start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure, an expected average time of 30 minutes
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adverse respiratory events measured using capnography, pulse oximetry, and airway maneuvers performed during the sedation procedure
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From start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure, an expected average time of 30 minutes
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Collaborators and Investigators
Investigators
- Principal Investigator: Alexandra Schick, Hennepin Healthcare Research Institute
Publications and helpful links
General Publications
- Miner JR, Danahy M, Moch A, Biros M. Randomized clinical trial of etomidate versus propofol for procedural sedation in the emergency department. Ann Emerg Med. 2007 Jan;49(1):15-22. doi: 10.1016/j.annemergmed.2006.06.042. Epub 2006 Sep 25.
- Miner JR, Biros M, Krieg S, Johnson C, Heegaard W, Plummer D. Randomized clinical trial of propofol versus methohexital for procedural sedation during fracture and dislocation reduction in the emergency department. Acad Emerg Med. 2003 Sep;10(9):931-7. doi: 10.1111/j.1553-2712.2003.tb00646.x.
- Miner JR, Biros MH, Seigel T, Ross K. The utility of the bispectral index in procedural sedation with propofol in the emergency department. Acad Emerg Med. 2005 Mar;12(3):190-6. doi: 10.1197/j.aem.2004.10.004.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSR 13-3746
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.
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