Moderate Versus Deep Procedural Sedation With Propofol in the Emergency Department
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Hospital |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2014 |
| End Date: | July 2016 |
| Contact: | Alexandra Schick |
| Email: | schic106@umn.edu |
| Phone: | 612-873-8791 |
This study is a clinical trial of moderate sedation versus deep sedation with propofol for
procedural sedation in the Emergency Department. The purpose of this study is to compare the
rate of amnesia and respiratory depression rate in patients who receive moderate sedation to
those that receive deep sedation.
procedural sedation in the Emergency Department. The purpose of this study is to compare the
rate of amnesia and respiratory depression rate in patients who receive moderate sedation to
those that receive deep sedation.
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.
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.
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
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