A Phase 4 interventional study of Moderate Procedural Sedation with a sedative medication. and Deep Procedural Sedation with a sedative medication. in Pain, sponsored by Hennepin Healthcare Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-30.
Sponsored by Hennepin Healthcare Research Institute · Phase 4, Interventional, and Treatment
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.
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.
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's enrollment of 107 is below the median of 145 across 931 interventional studies indexed under Emergencies.
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Exclusion Criteria:
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.
Procedure: Moderate Procedural Sedation with a sedative medication. · Drug: propofol
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.
Procedure: Deep Procedural Sedation with a sedative medication. · Drug: propofol
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.
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.
Patients With Clinical Signs of Respiratory Depression or Sub Clinical Respiratory Depressions Measured by Capnography and Pulse Oximetry.
adverse respiratory events measured using capnography, pulse oximetry, and airway maneuvers performed during the sedation procedure
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
| Milestone | Moderate Procedural Sedation | Deep Procedural Sedation |
|---|---|---|
| Started | 54 | 53 |
| Completed | 54 | 53 |
| Not completed | 0 | 0 |
adverse respiratory events measured using capnography, pulse oximetry, and airway maneuvers performed during the sedation procedure
| Participants | Moderate Procedural Sedation | Deep Procedural Sedation |
|---|---|---|
| Patients With Clinical Signs of Respiratory Depression or Sub Clinical Respiratory Depressions Measured by Capnography and Pulse Oximetry. | 22 | 21 |
Collected over From 3 minutes prior to the start of the sedation encounter up until the time the patient regained their baseline mental status up to 24 hours.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Moderate Procedural Sedation | 0/54 (0%) | 0/54 (0%) | 21/54 (38.9%) |
| Deep Procedural Sedation | 0/53 (0%) | 0/53 (0%) | 24/53 (45.3%) |
| Event | Moderate Procedural Sedation | Deep Procedural Sedation |
|---|---|---|
| adverse respiratory eventRespiratory, thoracic and mediastinal disorders | 21/54 | 24/53 |
| Age, Categorical(Participants) | Moderate Procedural Sedation | Deep Procedural Sedation | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 51 | 49 | 100 |
| >=65 years | 3 | 4 | 7 |
| Age, Continuous(years) | Moderate Procedural Sedation | Deep Procedural Sedation | Total |
|---|---|---|---|
| Median | 41.5 (18 to 78) | 39 (20 to 73) | 40 (18 to 78) |
| Sex: Female, Male(Participants) | Moderate Procedural Sedation | Deep Procedural Sedation | Total |
|---|---|---|---|
| Female | 30 | 25 | 55 |
| Male | 24 | 28 | 52 |
| Race and Ethnicity Not Collected(Participants) | Moderate Procedural Sedation | Deep Procedural Sedation | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Moderate Procedural Sedation | Deep Procedural Sedation | Total |
|---|---|---|---|
| United States | 54 | 53 | 107 |
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Hennepin Healthcare Research Institute