Clinical trial NCT02404610
Conditions: Pain
Keywords: propofol moderate procedural sedation deep procedural sedation memory emergency department
Sponsor: Hennepin Healthcare Research Institute
Start date: 2014-07-01; Completion date: 2018-12-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

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.

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: Moderate Procedural Sedation with a sedative medication. intervention 2: Deep Procedural Sedation with a sedative medication. intervention 3: propofol
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: None

Protocol documents:
Prot_SAP_000.pdf: