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Clinical Trials/NCT02404610
NCT02404610
Completed
Phase 4

Moderate Versus Deep Procedural Sedation With Propofol in the Emergency Department

Hennepin Healthcare Research Institute1 site in 1 country107 target enrollmentJuly 2014

Overview

Phase
Phase 4
Intervention
Moderate Procedural Sedation with a sedative medication.
Conditions
Pain
Sponsor
Hennepin Healthcare Research Institute
Enrollment
107
Locations
1
Primary Endpoint
Patients With Clinical Signs of Respiratory Depression or Sub Clinical Respiratory Depressions Measured by Capnography and Pulse Oximetry.
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
December 1, 2018
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adults undergoing procedural sedation with propofol in the emergency department

Exclusion Criteria

  • \< 18 years old
  • Previous allergic reaction to propofol
  • Unable to provide informed consent

Arms & Interventions

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.

Intervention: Moderate Procedural Sedation with a sedative medication.

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.

Intervention: propofol

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.

Intervention: Deep Procedural Sedation with a sedative medication.

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.

Intervention: propofol

Outcomes

Primary Outcomes

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

adverse respiratory events measured using capnography, pulse oximetry, and airway maneuvers performed during the sedation procedure

Study Sites (1)

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