Moderate Versus Deep Procedural Sedation With Propofol in the Emergency Department

November 3, 2021 updated by: Hennepin Healthcare Research Institute
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.

Study Overview

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

Interventional

Enrollment (Actual)

107

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alexandra Schick, Hennepin Healthcare Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Actual)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 3, 2021

Last Verified

November 1, 2021

More Information

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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