Moderate Versus Deep Procedural Sedation With Propofol in the Emergency Department

NCT02404610 | Completed Phase 4 Results

• 1 other identifier: HSR 13-3746
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

propofol; moderate procedural sedation; deep procedural sedation; memory; emergency department

Outcome Measures

Primary Outcomes (1)

• 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

  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

Study Arms (2)

Moderate Procedural Sedation

EXPERIMENTAL

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

Deep Procedural Sedation

EXPERIMENTAL

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

Interventions

Moderate Procedural Sedation with a sedative medication. PROCEDURE

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.

Moderate Procedural Sedation

Deep Procedural Sedation with a sedative medication. PROCEDURE

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.

Deep Procedural Sedation

propofol DRUG

Deep Procedural Sedation; Moderate Procedural Sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults undergoing procedural sedation with propofol in the emergency department

You may not qualify if:

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

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (3)

• Miner JR, Danahy M, Moch A, Biros M. Randomized clinical trial of etomidate versus propofol for procedural sedation in the emergency department. Ann Emerg Med. 2007 Jan;49(1):15-22. doi: 10.1016/j.annemergmed.2006.06.042. Epub 2006 Sep 25.

  PMID: 16997421 BACKGROUND

• Miner JR, Biros M, Krieg S, Johnson C, Heegaard W, Plummer D. Randomized clinical trial of propofol versus methohexital for procedural sedation during fracture and dislocation reduction in the emergency department. Acad Emerg Med. 2003 Sep;10(9):931-7. doi: 10.1111/j.1553-2712.2003.tb00646.x.

  PMID: 12957974 BACKGROUND

• Miner JR, Biros MH, Seigel T, Ross K. The utility of the bispectral index in procedural sedation with propofol in the emergency department. Acad Emerg Med. 2005 Mar;12(3):190-6. doi: 10.1197/j.aem.2004.10.004.

  PMID: 15741580 BACKGROUND

MeSH Terms

Conditions

Pain; Emergencies

Interventions

Propofol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Audrey Hendrickson
• Organization: Hennepin Healthcare

audrey.hendrickson@hcmed.org

6128739528

Study Officials

• Alexandra Schick

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: March 31, 2015
• Study Start: July 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 30, 2021
• Results First Posted: May 24, 2019

Record last verified: 2021-11

Locations

US (1)