Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation - Full Text View

Sponsor:	Minneapolis Medical Research Foundation
Information provided by:	Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:	NCT00997126

Purpose

This is a clinical trial of propofol, alfentanil, and nitrous oxide as agents for moderated procedural sedation in patients undergoing sedation in the emergency department (ED).

Condition	Intervention	Phase
Sedation	Drug: Propofol Drug: Alfentanil Drug: Nitrous Oxide	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation in the Emergency Department

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Alfentanil hydrochloride Alfentanil Propofol Nitrous oxide

U.S. FDA Resources

Further study details as provided by Minneapolis Medical Research Foundation:

Primary Outcome Measures:

sub clinical respiratory depression and clinical events associated with respiratory depression [ Time Frame: From one minute prior to start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure (~3-60 minutes depending on procedure duration) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

time to return of baseline mental status [ Time Frame: single time point after completion of sedation procedure ] [ Designated as safety issue: No ]
depth of sedation [ Time Frame: single measurement during sedation procedure ] [ Designated as safety issue: Yes ]
patient reported pain [ Time Frame: single measurement immediately after patient returns to baseline mental status after sedation procedure ] [ Designated as safety issue: No ]
patient reported recall of the procedure [ Time Frame: single measurement immediately after patient returns to baseline mental status after sedation procedure ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Propofol Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation	Drug: Propofol Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation
Active Comparator: Alfentanil Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation	Drug: Alfentanil Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation
Active Comparator: Nitrous Oxide Sedation with inhaled nitrous oxide	Drug: Nitrous Oxide Nitrous oxide 30% inhaled, titrated to 70% prn sedation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adults undergoing moderate procedural sedation in the Emergency Department

Exclusion Criteria:

age <18 years
pregnancy
intoxicated
cannot give informed consent
allergy to any of the three study medications
ASA physical status score > 2
patients who require deep procedural sedation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997126

Contacts

Contact: James R Miner, MD

612-873-8791

miner015@umn.edu

Locations

United States, Minnesota
Hennepin County Medical Center	Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Roma Patel, MPH 612-873-9528 pate0209@umn.edu

Sponsors and Collaborators

Minneapolis Medical Research Foundation

Investigators

Principal Investigator:

James R Miner, MD

Minneapolis Medical Research Foundation

More Information

No publications provided

Responsible Party:	James R Miner MD, Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:	NCT00997126 History of Changes
Other Study ID Numbers:	MMRF093030
Study First Received:	October 12, 2009
Last Updated:	July 20, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Minneapolis Medical Research Foundation:

propofol
alfentanil
nitrous oxide
moderate procedural sedation
Moderate Procedural Sedation in the Emergency Department

Additional relevant MeSH terms:

Alfentanil
Propofol
Nitrous Oxide
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Analgesics, Non-Narcotic
Anesthetics, Inhalation
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on February 09, 2012