Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation

This study is currently recruiting participants.

Verified January 2013 by Minneapolis Medical Research Foundation

Sponsor:

Information provided by (Responsible Party):

Minneapolis Medical Research Foundation

ClinicalTrials.gov Identifier:

NCT00997126

First received: October 12, 2009

Last updated: January 23, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 12, 2009

Last Updated Date

January 23, 2013

Start Date ^ICMJE

October 2009

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00997126 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation

Official Title ^ICMJE

Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation in the Emergency Department

Brief Summary

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Sedation

Intervention ^ICMJE

Drug: Propofol
Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation
Drug: Alfentanil
Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation
Drug: Nitrous Oxide
Nitrous oxide 30% inhaled, titrated to 70% prn sedation

Study Arm (s)

Active Comparator: Propofol
Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation

Intervention: Drug: Propofol
Active Comparator: Alfentanil
Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation

Intervention: Drug: Alfentanil
Active Comparator: Nitrous Oxide
Sedation with inhaled nitrous oxide

Intervention: Drug: Nitrous Oxide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

October 2013

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adults undergoing moderate procedural sedation in the Emergency Department

Exclusion Criteria:

Age <18 years
Pregnancy
Intoxication
Cannot give informed consent
Allergy to any of the three study medications
ASA physical status score > 2
Patients who require deep procedural sedation

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: James R Miner, MD

612-873-8791

miner015@umn.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00997126

Other Study ID Numbers ^ICMJE

MMRF093030

Has Data Monitoring Committee

Yes

Responsible Party

Minneapolis Medical Research Foundation

Study Sponsor ^ICMJE

Minneapolis Medical Research Foundation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

James R Miner, MD

Minneapolis Medical Research Foundation

Information Provided By

Minneapolis Medical Research Foundation

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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