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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
  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 4

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
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 2013
Estimated Primary Completion Date: October 2013 (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
  • Intoxication
  • 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: Lila Steinberg     612-873-9528     research.hcmed@gmail.com    
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: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00997126     History of Changes
Other Study ID Numbers: MMRF093030
Study First Received: October 12, 2009
Last Updated: January 23, 2013
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 May 22, 2013