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Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00997126
First received: October 12, 2009
Last updated: December 1, 2016
Last verified: December 2016
  Purpose
This is a clinical trial of propofol and alfentanil as agents for moderated procedural sedation in patients undergoing sedation in the emergency department (ED).

Condition Intervention Phase
Sedation Drug: Propofol Drug: Alfentanil Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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:


Further study details as provided by Minneapolis Medical Research Foundation:

Primary Outcome Measures:
  • Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure [ 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) ]

Secondary Outcome Measures:
  • Time to Return of Baseline Mental Status From Start of Procedure in Minutes [ Time Frame: Single time point after completion of sedation procedure, measured from start of procedure until the patient returns to baseline mental status up to 24 hours ]
  • Depth of Sedation Measured Using the OAAS Scale [ Time Frame: Single measurement during sedation procedure ]
    Observers Assesment of Alertness Scale, 5 responds normally to voice, 4 lethargic response to voice, 3 responds only to loud voice or light touch, 2 responds only to mild prodding or shaking, 1 responds only to painful stimuli, 0 no response to painful stimuli

  • Patient Reported Pain [ Time Frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure ]
  • Patient Reported Recall of the Procedure [ Time Frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure ]

Enrollment: 126
Study Start Date: October 2009
Study Completion Date: April 2015
Primary Completion Date: April 2015 (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

Detailed Description:
This was initially going to be a trial of propofol vs alfentanil vs nitrous oxide, but our use of nitrous oxide was discontinued before the trial began and the trial was conducted with only two arms
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Minneapolis Medical Research Foundation
Investigators
Principal Investigator: James R Miner, MD Minneapolis Medical Research Foundation
  More Information

Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00997126     History of Changes
Other Study ID Numbers: MMRF093030
Study First Received: October 12, 2009
Results First Received: September 12, 2016
Last Updated: December 1, 2016

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:
Propofol
Alfentanil
Nitrous Oxide
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Inhalation
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics

ClinicalTrials.gov processed this record on July 21, 2017