Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 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: October 23, 2014
Last verified: October 2014
  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:


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 2014
Estimated Primary Completion Date: October 2014 (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
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

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: October 23, 2014
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
Nitrous Oxide
Propofol
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Inhalation
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014