Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation
Information source: Minneapolis Medical Research Foundation
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sedation
Intervention: Propofol (Drug); Alfentanil (Drug); Nitrous Oxide (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Minneapolis Medical Research Foundation Official(s) and/or principal investigator(s): James R Miner, MD, Principal Investigator, Affiliation: Minneapolis Medical Research Foundation
Overall contact: James R Miner, MD, Phone: 612-873-8791, Email: miner015@umn.edu
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).
Clinical Details
Official title: Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation in the Emergency Department
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Sub-clinical respiratory depression and clinical events associated with respiratory depression
Secondary outcome: Time to return of baseline mental statusDepth of sedation Patient reported pain Patient reported recall of the procedure
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
James R Miner, MD, Phone: 612-873-8791, Email: miner015@umn.edu
Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States; Recruiting Lila Steinberg, Phone: 612-873-9528, Email: research.hcmed@gmail.com
Additional Information
Starting date: October 2009
Last updated: April 10, 2015
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