Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation

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

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).

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: sub clinical respiratory depression and clinical events associated with respiratory depression

Secondary outcome:

time to return of baseline mental status

depth of sedation

patient reported pain

patient reported recall of the procedure

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

- intoxicated

- cannot give informed consent

- allergy to any of the three study medications

- ASA physical status score > 2

- patients who require deep procedural sedation

James R Miner, MD, Phone: 612-873-8791, Email: miner015@umn.edu

Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States; Recruiting
Roma Patel, MPH, Phone: 612-873-9528, Email: pate0209@umn.edu

Starting date: October 2009
Ending date: October 2011
Last updated: October 16, 2009