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: 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 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

- Intoxication

- 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
Lila Steinberg, Phone: 612-873-9528, Email: research.hcmed@gmail.com

Starting date: October 2009
Last updated: April 10, 2015