Stress During Deep Sedation With Propofol With and Without Alfentanil

Condition(s) targeted: Sedation

Intervention: propofol (Drug); alfentanil (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: Hennepin Faculty Associates

This is a randomized clinical trial of deep procedural sedation with propofol with and without supplemental alfentanil. Patients will be assessed for total and fractionated serum catecholamines before and after the procedure in addition to usual procedural sedation outcomes parameters to assess the adrenergic effect of propofol sedation without supplemental opioid.

Official title: Physiologic Stress During Procedural Sedation With and Without Alfentanil

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

Primary outcome: serum catecholamines

Secondary outcome:

respiratory depression

patient reported pain and recall

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- patients who will require deep procedural sedation with propofol in the ED

Exclusion Criteria:

- age <18

- intoxication

- unable to provide informed consent

- allergy to propofol or alfentanil

- pregnant

- ASA physical status score > 2

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 2010
Last updated: October 16, 2009