Stress During Deep Sedation With Propofol With and Without Alfentanil

This study is currently recruiting participants.

Verified by Minneapolis Medical Research Foundation, October 2009

First Received: October 12, 2009 Last Updated: October 16, 2009 History of Changes

Sponsor:	Minneapolis Medical Research Foundation
Information provided by:	Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:	NCT00997113

Purpose

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.

Condition	Intervention	Phase
Sedation	Drug: propofol Drug: alfentanil	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Physiologic Stress During Procedural Sedation With and Without Alfentanil

Resource links provided by NLM:

Drug Information available for: Alfentanil hydrochloride Alfentanil Propofol

U.S. FDA Resources

Further study details as provided by Minneapolis Medical Research Foundation:

Primary Outcome Measures:

serum catecholamines [ Time Frame: one minute prior and immediately at the end of sedation procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

respiratory depression [ Time Frame: From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status ] [ Designated as safety issue: Yes ]
patient reported pain and recall [ Time Frame: single time point measured during sedation procedure ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Propofol: Active Comparator propofol only for deep procedural sedation	Drug: propofol 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation
Propofol/alfentanil: Active Comparator Propofol with alfentanil for deep procedural sedation	Drug: propofol 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation Drug: alfentanil alfentanil 10 ug/kg immediately prior to propofol dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997113

Locations

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

Sponsors and Collaborators

Minneapolis Medical Research Foundation

Investigators

Principal Investigator:

James R. Miner, MD

Hennepin Faculty Associates

More Information

No publications provided

Responsible Party:	Minneapolis Medical Research Foundation ( James R Miner, MD )
Study ID Numbers:	MMRF093051
Study First Received:	October 12, 2009
Last Updated:	October 16, 2009
ClinicalTrials.gov Identifier:	NCT00997113 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Minneapolis Medical Research Foundation:

propofol
alfentanil
procedural sedation
stress biomarkers
Deep procedural sedation in the ED

Additional relevant MeSH terms:

Anesthetics, Intravenous
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Alfentanil
Narcotics
Pharmacologic Actions
Sensory System Agents

Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Peripheral Nervous System Agents
Propofol
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010