Stress During Deep Sedation With Propofol With and Without Alfentanil

This study is currently recruiting participants.

Verified July 2011 by Minneapolis Medical Research Foundation

First Received on October 12, 2009. Last Updated on July 20, 2011 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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:	December 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Propofol propofol only for deep procedural sedation	Drug: propofol 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation
Active Comparator: Propofol/alfentanil 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:	James R Miner, MD, Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:	NCT00997113 History of Changes
Other Study ID Numbers:	MMRF093051
Study First Received:	October 12, 2009
Last Updated:	July 20, 2011
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:

Alfentanil
Propofol
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents

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

ClinicalTrials.gov processed this record on February 09, 2012