Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation

NCT00997126 | Completed Phase 4 Results DMC

• 1 other identifier: MMRF093030
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical trial of propofol and alfentanil as agents for moderated procedural sedation in patients undergoing sedation in the emergency department (ED).

Conditions

Sedation

Keywords

propofol; alfentanil; nitrous oxide; moderate procedural sedation; Moderate Procedural Sedation in the Emergency Department

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure

  From one minute prior to start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure (~3-60 minutes depending on procedure duration)

Secondary Outcomes (4)

• Time to Return of Baseline Mental Status From Start of Procedure in Minutes

  Single time point after completion of sedation procedure, measured from start of procedure until the patient returns to baseline mental status up to 24 hours

• Depth of Sedation Measured Using the OAAS Scale

  Single measurement during sedation procedure

• Patient Reported Pain

  Single measurement immediately after patient returns to baseline mental status after sedation procedure

• Patient Reported Recall of the Procedure

  Single measurement immediately after patient returns to baseline mental status after sedation procedure

Study Arms (2)

Propofol

ACTIVE COMPARATOR

Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation

Drug: Propofol

Alfentanil

ACTIVE COMPARATOR

Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation

Drug: Alfentanil

Interventions

Propofol DRUG

Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation

Propofol

Alfentanil DRUG

Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation

Alfentanil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults undergoing moderate procedural sedation in the Emergency Department

You may not qualify if:

• 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

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Interventions

Propofol; Alfentanil

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

our capability of administering nitrous oxide was diminished as the trial was started, and the trial was conducted using on the propofol and alfentanil arms.

Results Point of Contact

• Title: James Miner
• Organization: MinneapolisMRF

miner015@umn.edu

6128732493

Study Officials

• James R Miner, MD

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2009
• First Posted: October 19, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 27, 2017
• Results First Posted: January 27, 2017

Record last verified: 2016-12

Locations

US (1)