Stress During Deep Sedation With Propofol With and Without Alfentanil

NCT00997113 | Completed Phase 4 Results DMC

• 1 other identifier: MMRF093051
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sedation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Serum Catecholamines

  change in serum catecholamine levels, values indicate a decrease over the procedure. These patients underwent fracture reduction procedures which are typically associated with an increase in catecholamines.

  one minute prior to the start of the procedure and immediately at the end of sedation procedure (median time of procedure 12 minutes range 6-26 minutes

Secondary Outcomes (2)

• Respiratory Depression

  From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status

• Patient Reported Pain and Recall of the Painful Procedure for Which They Were Sedated Measure by Patient Query After They Had Regained Their Baseline Level of Consciousness After the Procedure

  single time point measured after sedation procedure completed

Study Arms (2)

Propofol

ACTIVE COMPARATOR

propofol only for deep procedural sedation

Drug: propofol

Propofol/alfentanil

ACTIVE COMPARATOR

Propofol with alfentanil for deep procedural sedation

Drug: propofol; Drug: alfentanil

Interventions

propofol DRUG

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

Propofol; Propofol/alfentanil

alfentanil DRUG

alfentanil 10 ug/kg immediately prior to propofol dose

Propofol/alfentanil

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• age \<18
• intoxication
• unable to provide informed consent
• allergy to propofol or alfentanil
• pregnant
• ASA physical status score \> 2

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

• Miner JR, Moore JC, Plummer D, Gray RO, Patel S, Ho JD. Randomized clinical trial of the effect of supplemental opioids in procedural sedation with propofol on serum catecholamines. Acad Emerg Med. 2013 Apr;20(4):330-7. doi: 10.1111/acem.12110.

  PMID: 23701339 RESULT

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

Results Point of Contact

• Title: James Miner
• Organization: Minneapolis Medical Reseach Foundation

miner015@umn.edu

6128738791

Study Officials

• James R. Miner, MD

  Hennepin Faculty Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• 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: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 25, 2014
• Results First Posted: September 25, 2014

Record last verified: 2014-09

Locations

US (1)