NCT01401049

Brief Summary

The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 26, 2015

Completed
Last Updated

December 29, 2017

Status Verified

December 1, 2017

Enrollment Period

1.9 years

First QC Date

June 17, 2011

Results QC Date

December 22, 2014

Last Update Submit

December 4, 2017

Conditions

Complication of InjectionPain

Keywords

FospropofolPropofolColonoscopyLusedra

Outcome Measures

Primary Outcomes (1)

  • Compare Incidence and Intensity of Pain on Injection That is Caused by Propofol (Lipid Emulsion) Versus the Test Drug Fospropofol.

    We hypothesize that we can reject the null hypothesis that results from all 3 arms are from the same sample, and then show (in pair wise tests) that fospropofol is superior to propofol, and not-inferior to propofol plus lidocaine.

    2 hours

Secondary Outcomes (1)

  • To Compare Patient Satisfaction With Sedation Including the Recall of Pain.

    2 hours after the end of the procedure.

Study Arms (2)

Fospropofol

EXPERIMENTAL

To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.

Drug: Fospropofol

Propofol/Lidocaine

ACTIVE COMPARATOR

The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).

Drug: Propofol/Lidocaine

Interventions

FospropofolDRUG

To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.

Fospropofol
Propofol/LidocaineDRUG

We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion).

Also known as: Propofol, Fospropofol, Pain on Injection
Propofol/Lidocaine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) I, II or III.
  • Age 18 - 65.
  • Both male and female.
  • No significant laboratory abnormalities.

You may not qualify if:

  • Chronic pain patients or patients receiving benzodiazepines or opioids / other analgesics for control of acute pain will be excluded.
  • Patients with known allergies to any of the study drugs, or to soybean oil or egg lecithin are excluded.
  • Women with a positive pregnancy test reported from pre-surgical testing or their physician's office or who are breast feeding at the time of surgery.
  • No emergency patients will be recruited for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Pain

Interventions

fospropofolPropofolLidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Results Point of Contact

Title
Mitchell Lee, MD
Organization
NYU School of Medicine
mitchell.lee@nyumc.org
212.263.5071

Study Officials

  • Mitchell Lee, MD

    NYU Langone Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2011

First Posted

July 25, 2011

Study Start

August 1, 2010

Primary Completion

July 1, 2012

Study Completion

January 1, 2013

Last Updated

December 29, 2017

Results First Posted

January 26, 2015

Record last verified: 2017-12

Locations

US(1)