Trial Outcomes & Findings for Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol (NCT NCT01401049)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

116 participants

Primary outcome timeframe

2 hours

Results posted on

2017-12-29

Participant Flow

Patients were recruited from Tisch Hospital, part of New York University (NYU) Langone Medical Center. An additional site was opened, Research Associates of New York (RANY). All patients having either a colonoscopy or upper endoscopy, or both, were considered.

Participant milestones

Participant milestones
Measure	Fospropofol 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: 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.	Propofol/Lidocaine 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). Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion).
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 2 hours

Population: Due to flooding from Hurricane Sandy at our site, all files and pertinent patient data were lost.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 hours after the end of the procedure.

Population: No data displayed because Outcome Measure has zero total participants analyzed.

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.

Outcome measures

Outcome data not reported

Adverse Events

Fospropofol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Propofol/Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mitchell Lee, MD

NYU School of Medicine

Phone: 212.263.5071

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place