Complication of Injection, Pain
Conditions
Keywords
Fospropofol, Propofol, Colonoscopy, Lusedra
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).
Detailed description
Propofol (2,6-diisopropylphenol) is one of the most common induction and sedative agents used today. Properties that make this agent popular include rapid onset and quick recovery. However, as its use became more widespread, side effects such as pain on injection have attracted more attention. The incidence of pain on propofol injection is as high as 70 - 90%. Numerous studies report that more than 50% of patients recall the unpleasant burning sensation during injection. Many techniques to minimize pain on injection associated with propofol have been described; pre-administration of different medications including lidocaine, ketamine, thiopental, metoclopramide, dexamethasone, ondansetron, and remifentanil have been reported with mixed success. Some have even tried to use lidocaine with a tourniquet. Others have reported the use of distraction techniques including counting numbers aloud. Recently, a solvent mixture of medium chain triglyceride and long chain triglyceride has been tested for prevention of pain on propofol injection. Lusedra (fospropofol disodium), the water-soluble prodrug of propofol, does not cause pain on injection as it is water based medication. Demonstrating the benefit of fospropofol over propofol in patient satisfaction will improve acceptance by anesthesia providers.
Interventions
DRUGFospropofol
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.
DRUGPropofol/Lidocaine
We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion).
Sponsors
Eisai Inc.
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) I, II or III. * Age 18 - 65. * Both male and female. * No significant laboratory abnormalities.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare Incidence and Intensity of Pain on Injection That is Caused by Propofol (Lipid Emulsion) Versus the Test Drug Fospropofol. | 2 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Compare Patient Satisfaction With Sedation Including the Recall of Pain. | 2 hours after the end of the procedure. | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| 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). | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: 2 hours
Population: Due to flooding from Hurricane Sandy at our site, all files and pertinent patient data were lost.
Secondary
To Compare Patient Satisfaction With Sedation Including the Recall of Pain.
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.
Time frame: 2 hours after the end of the procedure.
Population: No data displayed because Outcome Measure has zero total participants analyzed.