Ignite Creation Date:
2024-05-06 @ 12:53 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01685645
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2012-09-12
Brief Title:
Does the Measurement of Pupillary Reactivity by an Automated Pupillometer Determine the Effectiveness of Local Anesthesia Under General Anesthesia
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Centre Hospitalier Universitaire de Nīmes
Study Overview
Official Title:
Does the Measurement of Pupillary Reactivity to Painful Stimulation by an Automated Pupillometer Determine the Effectiveness of Local Anesthesia When Undergoing General Anesthesia
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALGISCAN
Brief Summary:
The pupillary pain-meter AlgiScan with integrated nociceptive stimulator is a portable battery-operated device which automatically measures by means of an infrared camera pupil diameter This is measured in response to noxious stimulation produced by a tetanus at a frequency of 100 Hz for 5 seconds Its intensity varies from 10 to 60 mA The recording is performed for a period of 13 seconds 3 seconds prior to stimulation stimulation for 5 seconds 5 seconds after the stimulation An interval of 3 minutes is allowed between the two measurements right and left which is significantly higher than the time necessary to return to normal about 20seconds
The pupillary pain index PPI ranges from 0 to 10 and is a composite measure of the pupillary diameter reflex to the tetanus stimuli delivered by the AlgiScan device Smaller scores indicate increased analgesia
The main objective of this study is to determine whether PPI index variation can determine a prognostic threshold of analgesic efficacy of unilateral lower limb sensory nerve block before incision The measurements are performed after bilateral nociceptive stimulation blocked side versus non-blocked side in patients under general anesthesia for major knee surgery
The pupillary pain index PPI ranges from 0 to 10 and is a composite measure of the pupillary diameter reflex to the tetanus stimuli delivered by the AlgiScan device Smaller scores indicate increased analgesia
The main objective of this study is to determine whether PPI index variation can determine a prognostic threshold of analgesic efficacy of unilateral lower limb sensory nerve block before incision The measurements are performed after bilateral nociceptive stimulation blocked side versus non-blocked side in patients under general anesthesia for major knee surgery
Detailed Description:
The secondary objectives of this study are to find a link between the clinical criteria for block failure and the ratio of the blocked side PPI over the unblocked side PPI
study the potential link between algic thermal sensitivity tested prior to general anesthesia and the blocked side PPI or the asymmetry of the index between the blocked side and the unblocked side
study the potential link between postoperative morphine consumption and the blocked side PPI index or the asymmetry of the index between the blocked side and the unblocked side
study the potential link between consumption of remifentanil during surgery and the blocked side PPI index or the asymmetry of the index between the blocked side and the unblocked side
study the potential link between the hemodynamic response to incision and the blocked side PPI index or the asymmetry of the index between the blocked side and the unblocked side
study the potential link between morning pain assessment and the blocked side PPI index or the asymmetry of the index between the blocked side and the unblocked side
study the potential link between algic thermal sensitivity tested prior to general anesthesia and the blocked side PPI or the asymmetry of the index between the blocked side and the unblocked side
study the potential link between postoperative morphine consumption and the blocked side PPI index or the asymmetry of the index between the blocked side and the unblocked side
study the potential link between consumption of remifentanil during surgery and the blocked side PPI index or the asymmetry of the index between the blocked side and the unblocked side
study the potential link between the hemodynamic response to incision and the blocked side PPI index or the asymmetry of the index between the blocked side and the unblocked side
study the potential link between morning pain assessment and the blocked side PPI index or the asymmetry of the index between the blocked side and the unblocked side
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-A01095-38 | OTHER | RCB number | None |