Anesthesia, GeneralPREVANSNCT03267979
Assessing Pain in the Postoperative Period by Automatically Measuring the Variation Coefficient of Pupillary Diameter: PREVANS Study
A study testing Video-pupillometer and Electrocardiogram in people with Anesthesia, General, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Different pain assessment methods have been proposed to evaluate analgesic efficacy after surgical operation. Pain is a subjective phenomenon. Patient did his pain self assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Video-pupillometer and Electrocardiogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2014to 31 Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patients
- Patients fluent in French
- Patient admitted on the post anesthesia care units
Who cannot join
- Patients operated for all types of surgery except for heart, intra-cerebral, and ophthalmologic surgeries
- Emergency operation
- Heart rhythm disorders
- Pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Different pain assessment methods have been proposed to evaluate analgesic efficacy after surgical operation. Pain is a subjective phenomenon. Patient did his pain self assessment. But, cooperation of the patient is limited by cultural differences, language barriers or residual effect of products used while general anesthesia.
A lot of study were conducted to demonstrate and to quantify the pain after an operation. The aim will be dose analgesic treatment better without cooperation of the patient.
This sudy concerns patients on the post anesthesia care units one hour after their arrival. They will have electrocardiogram and video-pupillometer.
Read the detailed description
Primary objective is to compare Variation Coefficient of Pupillary Diameter (VCPD) obtained during a light flash and pain assessment realized thanks to Visual Analog Scale (VAS). Too, Variation Coefficient of Pupillary Diameter (VCPD) with electrocardiogram will be measured to demonstrate a correlation between the three parameters.
- Conditions
- Anesthesia, General
- Being tested
- Video-pupillometer, Electrocardiogram
- Keywords
- pain assessment, pupillary diameter, variation coefficient of pupillary diameter, pain self assessment, video-pupillometer, electrocardiogram, analgesic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-pupillometerOther
Also called Algiscan
Video-pupillometer will be performed. In this study data will be collected and analyzed.
ElectrocardiogramOther
Electrocardiogram will be performed. In this study data will be collected and analyzed.
| Study group | Role | What they receive |
|---|---|---|
| Patients have a surgical operation | Other | Patients have a surgical operation and have received analgesic treatment. One hour after the end of surgical patients will have electrocardiogram and video-pupillometer. Receives: Other: Video-pupillometer; Other: Electrocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between pupillary diameter (PD) and pain assessment
Correlation between pupillary diameter (PD) and pain in the post-operative period.
PD will be measured by video-pupillometer. Pain will be measured by Visual Analog Scale (VAS).
Measured: 1 hour post surgery
Secondary outcomes (1)
Correlation between pupillary diameter (PD) and heart rate
Correlation between pupillary diameter (PD) and heart rate in the post-operative period.
Heart rate will be measured by electrocardiogram.
Measured: 1 hour post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start2 Nov 2014
- Primary completion31 Mar 2015
- Study completion31 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David CHARIER, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267979
- Sponsor's protocol ID
- IRBN402014/CHUSTE
- Other IDs
- CNIL
- Acronym
- PREVANS
- Status last verified
- Aug 2017
- First submitted
- 25 Aug 2017
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Charier D, Vogler MC, Zantour D, Pichot V, Martins-Baltar A, Courbon M, Roche F, Vassal F, Molliex S. Assessing pain in the postoperative period: Analgesia Nociception IndexTMversus pupillometry. Br J Anaesth. 2019 Aug;123(2):e322-e327. doi: 10.1016/j.bja.2018.09.031. Epub 2019 Jan 26.
PubMed 30915996
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Pain in the Postoperative Period by Automatically Measuring the Variation Coefficient of Pupillary Diameter: PREVANS Study
- ClinicalTrials.gov ID
- NCT03267979
- Acronym / sponsor ID
- PREVANS / IRBN402014/CHUSTE
- Conditions
- Anesthesia, General
- Keywords
- pain assessment, pupillary diameter, variation coefficient of pupillary diameter, pain self assessment, video-pupillometer, electrocardiogram, analgesic treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 2 Nov 2014 (actual)
- Primary completion
- 31 Mar 2015 (actual)
- Study completion
- 31 Mar 2015 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Different pain assessment methods have been proposed to evaluate analgesic efficacy after surgical operation. Pain is a subjective phenomenon. Patient did his pain self assessment. But, cooperation of the patient is limited by cultural differences, language barriers or residual effect of products used while general anesthesia.
A lot of study were conducted to demonstrate and to quantify the pain after an operation. The aim will be dose analgesic treatment better without cooperation of the patient.
This sudy concerns patients on the post anesthesia care units one hour after their arrival. They will have electrocardiogram and video-pupillometer.
Detailed description
Primary objective is to compare Variation Coefficient of Pupillary Diameter (VCPD) obtained during a light flash and pain assessment realized thanks to Visual Analog Scale (VAS). Too, Variation Coefficient of Pupillary Diameter (VCPD) with electrocardiogram will be measured to demonstrate a correlation between the three parameters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients have a surgical operation | Other | Other: Video-pupillometer, Other: ElectrocardiogramPatients have a surgical operation and have received analgesic treatment. One hour after the end of surgical patients will have electrocardiogram and video-pupillometer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major patients
- Patients fluent in French
- Patient admitted on the post anesthesia care units
Key exclusion criteria (4 listed)
- Patients operated for all types of surgery except for heart, intra-cerebral, and ophthalmologic surgeries
- Emergency operation
- Heart rhythm disorders
- Pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-pupillometerAlso: AlgiscanVideo-pupillometer will be performed. In this study data will be collected and analyzed. | Other | Patients have a surgical operation |
| ElectrocardiogramElectrocardiogram will be performed. In this study data will be collected and analyzed. | Other | Patients have a surgical operation |
Primary outcome
Correlation between pupillary diameter (PD) and pain assessment
Time frame: 1 hour post surgery
Correlation between pupillary diameter (PD) and pain in the post-operative period. PD will be measured by video-pupillometer. Pain will be measured by Visual Analog Scale (VAS).
1 secondary outcome
Correlation between pupillary diameter (PD) and heart rate
Time frame: 1 hour post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Derived from this study: PubMed 30915996Charier D, Vogler MC, Zantour D, Pichot V, Martins-Baltar A, Courbon M, Roche F, Vassal F, Molliex S. Assessing pain in the postoperative period: Analgesia Nociception IndexTMversus pupillometry. Br J Anaesth. 2019 Aug;123(2):e322-e327. doi: 10.1016/j.bja.2018.09.031. Epub 2019 Jan 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David CHARIER, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-pupillometer and Electrocardiogram in people with Anesthesia, General, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between pupillary diameter (PD) and pain assessment (time frame: 1 hour post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03267979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017.