PainNCT04465773
Pupillary Response to Incremental Tetanic Stimulations Under Propofol-remifentanil TCI
A study testing general anesthesia for scheduled gynecological surgery, Propofol and Remifentanil, Ultiva® in people with Pain, run by Pr Isabelle CONSTANT at 1 site in France.
Trial summary
In patients under standardized steady-state general anesthesia, 6 tetanic stimulations of incremental intensities were applied to the patients. Pupillary dilation in response to these stimulations was recorded. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- general anesthesia for scheduled gynecological surgery, Propofol and Remifentanil, Ultiva®
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Jul 2013
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled gynecological surgery requiring general anesthesia and orotracheal intubation
- written informed consent
Who cannot join
- ophthalmic disease
- neurologic disease
- preoperative chronic pain or pain medication
- medication interfering with autonomous nervous system (beta blockers, alpha agonists, metoclopramide, droperidol, atropine, catecholamines)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pupillary Diameter Variations in Response to Tetanic Stimulations of Incremental Intensities in Patients Under Propofol-remifentanil TCI
In patients under standardized steady-state general anesthesia, 6 tetanic stimulations of incremental intensities were applied to the patients. Pupillary dilation in response to these stimulations was recorded.
Read the detailed description
The aim of the study was to investigate a possible correlation between the intensity of a nociceptive stimulus and the magnitude of pupillary reflex dilation in patients anesthetized with propofol and remifentanil target-controlled infusion.
Anesthetic protocol: 10 minutes of steady-state general anesthesia (before extubation during a scheduled gynecological surgery) with remifentanil target concentration of 1 ng/ml, and propofol target concentration adjusted to maintain bispectral index between 45 and 55.
Study period: 6 tetanic stimulations of incremental intensities were applied to the patients: 10, 20, 30, 40, 50, 60 milliamps Pupillary dilation in response to these stimulations was recorded.
Then, propofol and remifentanil infusions were discontinued, and patients were extubated.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesia for scheduled gynecological surgeryProcedure or surgery
PropofolDrug
continuous infusion, target concentration adjusted to maintain bispectral index between 45 and 55
Remifentanil, Ultiva®Drug
continuous infusion, target concentration 1 ng/ml
tetanic stimulationsProcedure or surgery
10-20-30-40-50-60 milliamps, 5 seconds, 100 Hertz 2 minutes between stimulations delivered via the standard neuromuscular blocking agents monitor
VideoAlgesiGraphDevice
Also called VideoAlgesiGraph, Synapsis (TM), Marseille, France
non invasive infrared camera placed in front of the left eye of the patients during the study period, connected to a laptop. No part of the device touches the eye.
| Study group | Role | What they receive |
|---|---|---|
| pupillometry | Experimental | General anesthesia for scheduled gynecological surgery Propofol target concentration adjusted to maintain bispectral index between 45 and 55 for 10 minutes Remifentanil target concentration 1 ng/ml for 10 minutes Tetanic stimulations of 10-20-30-40-50-60 milliamps (5 seconds per stimulation, 2 minutes between stimulations) Continuous pupillometry VideoAlgesiGraph Receives: Procedure: general anesthesia for scheduled gynecological surgery; Drug: Propofol; Drug: Remifentanil, Ultiva®; Procedure: tetanic stimulations; Device: VideoAlgesiGraph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupillary diameter
as measured by VideoAlgesiGraph, in mm
Measured: 5 seconds before tetanic stimulation
Pupillary diameter
as measured by VideoAlgesiGraph, in mm
Measured: 1 minute after tetanic stimulation
Secondary outcomes (2)
Heart rate
as measured by the standard cardioscope
Measured: 5 seconds before tetanic stimulation
Heart rate
as measured by the standard cardioscope
Measured: 1 minute after tetanic stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study startJan 2012
- Primary completionNov 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pr Isabelle CONSTANT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pr Isabelle CONSTANT, Hôpital Armand Trousseau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465773
- Sponsor's protocol ID
- Pupillo propofol remi stim
- Status last verified
- Jul 2020
- First submitted
- 12 Jan 2016
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pupillary Diameter Variations in Response to Tetanic Stimulations of Incremental Intensities in Patients Under Propofol-remifentanil TCI
- ClinicalTrials.gov ID
- NCT04465773
- Acronym / sponsor ID
- Pupillo propofol remi stim
- Conditions
- Pain
- Keywords
- general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Pr Isabelle CONSTANTUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Jul 2020 (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.
In patients under standardized steady-state general anesthesia, 6 tetanic stimulations of incremental intensities were applied to the patients. Pupillary dilation in response to these stimulations was recorded.
Detailed description
The aim of the study was to investigate a possible correlation between the intensity of a nociceptive stimulus and the magnitude of pupillary reflex dilation in patients anesthetized with propofol and remifentanil target-controlled infusion.
Anesthetic protocol: 10 minutes of steady-state general anesthesia (before extubation during a scheduled gynecological surgery) with remifentanil target concentration of 1 ng/ml, and propofol target concentration adjusted to maintain bispectral index between 45 and 55.
Study period: 6 tetanic stimulations of incremental intensities were applied to the patients: 10, 20, 30, 40, 50, 60 milliamps Pupillary dilation in response to these stimulations was recorded.
Then, propofol and remifentanil infusions were discontinued, and patients were extubated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pupillometry | Experimental | Procedure: general anesthesia for scheduled gynecological surgery, Drug: Propofol, Drug: Remifentanil, Ultiva®, Procedure: tetanic stimulations, Device: VideoAlgesiGraphGeneral anesthesia for scheduled gynecological surgery Propofol target concentration adjusted to maintain bispectral index between 45 and 55 for 10 minutes Remifentanil target concentration 1 ng/ml for 10 minutes Tetanic stimulations of 10-20-30-40-50-60 milliamps (5 seconds per stimulation, 2 minutes between stimulations) Continuous pupillometry VideoAlgesiGraph |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled gynecological surgery requiring general anesthesia and orotracheal intubation
- written informed consent
Key exclusion criteria (4 listed)
- ophthalmic disease
- neurologic disease
- preoperative chronic pain or pain medication
- medication interfering with autonomous nervous system (beta blockers, alpha agonists, metoclopramide, droperidol, atropine, catecholamines)
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 |
|---|---|---|
| general anesthesia for scheduled gynecological surgery | Procedure or surgery | pupillometry |
| Propofolcontinuous infusion, target concentration adjusted to maintain bispectral index between 45 and 55 | Drug | pupillometry |
| Remifentanil, Ultiva®continuous infusion, target concentration 1 ng/ml | Drug | pupillometry |
| tetanic stimulations10-20-30-40-50-60 milliamps, 5 seconds, 100 Hertz 2 minutes between stimulations delivered via the standard neuromuscular blocking agents monitor | Procedure or surgery | pupillometry |
| VideoAlgesiGraphAlso: VideoAlgesiGraph, Synapsis (TM), Marseille, Francenon invasive infrared camera placed in front of the left eye of the patients during the study period, connected to a laptop. No part of the device touches the eye. | Device | pupillometry |
Primary outcome
Pupillary diameter
Time frame: 5 seconds before tetanic stimulation
as measured by VideoAlgesiGraph, in mm
Pupillary diameter
Time frame: 1 minute after tetanic stimulation
as measured by VideoAlgesiGraph, in mm
2 secondary outcomes
Heart rate
Time frame: 5 seconds before tetanic stimulation
Heart rate
Time frame: 1 minute after tetanic stimulation
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 10 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing general anesthesia for scheduled gynecological surgery, Propofol and Remifentanil, Ultiva® in people with Pain, run by Pr Isabelle CONSTANT 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 2 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 10 Jul 2020. 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?
Pupillary diameter (time frame: 5 seconds before tetanic stimulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2020.