PainNCT02595476
Influence of Depth of Anesthesia on Pupillary Reactivity to a Standardized Stimulus
A study testing Remifentanil, propofol and TCI in people with Pain, run by Hôpital Armand Trousseau at 1 site in France.
Trial summary
A standardized tetanic stimulation is applied to patients under propofol-remifentanil TCI, in a cross-over fashion, at two different levels of anesthesia monitored by the BIS: BIS 25 and BIS 55. Remifentanil target remains constant during the whole study period (1 ng/ml). Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Pain
- What is being tested?
- Remifentanil, propofol and TCI
- 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
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Mar 2016
- 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 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ASA 1-2
- scheduled for an idiopathic scoliosis surgical correction
Who cannot join
- Ophtalmologic pathology
- Neurologic or muscular pathology
- Metabolic pathology
- Chronic pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Depth of Anesthesia on Pupillary Reactivity to a Standardized Stimulus Under Steady-state Remifentanil Analgesia
A standardized tetanic stimulation is applied to patients under propofol-remifentanil TCI, in a cross-over fashion, at two different levels of anesthesia monitored by the BIS: BIS 25 and BIS 55. Remifentanil target remains constant during the whole study period (1 ng/ml). Pupillary reflex dilation is recorded after each stimulation.
- Conditions
- Pain
- Being tested
- Remifentanil, propofol, TCI, Tetanic stimulation, Algiscan
- Keywords
- analgesia, pupillometry, general anesthesia
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
propofolDrug
TCIDevice
Tetanic stimulationProcedure or surgery
AlgiscanDevice
Pupillometry
| Study group | Role | What they receive |
|---|---|---|
| BIS 55 | Experimental | 1. Induction:
TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg)
2. Orotracheal Intubation
3. Remifentanil target decreased to 1 ng/ml
4. Propofol target adjustment to reach BIS 55
5. 10 minutes steady state
6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds
7. Pupillary dilation recording (videopupillometer Algiscan) Receives: Drug: Remifentanil; Drug: propofol; Device: TCI; Procedure: Tetanic stimulation; Device: Algiscan |
| BIS 25 | Active comparator | 1. Induction:
TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg)
2. Orotracheal Intubation
3. Remifentanil target decreased to 1 ng/ml
4. Propofol target adjustment to reach BIS 25
5. 10 minutes steady state
6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds
7. Pupillary dilation recording (videopupillometer Algiscan) Receives: Drug: Remifentanil; Drug: propofol; Device: TCI; Procedure: Tetanic stimulation; Device: Algiscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-stimulation Pupillary reflex dilation
percentage of dilation compared to pre-stimulation pupillary diameter
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionMar 2016
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 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Armand Trousseau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Isabelle CONSTANT, Hôpital Armand Trousseau
- Investigators
- Isabelle Constant, MD, PHD, Study director, Hopital Armand Trousseau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595476
- Sponsor's protocol ID
- Anesthésie Trousseau 002
- Status last verified
- Mar 2017
- First submitted
- 2 Nov 2015
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Sabourdin N, Peretout JB, Khalil E, Guye ML, Louvet N, Constant I. Influence of Depth of Hypnosis on Pupillary Reactivity to a Standardized Tetanic Stimulus in Patients Under Propofol-Remifentanil Target-Controlled Infusion: A Crossover Randomized Pilot Study. Anesth Analg. 2018 Jan;126(1):70-77. doi: 10.1213/ANE.0000000000001802.
PubMed 28107273
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Depth of Anesthesia on Pupillary Reactivity to a Standardized Stimulus Under Steady-state Remifentanil Analgesia
- ClinicalTrials.gov ID
- NCT02595476
- Acronym / sponsor ID
- Anesthésie Trousseau 002
- Conditions
- Pain
- Keywords
- analgesia, pupillometry, general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hôpital Armand TrousseauUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 3 Nov 2015 (estimated)
- 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.
A standardized tetanic stimulation is applied to patients under propofol-remifentanil TCI, in a cross-over fashion, at two different levels of anesthesia monitored by the BIS: BIS 25 and BIS 55. Remifentanil target remains constant during the whole study period (1 ng/ml). Pupillary reflex dilation is recorded after each stimulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIS 55 | Experimental | Drug: Remifentanil, Drug: propofol, Device: TCI, Procedure: Tetanic stimulation, Device: Algiscan1. Induction: TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg) 2. Orotracheal Intubation 3. Remifentanil target decreased to 1 ng/ml 4. Propofol target adjustment to reach BIS 55 5. 10 minutes steady state 6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds 7. Pupillary dilation recording (videopupillometer Algiscan) |
| BIS 25 | Active comparator | Drug: Remifentanil, Drug: propofol, Device: TCI, Procedure: Tetanic stimulation, Device: Algiscan1. Induction: TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg) 2. Orotracheal Intubation 3. Remifentanil target decreased to 1 ng/ml 4. Propofol target adjustment to reach BIS 25 5. 10 minutes steady state 6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds 7. Pupillary dilation recording (videopupillometer Algiscan) |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- ASA 1-2
- scheduled for an idiopathic scoliosis surgical correction
Key exclusion criteria (4 listed)
- Ophtalmologic pathology
- Neurologic or muscular pathology
- Metabolic pathology
- Chronic pain
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 |
|---|---|---|
| Remifentanil | Drug | BIS 25, BIS 55 |
| propofol | Drug | BIS 25, BIS 55 |
| TCI | Device | BIS 25, BIS 55 |
| Tetanic stimulation | Procedure or surgery | BIS 25, BIS 55 |
| AlgiscanPupillometry | Device | BIS 25, BIS 55 |
Primary outcome
Post-stimulation Pupillary reflex dilation
Time frame: 30 seconds
percentage of dilation compared to pre-stimulation pupillary diameter
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 4 Apr 2017.
- Derived from this study: PubMed 28107273Sabourdin N, Peretout JB, Khalil E, Guye ML, Louvet N, Constant I. Influence of Depth of Hypnosis on Pupillary Reactivity to a Standardized Tetanic Stimulus in Patients Under Propofol-Remifentanil Target-Controlled Infusion: A Crossover Randomized Pilot Study. Anesth Analg. 2018 Jan;126(1):70-77. doi: 10.1213/ANE.0000000000001802.
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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.
Isabelle Constant, MD, PHD study director
Hopital Armand Trousseau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil, propofol and TCI in people with Pain, run by Hôpital Armand Trousseau 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 4 Apr 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?
Post-stimulation Pupillary reflex dilation (time frame: 30 seconds). 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 NCT02595476, 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 4 Apr 2017.