AnesthesiaNCT02998424
Pupillary Diameter Under Different Concentrations of Propofol
A study testing Propofol and Pupillary diameter measurement in people with Anesthesia, run by Hôpital Armand Trousseau at 1 site in France.
Trial summary
Resting pupillary diameter was measured at a randomized Effect-site target concentration of propofol used as a sole anesthetic. Read more about this study
- Who is it for?
- Ages 13 to 50 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Propofol and Pupillary diameter measurement
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Dec 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 13 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patient who has reached puberty
- ASA I or II who is scheduled for elective surgery under general anesthesia
Who cannot join
- neurologic, metabolic, ocular disease
- chronic pain
- under medication that interferes with autonomic nervous system
- obesity
- patient requiering a rapid sequence induction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pupillary Diameter Without Stimulation Under Different Concentrations of Propofol Alone
Resting pupillary diameter was measured at a randomized Effect-site target concentration of propofol used as a sole anesthetic.
- Conditions
- Anesthesia
- Being tested
- Propofol, Pupillary diameter measurement
- Keywords
- propofol, pupillary diameter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Continuous infusion
Pupillary diameter measurementDevice
Instantaneous measure
| Study group | Role | What they receive |
|---|---|---|
| Propofol 1 µg/ml | Experimental | Patients received a propofol infusion at an effect-site concentration of 1 µg/ml at the beginning of induction of general anesthesia for elective surgery.
Pupillary diameter measurement after 10 minutes. Receives: Drug: Propofol; Device: Pupillary diameter measurement |
| Propofol 2 µg/ml | Experimental | Patients received a propofol infusion at an effect-site concentration of 2 µg/ml at the beginning of induction of general anesthesia for elective surgery.
Pupillary diameter measurement after 10 minutes. Receives: Drug: Propofol; Device: Pupillary diameter measurement |
| Propofol 3 µg/ml | Experimental | Patients received a propofol infusion at an effect-site concentration of 3 µg/ml at the beginning of induction of general anesthesia for elective surgery.
Pupillary diameter measurement after 10 minutes. Receives: Drug: Propofol; Device: Pupillary diameter measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupillary diameter
Measured: Instantaneous measure, 10 minutes after the beginning of the study period
Secondary outcomes (3)
Bispectral Index (BIS)
Measured: continuous measure, recorded10 minutes after the beginning of the study period
Heart rate
Measured: continuous measure, recorded10 minutes after the beginning of the study period
Observer's Assessment of Alertness/Sedation Scale (OAAS)
Clinical score
Measured: 10 minutes after the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016
- Study completionDec 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 AnesthesiaStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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, Université Paris 6, Département d'anesthésie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998424
- Sponsor's protocol ID
- PD and propofol
- Status last verified
- Jun 2018
- First submitted
- 13 Dec 2016
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sabourdin N, Meniolle F, Chemam S, Rigouzzo A, Hamza J, Louvet N, Constant I. Effect of Different Concentrations of Propofol Used as a Sole Anesthetic on Pupillary Diameter: A Randomized Trial. Anesth Analg. 2020 Aug;131(2):510-517. doi: 10.1213/ANE.0000000000004362.
PubMed 31490817
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pupillary Diameter Without Stimulation Under Different Concentrations of Propofol Alone
- ClinicalTrials.gov ID
- NCT02998424
- Acronym / sponsor ID
- PD and propofol
- Conditions
- Anesthesia
- Keywords
- propofol, pupillary diameter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hôpital Armand TrousseauUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Dec 2016 (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.
Resting pupillary diameter was measured at a randomized Effect-site target concentration of propofol used as a sole anesthetic.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propofol 1 µg/ml | Experimental | Drug: Propofol, Device: Pupillary diameter measurementPatients received a propofol infusion at an effect-site concentration of 1 µg/ml at the beginning of induction of general anesthesia for elective surgery. Pupillary diameter measurement after 10 minutes. |
| Propofol 2 µg/ml | Experimental | Drug: Propofol, Device: Pupillary diameter measurementPatients received a propofol infusion at an effect-site concentration of 2 µg/ml at the beginning of induction of general anesthesia for elective surgery. Pupillary diameter measurement after 10 minutes. |
| Propofol 3 µg/ml | Experimental | Drug: Propofol, Device: Pupillary diameter measurementPatients received a propofol infusion at an effect-site concentration of 3 µg/ml at the beginning of induction of general anesthesia for elective surgery. Pupillary diameter measurement after 10 minutes. |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patient who has reached puberty
- ASA I or II who is scheduled for elective surgery under general anesthesia
Key exclusion criteria (5 listed)
- neurologic, metabolic, ocular disease
- chronic pain
- under medication that interferes with autonomic nervous system
- obesity
- patient requiering a rapid sequence induction
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 |
|---|---|---|
| PropofolContinuous infusion | Drug | Propofol 1 µg/ml, Propofol 2 µg/ml, Propofol 3 µg/ml |
| Pupillary diameter measurementInstantaneous measure | Device | Propofol 1 µg/ml, Propofol 2 µg/ml, Propofol 3 µg/ml |
Primary outcome
Pupillary diameter
Time frame: Instantaneous measure, 10 minutes after the beginning of the study period
3 secondary outcomes
Bispectral Index (BIS)
Time frame: continuous measure, recorded10 minutes after the beginning of the study period
Heart rate
Time frame: continuous measure, recorded10 minutes after the beginning of the study period
Observer's Assessment of Alertness/Sedation Scale (OAAS)
Time frame: 10 minutes after the beginning of the study
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 26 Jun 2018.
- Derived from this study: PubMed 31490817Sabourdin N, Meniolle F, Chemam S, Rigouzzo A, Hamza J, Louvet N, Constant I. Effect of Different Concentrations of Propofol Used as a Sole Anesthetic on Pupillary Diameter: A Randomized Trial. Anesth Analg. 2020 Aug;131(2):510-517. doi: 10.1213/ANE.0000000000004362.
- 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.
Isabelle Constant, MD-PHD study director
Hopital Armand Trousseau, Université Paris 6, Département d'anesthésie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Pupillary diameter measurement in people with Anesthesia, 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 5 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 26 Jun 2018. 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: Instantaneous measure, 10 minutes after the beginning of the study period). 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 NCT02998424, 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 26 Jun 2018.