PainNCT02576600
Pupillometry Guided Remifentanil Administration and Total Opioid Consumption During Propofol - Remifentanil TCI
A study testing Videopupillometer Algiscan, Standard practice and Propofol in people with Pain, run by Pr Isabelle CONSTANT at 1 site in France.
Trial summary
The aim of this prospective randomized study was to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in major gynecological surgery. All patients were anesthetized with TCI of propofol and remifentanil. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Videopupillometer Algiscan, Standard practice and Propofol
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Apr 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II
- Elective gynecological surgery
- No ophtalmologic or neurologic disease
- No chronic analgesic medication
- Expected length of surgery 60 minutes minimum
Who cannot join
- ophtalmologic or neurologic disease
- chronic analgesic medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pupillometry Guided Versus Standard Practice Remifentanil Administration and Total Opioid Consumption
The aim of this prospective randomized study was to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in major gynecological surgery. All patients were anesthetized with TCI of propofol and remifentanil. In the intervention group, peroperative remifentanil target was guided by pupillometry. In the other group, remifentanil was administered according to standard practice.
- Conditions
- Pain
- Being tested
- Videopupillometer Algiscan, Standard practice, Propofol, Remifentanil
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videopupillometer AlgiscanDevice
pupillary diameter measurement every five minutes per-operatively
Standard practiceOther
remifentanil administration left to the discretion of the anesthesiologist in charge according to standard practice
PropofolDrug
TCI
RemifentanilDrug
TCI
| Study group | Role | What they receive |
|---|---|---|
| PUPILLO | Experimental | Videopupillometer Algiscan peroperative remifentanil target concentration adapted every five minutes to pupillary diameter in patients under propofol and remifentanil TCI Receives: Device: Videopupillometer Algiscan; Drug: Propofol; Drug: Remifentanil |
| STANDARD | Sham comparator | peroperative remifentanil target concentration as standard practice in patients under propofol and remifentanil TCI Receives: Other: Standard practice; Drug: Propofol; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
peroperative remifentanil consumption in µg/kg/min
Measured: duration of surgery
Secondary outcomes (2)
post-operative morphine requirements in mg/kg
includes initial morphine titration and subsequent PCA use
Measured: 24 hours
peroperative propofol consumption in mg/kg/h
Measured: duration of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startOct 2010
- Primary completionDec 2012
- Study completionApr 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 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
- Investigators
- Isabelle Constant, MD-PHD, Study director, Hôpital Armand Trousseau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576600
- Sponsor's protocol ID
- Anesthesie Trousseau 001
- Status last verified
- Oct 2015
- First submitted
- 13 Oct 2015
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pupillometry Guided Versus Standard Practice Remifentanil Administration and Total Opioid Consumption
- ClinicalTrials.gov ID
- NCT02576600
- Acronym / sponsor ID
- Anesthesie Trousseau 001
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Pr Isabelle CONSTANTUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 Oct 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.
The aim of this prospective randomized study was to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in major gynecological surgery. All patients were anesthetized with TCI of propofol and remifentanil. In the intervention group, peroperative remifentanil target was guided by pupillometry. In the other group, remifentanil was administered according to standard practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PUPILLO | Experimental | Device: Videopupillometer Algiscan, Drug: Propofol, Drug: RemifentanilVideopupillometer Algiscan peroperative remifentanil target concentration adapted every five minutes to pupillary diameter in patients under propofol and remifentanil TCI |
| STANDARD | Sham comparator | Other: Standard practice, Drug: Propofol, Drug: Remifentanilperoperative remifentanil target concentration as standard practice in patients under propofol and remifentanil TCI |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ASA I-II
- Elective gynecological surgery
- No ophtalmologic or neurologic disease
- No chronic analgesic medication
- Expected length of surgery 60 minutes minimum
Key exclusion criteria (2 listed)
- ophtalmologic or neurologic disease
- chronic analgesic medication
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 |
|---|---|---|
| Videopupillometer Algiscanpupillary diameter measurement every five minutes per-operatively | Device | PUPILLO |
| Standard practiceremifentanil administration left to the discretion of the anesthesiologist in charge according to standard practice | Other | STANDARD |
| PropofolTCI | Drug | PUPILLO, STANDARD |
| RemifentanilTCI | Drug | PUPILLO, STANDARD |
Primary outcome
peroperative remifentanil consumption in µg/kg/min
Time frame: duration of surgery
2 secondary outcomes
post-operative morphine requirements in mg/kg
Time frame: 24 hours
peroperative propofol consumption in mg/kg/h
Time frame: duration of 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 19 Oct 2015.
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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
Hôpital 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 Videopupillometer Algiscan, Standard practice and Propofol 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 5 inclusion and 2 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 19 Oct 2015. 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. Some participants in this study may receive a placebo. 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?
peroperative remifentanil consumption in µg/kg/min (time frame: duration of surgery). 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 19 Oct 2015.