AnesthesiaNCT02683837
Pupillometry Guided Remifentanil Administration In Pediatric Anesthesia
A study testing Remifentanil, Pupillometry and Sevoflurane in people with Anesthesia and Pain, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The aim of this prospective randomized study is to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in pediatric anesthesia. All patients are anesthetized with sevoflurane and remifentanil. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Anesthesia, Pain, Child
- What is being tested?
- Remifentanil, Pupillometry and Sevoflurane
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2016to Dec 2022
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children scheduled for a surgery lasting more than 90 minutes.
Who cannot join
- Contraindication to sevoflurane, to remifentanil or to morphine.
- Peripheral or central nerve block during and after surgery.
- Ophthalmological disease.
- Peroperative position with no acess to the head.
- Chronic use of medication interfering with pupillary diameter.
- Ambulatory surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Study Evaluating Pupillometry Guided Remifentanil Administration in Pediatric Anesthesia
The aim of this prospective randomized study is to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in pediatric anesthesia. All patients are anesthetized with sevoflurane and remifentanil. In the intervention group, peroperative remifentanil infusion rate is guided by pupillometry. In the other group, remifentanil infusion rate is guided according to hemodynamic data.
- Conditions
- Anesthesia, Pain, Child
- Being tested
- Remifentanil, Pupillometry, Sevoflurane
- Keywords
- Intraoperative Neurophysiological Monitoring, Reflex, Pupillary, remifentanil
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
PupillometryDevice
Pupillary diameter measured every 5 minutes
SevofluraneDrug
Administered to maintain a Bispectral Index between 40 and 60
| Study group | Role | What they receive |
|---|---|---|
| Standard practice | Active comparator | Remifentanil infusion guided by usual clinical signs (heart rate, blood pressure).
Pupillometry blindly recorded. Anesthesia maintenance with sevoflurane. Receives: Drug: Remifentanil; Drug: Sevoflurane |
| Pupillometry | Experimental | Remifentanil infusion guided by changes in pupillary diameter. Anesthesia maintenance with sevoflurane. Receives: Drug: Remifentanil; Device: Pupillometry; Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
peroperative remifentanil consumption
Measured: duration of surgery
Secondary outcomes (4)
Morphine consumption
Measured: during the 24 hour post operative period
Incidence of morphine side effects
Sedation, nausea, vomiting, pruritus, urinary retention
Measured: during the 24 hour post operative period
Pain scoring (verbal numerical scale)
Measured: during the 24 hour post operative period
Pain scoring (questionnaire)
Measured: one month post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2016
- Study completionDec 2022 (estimated)
Why it stopped: Principal investigator left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid HABRE, University Hospital, Geneva
- Investigators
- Walid Habre, MD, PhD, Study director, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683837
- Sponsor's protocol ID
- Pupilloped
- Status last verified
- Apr 2024
- First submitted
- 19 Jan 2016
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study Evaluating Pupillometry Guided Remifentanil Administration in Pediatric Anesthesia
- ClinicalTrials.gov ID
- NCT02683837
- Acronym / sponsor ID
- Pupilloped
- Conditions
- Anesthesia, Pain, Child
- Keywords
- Intraoperative Neurophysiological Monitoring, Reflex, Pupillary, remifentanil
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal investigator left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Feb 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.
The aim of this prospective randomized study is to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in pediatric anesthesia. All patients are anesthetized with sevoflurane and remifentanil. In the intervention group, peroperative remifentanil infusion rate is guided by pupillometry. In the other group, remifentanil infusion rate is guided according to hemodynamic data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard practice | Active comparator | Drug: Remifentanil, Drug: SevofluraneRemifentanil infusion guided by usual clinical signs (heart rate, blood pressure). Pupillometry blindly recorded. Anesthesia maintenance with sevoflurane. |
| Pupillometry | Experimental | Drug: Remifentanil, Device: Pupillometry, Drug: SevofluraneRemifentanil infusion guided by changes in pupillary diameter. Anesthesia maintenance with sevoflurane. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children scheduled for a surgery lasting more than 90 minutes.
Key exclusion criteria (6 listed)
- Contraindication to sevoflurane, to remifentanil or to morphine.
- Peripheral or central nerve block during and after surgery.
- Ophthalmological disease.
- Peroperative position with no acess to the head.
- Chronic use of medication interfering with pupillary diameter.
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 | Pupillometry, Standard practice |
| PupillometryPupillary diameter measured every 5 minutes | Device | Pupillometry |
| SevofluraneAdministered to maintain a Bispectral Index between 40 and 60 | Drug | Pupillometry, Standard practice |
Primary outcome
peroperative remifentanil consumption
Time frame: duration of surgery
4 secondary outcomes
Morphine consumption
Time frame: during the 24 hour post operative period
Incidence of morphine side effects
Time frame: during the 24 hour post operative period
Pain scoring (verbal numerical scale)
Time frame: during the 24 hour post operative period
Pain scoring (questionnaire)
Time frame: one month post-operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- 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.
Walid Habre, MD, PhD study director
University of Geneva, Switzerland
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, Pupillometry and Sevoflurane in people with Anesthesia and Pain, run by University Hospital, Geneva at 1 site in Switzerland.
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 1 inclusion and 6 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: withdrawn, as of the sponsor's last update on 18 Apr 2024. 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 Switzerland. 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 was withdrawn before enrolling participants, so there are no results.
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 (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 18 Apr 2024.