Postoperative PainNCT04594382
Monitoring Pupillary Reflex Dilatation for Optimized Postoperative Opioid Delivery Before Extubation.
A study testing Pupillometry-Opioid treatment and Pupillometry -standardized opioid treatment in people with Postoperative Pain, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The study will be designed to investigate the effect of pupillometry guided compared to non-PPI-guided postoperative pain therapy, conducted immediately at the end of surgery before extubation, on total postoperative opioid consumption during the first 2 postoperative hours after elective ear nose throat (ENT) surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Pupillometry-Opioid treatment and Pupillometry -standardized opioid treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteAustria
- Study dates
- 21 Oct 2020to 31 Jul 2023
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology (ASA) physical status I-II
- able to read and understand the information sheet and to sign the consent form
- being scheduled for elective ENT surgery under general anesthesia
- age≥18 years
Who cannot join
- ASA physical status of III and above
- previous history of either drug or alcohol abuse
- difficulty to understand pain scoring system
- chronic users of analgesics or had used opioids within 12 h before surgery
- drug or alcohol abuse
- contraindications for metamizole
Show all 14Show fewer
- preoperative topical eye medication (atropine, phenylephrine), preoperative pupil abnormality
- concomitant treatment with beta-antagonists, metoclopramide or droperidol
- implanted electronic medical devices
- dysfunction of the autonomic nervous system in relation to advanced diabetes mellitus
- ophthalmologic diseases, known pupil reflex disorders, cranial nerve lesions
- rapid sequence induction (RSI)
- neurological, psychiatric or mental disorders
- surgical procedure warranting elective postoperative ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring Pupillary Reflex Dilatation for Optimized Postoperative Opioid Delivery Before Extubation: A Randomized Pupillometry Study
The study will be designed to investigate the effect of pupillometry guided compared to non-PPI-guided postoperative pain therapy, conducted immediately at the end of surgery before extubation, on total postoperative opioid consumption during the first 2 postoperative hours after elective ear nose throat (ENT) surgery.
Read the detailed description
Pupillometric pain measurements helps clinicians determine and administer the optimized amount of opioids and so avoids opioid-induced side effects.The study will be designed to investigate the effect of pupillometry guided compared to non-PPI-guided postoperative pain therapy, conducted before extubation, on total postoperative opioid consumption during the first 2 postoperative hours after elective ENT surgery.
Background The evaluation of pain intensity during the immediate postoperative period in the operating room (OR) is a key factor for post interventional pain treatment. However, this evaluation may be difficult when patients are still intubated, restricted in consciousness or are showing verbal impairment due to ENT surgery. Verbally impaired patients are at increased risk of under treatment for pain.
With rising opioid consumption, the risk of postoperative side effects like nausea and vomiting, sedation with a longer recovery time or respiratory depression increases. Especially in the cohort of ENT surgery patients, where a difficult airway is regularly presented, such side effects should be avoided. A means of predicting immediate postoperative pain after surgery and the response to opiate analgesics would therefore be highly desirable.
The pupillary dilatation reflex (PDR), measured by pupillometry, has been successfully used to assess intraoperative analgesic component of anesthetic regimes and correlates with pain intensity measured on a numeric rating scale (NRS).
Aims
Primary aim of this study is to investigate if a pupillometry-guided opioid administration immediately postoperative in the OR leads to less opioid requirement during the first 2 postoperative hours compared to a non-pupillometry-guided treatment.
Secondary aim is to evaluate postoperative pain intensity during the first 2 postoperative hours in patients after pupillometry-guided versus non-pupillometry -guided opioid therapy in the OR.
Hypotheses
The investigators hypothesis that through a targeted pain therapy based on the measurement of immediate postoperative pupillometry scores, opioid consumption and pain intensity can be reduced during the first 2 postoperative hours.
Methods
The study will be done by observing postoperative pain intensity using pupillometry in patients scheduled for elective ENT surgery, carrying out pain intervention (opioid therapy) and re-observing to verify the effectiveness of the targeted postoperative opioid administration in the OR. Pain on an 11-point verbal Likert response score and total opioid consumption will be recorded by a blinded investigator at 30-minute intervals for the initial 2 postoperative hours.
- Conditions
- Postoperative Pain
- Being tested
- Pupillometry-Opioid treatment, Pupillometry -standardized opioid treatment
- Keywords
- Postoperative Pain, Infrared Pupillometry, Postoperative Opioid Consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pupillometry-Opioid treatmentDiagnostic test
At the end of anesthesia, before extubation, pupillometry measurements will be performed on both eyes, using the tetanus mode T30 (30mA tetanic stimulation) and T60 (60mA tetanic stimulation) and the standardized pupillary pain index (PPI) mode at the pupillometer.
Opioid administration will be given by a single dose of piritramid (0.1 mg kg -1) in case of measured PDR values of ≥12 (high analgesic sensitivity as specified by the producer) after T30 and T60 stimulation. The pupillometry measurement will be repeated once on both eyes.
Pupillometry -standardized opioid treatmentDiagnostic test
At the end of anesthesia, before extubation, pupillometry measurements will be performed on both eyes, using the tetanus mode T30 (30mA tetanic stimulation) and T60 (60mA tetanic stimulation) and the standardized pupillary pain index (PPI) mode at the pupillometer.
A standardized single dose of piritramid (0,1 mg kg -1) will be given intravenously, regardless of the measured values. The pupillometry measurement will be repeated once on both eyes.
| Study group | Role | What they receive |
|---|---|---|
| T30/60 | Active comparator | Before extubation, opioid administration will be given by a single dose of opioids in case of measured PDR values of ≥12. Receives: Diagnostic Test: Pupillometry-Opioid treatment |
| Non-T30/60 | Active comparator | A standardized single dose of opioid will be given intravenously before extubation, regardless of the measured pupillometry PDR values. Receives: Diagnostic Test: Pupillometry -standardized opioid treatment |
| Standard Care group | No intervention | The amount of administered piritramid in the OR will be left to the discretion of the anesthesiologist attending the participant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
cumulative opioid consumption within first 2 postoperative hours
Measured: first 2 postoperative hours
Secondary outcomes (1)
postoperative pain intensity
Pain on an 11-point verbal Likert response score (VAS score) recorded by a blinded investigator at 30-minute intervals for the initial 2 postoperative hours. The 11-point numeric scale ranges between 0, meaning no pain, and 10, meaning worst pain.
Measured: first 2 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start21 Oct 2020
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marita Windpassinger M.D., Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594382
- Sponsor's protocol ID
- 2063/2020
- Status last verified
- Aug 2023
- First submitted
- 13 Oct 2020
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Pupillary Reflex Dilatation for Optimized Postoperative Opioid Delivery Before Extubation: A Randomized Pupillometry Study
- ClinicalTrials.gov ID
- NCT04594382
- Acronym / sponsor ID
- 2063/2020
- Conditions
- Postoperative Pain
- Keywords
- Postoperative Pain, Infrared Pupillometry, Postoperative Opioid Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 20 Oct 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.
The study will be designed to investigate the effect of pupillometry guided compared to non-PPI-guided postoperative pain therapy, conducted immediately at the end of surgery before extubation, on total postoperative opioid consumption during the first 2 postoperative hours after elective ear nose throat (ENT) surgery.
Detailed description
Pupillometric pain measurements helps clinicians determine and administer the optimized amount of opioids and so avoids opioid-induced side effects.The study will be designed to investigate the effect of pupillometry guided compared to non-PPI-guided postoperative pain therapy, conducted before extubation, on total postoperative opioid consumption during the first 2 postoperative hours after elective ENT surgery.
Background The evaluation of pain intensity during the immediate postoperative period in the operating room (OR) is a key factor for post interventional pain treatment. However, this evaluation may be difficult when patients are still intubated, restricted in consciousness or are showing verbal impairment due to ENT surgery. Verbally impaired patients are at increased risk of under treatment for pain.
With rising opioid consumption, the risk of postoperative side effects like nausea and vomiting, sedation with a longer recovery time or respiratory depression increases. Especially in the cohort of ENT surgery patients, where a difficult airway is regularly presented, such side effects should be avoided. A means of predicting immediate postoperative pain after surgery and the response to opiate analgesics would therefore be highly desirable.
The pupillary dilatation reflex (PDR), measured by pupillometry, has been successfully used to assess intraoperative analgesic component of anesthetic regimes and correlates with pain intensity measured on a numeric rating scale (NRS).
Aims
Primary aim of this study is to investigate if a pupillometry-guided opioid administration immediately postoperative in the OR leads to less opioid requirement during the first 2 postoperative hours compared to a non-pupillometry-guided treatment.
Secondary aim is to evaluate postoperative pain intensity during the first 2 postoperative hours in patients after pupillometry-guided versus non-pupillometry -guided opioid therapy in the OR.
Hypotheses
The investigators hypothesis that through a targeted pain therapy based on the measurement of immediate postoperative pupillometry scores, opioid consumption and pain intensity can be reduced during the first 2 postoperative hours.
Methods
The study will be done by observing postoperative pain intensity using pupillometry in patients scheduled for elective ENT surgery, carrying out pain intervention (opioid therapy) and re-observing to verify the effectiveness of the targeted postoperative opioid administration in the OR. Pain on an 11-point verbal Likert response score and total opioid consumption will be recorded by a blinded investigator at 30-minute intervals for the initial 2 postoperative hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T30/60 | Active comparator | Diagnostic Test: Pupillometry-Opioid treatmentBefore extubation, opioid administration will be given by a single dose of opioids in case of measured PDR values of ≥12. |
| Non-T30/60 | Active comparator | Diagnostic Test: Pupillometry -standardized opioid treatmentA standardized single dose of opioid will be given intravenously before extubation, regardless of the measured pupillometry PDR values. |
| Standard Care group | No intervention | –The amount of administered piritramid in the OR will be left to the discretion of the anesthesiologist attending the participant. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiology (ASA) physical status I-II
- able to read and understand the information sheet and to sign the consent form
- being scheduled for elective ENT surgery under general anesthesia
- age≥18 years
Key exclusion criteria (14 listed)
- ASA physical status of III and above
- previous history of either drug or alcohol abuse
- difficulty to understand pain scoring system
- chronic users of analgesics or had used opioids within 12 h before surgery
- drug or alcohol abuse
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 |
|---|---|---|
| Pupillometry-Opioid treatmentAt the end of anesthesia, before extubation, pupillometry measurements will be performed on both eyes, using the tetanus mode T30 (30mA tetanic stimulation) and T60 (60mA tetanic stimulation) and the standardized pupillary pain index (PPI) mode at the pupillometer. Opioid administration will be given by a single dose of piritramid (0.1 mg kg -1) in case of measured PDR values of ≥12 (high analgesic sensitivity as specified by the producer) after T30 and T60 stimulation. The pupillometry measurement will be repeated once on both eyes. | Diagnostic test | T30/60 |
| Pupillometry -standardized opioid treatmentAt the end of anesthesia, before extubation, pupillometry measurements will be performed on both eyes, using the tetanus mode T30 (30mA tetanic stimulation) and T60 (60mA tetanic stimulation) and the standardized pupillary pain index (PPI) mode at the pupillometer. A standardized single dose of piritramid (0,1 mg kg -1) will be given intravenously, regardless of the measured values. The pupillometry measurement will be repeated once on both eyes. | Diagnostic test | Non-T30/60 |
Primary outcome
Opioid consumption
Time frame: first 2 postoperative hours
cumulative opioid consumption within first 2 postoperative hours
1 secondary outcome
postoperative pain intensity
Time frame: first 2 postoperative hours
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 30 Aug 2023.
- 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.
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 Pupillometry-Opioid treatment and Pupillometry -standardized opioid treatment in people with Postoperative Pain, run by Medical University of Vienna at 1 site in Austria.
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 4 inclusion and 14 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 30 Aug 2023. 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 Austria. 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?
Opioid consumption (time frame: first 2 postoperative hours). 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 30 Aug 2023.