Monitoring Pupillary Reflex Dilatation for Optimized Postoperative Opioid Delivery Before Extubation.
NCT ID: NCT04594382
Last Updated: 2023-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
140 participants
INTERVENTIONAL
2020-10-21
2023-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious
NCT04000126
Pupillary Dilation Reflex Assessment for Intraoperative Analgesic Titration.
NCT03248908
Atropine-effect During Propofol/Remifentanil Induction
NCT01871922
Opioid-based Versus Opioid-free Endotracheal Intubation
NCT06464393
Pupillometry Guided Remifentanil Administration and Total Opioid Consumption During Propofol - Remifentanil TCI
NCT02576600
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
T30/60
Before extubation, opioid administration will be given by a single dose of opioids in case of measured PDR values of ≥12.
Pupillometry-Opioid treatment
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.
Non-T30/60
A standardized single dose of opioid will be given intravenously before extubation, regardless of the measured pupillometry PDR values.
Pupillometry -standardized opioid treatment
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.
Standard Care group
The amount of administered piritramid in the OR will be left to the discretion of the anesthesiologist attending the participant.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pupillometry-Opioid treatment
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 treatment
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Vienna
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marita Windpassinger M.D.
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University Vienna
Vienna, , Austria
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2063/2020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.