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| Name | Class |
|---|---|
| Universiteit Antwerpen | OTHER |
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In this double blinded randomized controlled study, the pupillary dilation reflex is used for as a nociceptive indicator for opioid administration during elective surgery under general anesthesia.
An infrared camera of the video pupillometer measures the pupillary dilation reflex (PDR) in response of a nociceptive stimulus. This autonomic reflex, parasympathetic mediated in sedated patients, can be generated by various pain stimuli (built in standardized protocol, surgical incision, …) The PDR is a robust reflex, even in patients under general anesthesia, and provides a potential evaluation of the autonomous circuit within the nociceptive evaluation based on pupil dilation upon A-delta and C fibers in both electrical or mechanic stimulation. This double blind randomized controlled trial involving American Society of Anesthesiologists (ASA) classification I-III patients undergoing elective surgery under general anesthesia are recruited. Enrolled patients are randomized in four groups: (1) remifentanil administration depending on PDR results, (2) remifentanil administration depending on decision attending anesthesiologist, (3) sufentanil administration depending on PDR results, (4) sufentanil administration depending on decision attending anesthesiologist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention 1 | Experimental | Pupillary dilation reflex based perioperative intravenous remifentanil administration. Starting dose 5 ng/ml by continous infusion, dosage adjustments are made after pupillary dilation reflex assessment every 10 minutes. When PPI score is 1, the dosage is decreased with 0.2 ng/ml. When PPI score is greater than 1, the dosage is increased with 0.2 ng/ml. |
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| Intervention 2 | Active Comparator | Anesthesiologist based perioperative intravenous remifentanil administration (daily practice, standard of care). Starting dose 5 ng/ml, dosage adjustments are made when deemed necessary by attending anesthesiologist. |
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| Intervention 3 | Experimental | Pupillary dilation reflex based perioperative intravenous sufentanil administration. Starting dose 0.1 mcg/kg bolus, dosage adjustments are made after pupillary dilation reflex assessment every 10 minutes. When PPI score is 1, no supplementary administration is executed. When PPI score is greater than 1, a supplementary bolus of 0.1 mcg/kg is given. |
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| Intervention 4 | Active Comparator | Anesthesiologist based perioperative intravenous sufentanil administration (daily practice, standard of care). Starting dose 0.1 mcg/kg bolus, dosage adjustments are made when deemed necessary by attending anesthesiologist. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pupillary dilation reflex | Diagnostic Test | Perioperative pupillary dilation reflex assessment is executed every 10 minutes from start sedation until extubation in patients allocated to study arm Intervention 1 and Intervention 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Numeric rating scale (NRS) pain assessment | From patient extubation until postoperative day 5 |
| Postoperative analgesia | Analgetic consumption | From patient extubation until postoperative day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Stimulation intensity to elicit PDR | Necessary stimulation intensity generated by the pupillometer to elicit a PDR | From the day of surgery at the start of general anesthesia, assessed every 10 minutes until the end of surgery or extubation, whichever came first, assessed up to 4 hours |
| Baseline pupil diameter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Davina Wildemeersch, MD | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Antwerp | Edegem | Antwerp | 2650 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36189668 | Derived | Vlaenderen DV, Hans G, Saldien V, Wildemeersch D. Pupillary reflex dilation and pain index evaluation during general anesthesia using sufentanil: a double-blind randomized controlled trial. Pain Manag. 2022 Nov;12(8):931-941. doi: 10.2217/pmt-2022-0027. Epub 2022 Oct 3. |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Double blinded randomized controlled trial
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The patient, the performer of the pupillary reflex measurement, and the postoperative health care provider are masked for the study arms.
| Standard of care | Other | Perioperative opioid administration based on the attending anesthesiologist decision (mainly including assessment of heart rate, blood pressure, and limb movement) |
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Pupil size before stimulation |
| From the day of surgery at the start of general anesthesia, assessed every 10 minutes until the end of surgery or extubation, whichever came first, assessed up to 4 hours |
| Pupillary dilation reflex amplitude | The amplitude of the pupil enlargement after nociceptive stimulation | From the day of surgery at the start of general anesthesia, assessed every 10 minutes until the end of surgery or extubation, whichever came first, assessed up to 4 hours |
| Pupillary pain index (PPI) | Generated PPI score by the pupillometer in accordance to given stimulation and pupillary dilation reflex amplitude | From the day of surgery at the start of general anesthesia, assessed every 10 minutes until the end of surgery or extubation, whichever came first, assessed up to 4 hours |
| Opioid usage during surgery | Total dose remifentanil or sufentanil administrated during surgery, in microgram | From the day of surgery at the start of general anesthesia, assessed every 10 minutes until the end of surgery or extubation, whichever came first, assessed up to 4 hours |
| Extubation time | The time between stop of propofol administration and patient extubation, in minutes | From the day of surgery at the termination of propofol infusion until patient extubation, assessed up to 2 hours |
| Postoperative nausea and vomiting | Frequency of nausea or vomiting after surgery, in numbers of events | From patient extubation until postoperative day 5 |
| Length of stay at the postanesthesia care unit | Hours of admission at the postanesthesia care unit after surgery until discharge to the nursing ward, in minutes | From admission at the postanesthesia care unit until discharge to the nursing ward, assessed up to 24 hours |
| Length of hospital stay | Length of hospital stay, in days | From the day of the planned surgery until hospital discharge, assessed up to 5 days |
| Postoperative health status | Assessed by 5-level EQ-5D version (EQ-5D-5L), quality of life and health status questionnaire | From extubation until 1 month after surgery |