Clinical trial NCT03248908: Pupillary Dilation Reflex Assessment for Intraoperative Analgesic Titration.
Official title: Pupillary Dilation Reflex Assessment for Intraoperative Analgesic Titration [PUP-AIT]. A Double Blinded Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Anesthesia
Keywords: pupillary reflex
nociception
heart rate
intraoperative monitoring
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2017-08-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* \> 18 jaar
* Elective abdominal or gynaecological operation
* ASA (American Society of Anesthesiologists classification): I - II - III

Exclusion Criteria:

* History of invasive ophthalmological surgery
* Known bilateral eye disease
* Known optical of oculomotor nerve deficit
* Active psychiatrical disease
* Proven active pheochromocytoma
* Opioid usage \> 7 days preoperative
* Ongoing oncological treatment with chemotherapeutic agents
* Usage of A-1 adrenergic of beta-blocking agents
* Preoperative usage of benzodiazepines
* Topical atropine or phenylephrine (eye droplets)
* Planned perioperative usage of dopamine antagonists

Primary outcomes:
measure: Postoperative pain
timeFrame: From patient extubation until postoperative day 5
measure: Postoperative analgesia
timeFrame: From patient extubation until postoperative day 5
Secondary outcomes:
measure: Stimulation intensity to elicit PDR
timeFrame: 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
measure: Baseline pupil diameter
timeFrame: 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
measure: Pupillary dilation reflex amplitude
timeFrame: 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
measure: Pupillary pain index (PPI)
timeFrame: 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
measure: Opioid usage during surgery
timeFrame: 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
measure: Extubation time
timeFrame: From the day of surgery at the termination of propofol infusion until patient extubation, assessed up to 2 hours
measure: Postoperative nausea and vomiting
timeFrame: From patient extubation until postoperative day 5
measure: Length of stay at the postanesthesia care unit
timeFrame: From admission at the postanesthesia care unit until discharge to the nursing ward, assessed up to 24 hours
measure: Length of hospital stay
timeFrame: From the day of the planned surgery until hospital discharge, assessed up to 5 days
measure: Postoperative health status
timeFrame: From extubation until 1 month after surgery
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University hospital Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Davina Wildemeersch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.