Pupillary Dilation Reflex Assessment for Intraoperative Analgesic Titration. (PUP-AIT)

Antwerp University Hospital (UZA)

Status: Completed

Conditions: Pain, Acute; Anesthesia

Treatments: Other: Standard of care; Diagnostic Test: Pupillary dilation reflex

Study type: Interventional

Funder types: Other

Identifiers

NCT03248908

17/28/319

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 4 patient groups

Intervention 1

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Pupillary dilation reflex

Intervention 2

Active Comparator group

Description:

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.

Treatment:

Other: Standard of care

Intervention 3

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Pupillary dilation reflex

Intervention 4

Active Comparator group

Description:

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.

Treatment:

Other: Standard of care