Pupillary Dilation Reflex Assessment for Intraoperative Analgesic Titration.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-12

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain, Acute Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blinded randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

The patient, the performer of the pupillary reflex measurement, and the postoperative health care provider are masked for the study arms.

Study Groups

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Intervention 1

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.

Group Type EXPERIMENTAL

Pupillary dilation reflex

Intervention Type 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

Intervention 2

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.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

Perioperative opioid administration based on the attending anesthesiologist decision (mainly including assessment of heart rate, blood pressure, and limb movement)

Intervention 3

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.

Group Type EXPERIMENTAL

Pupillary dilation reflex

Intervention Type 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

Intervention 4

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.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

Perioperative opioid administration based on the attending anesthesiologist decision (mainly including assessment of heart rate, blood pressure, and limb movement)

Interventions

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Pupillary dilation reflex

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

Intervention Type DIAGNOSTIC_TEST

Standard of care

Perioperative opioid administration based on the attending anesthesiologist decision (mainly including assessment of heart rate, blood pressure, and limb movement)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No