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Completed

NCT Number: NCT03248908

Pupillary Dilation Reflex Assessment for Intraoperative Analgesic Titration.

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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Key information

Conditions

Pain, Acute Acute Pain Anesthesia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Antwerp

Edegem, Antwerp, 2650, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Standard of care

Other

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

Primary outcomes

  1. Postoperative pain

    Time frame: From patient extubation until postoperative day 5

    Numeric rating scale (NRS) pain assessment

  2. Postoperative analgesia

    Time frame: From patient extubation until postoperative day 5

    Analgetic consumption

Secondary outcomes

  1. Stimulation intensity to elicit PDR

    Time frame: 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

    Necessary stimulation intensity generated by the pupillometer to elicit a PDR

  2. Baseline pupil diameter

    Time frame: 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

    Pupil size before stimulation

  3. Pupillary dilation reflex amplitude

    Time frame: 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

    The amplitude of the pupil enlargement after nociceptive stimulation

  4. Pupillary pain index (PPI)

    Time frame: 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

    Generated PPI score by the pupillometer in accordance to given stimulation and pupillary dilation reflex amplitude

  5. Opioid usage during surgery

    Time frame: 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

    Total dose remifentanil or sufentanil administrated during surgery, in microgram

  6. Extubation time

    Time frame: From the day of surgery at the termination of propofol infusion until patient extubation, assessed up to 2 hours

    The time between stop of propofol administration and patient extubation, in minutes

  7. Postoperative nausea and vomiting

    Time frame: From patient extubation until postoperative day 5

    Frequency of nausea or vomiting after surgery, in numbers of events

  8. Length of stay at the postanesthesia care unit

    Time frame: From admission at the postanesthesia care unit until discharge to the nursing ward, assessed up to 24 hours

    Hours of admission at the postanesthesia care unit after surgery until discharge to the nursing ward, in minutes

  9. Length of hospital stay

    Time frame: From the day of the planned surgery until hospital discharge, assessed up to 5 days

    Length of hospital stay, in days

  10. Postoperative health status

    Time frame: From extubation until 1 month after surgery

    Assessed by 5-level EQ-5D version (EQ-5D-5L), quality of life and health status questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Universiteit Antwerpen

Registry information

Official study title

Pupillary Dilation Reflex Assessment for Intraoperative Analgesic Titration [PUP-AIT]. A Double Blinded Randomized Trial.

Acronym: PUP-AIT

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Aug 15, 2017
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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