Pupillary Dilation Reflex Assessment for Intraoperative Analgesic Titration.

Anesthesia Clinical Trial

— PUP-AIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248908
• Other study ID #: 17/28/319
• Status: Completed
• Phase: N/A
• Start date: October 12, 2017
• Est. completion date: January 31, 2022

Study information

• Verified date: May 2023
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 31, 2022
• Est. primary completion date: September 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Anesthesia
• Mydriasis
• Pain, Acute

Intervention

Diagnostic Test:
• 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

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

Locations

Country	Name	City	State
Belgium	University hospital Antwerp	Edegem	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Numeric rating scale (NRS) pain assessment	From patient extubation until postoperative day 5
Primary	Postoperative analgesia	Analgetic consumption	From patient extubation until postoperative day 5
Secondary	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
Secondary	Baseline pupil diameter	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Postoperative nausea and vomiting	Frequency of nausea or vomiting after surgery, in numbers of events	From patient extubation until postoperative day 5
Secondary	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
Secondary	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
Secondary	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