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Evaluation of Pupillometry as a Predictor of Pain Intensity Upon Withdrawal of Sedation in the Postoperative Period Following Cardiac Surgery: A Prospective Cohort Study

Evaluation of Pupillometry as a Predictor of Pain Intensity Upon Withdrawal of Sedation in the Postoperative Period Following Cardiac Surgery: A Prospective Cohort Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07648342
Acronym
PUPREA
Enrollment
100
Registered
2026-06-15
Start date
2026-07-01
Completion date
2028-07-01
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Scheduled for Surgery

Brief summary

Postoperative pain is a significant issue following surgery, and pain that is either inadequately treated or, conversely, overtreated can increase morbidity. For example, severe chest pain following cardiac or pulmonary surgery impairs the patient's respiratory rehabilitation, which can lead to fluid retention and, consequently, pneumonia. Conversely, overtreatment through excessive use of opioids can cause drowsiness and respiratory depression. Currently, planning postoperative pain management for intubated, ventilated, and sedated patients relies on indirect signs of pain assessed using scales, and on the clinician's subjective judgment. It is only after sedation is discontinued that the actual level of pain can be assessed, once the patient becomes communicative, which then allows analgesic treatment to be adjusted to the pain. This approach inevitably results in a period of discomfort and pain for the patient. In addition to semi-quantitative and subjective scales, a number of analgesia monitoring tools have been developed. Among these, the use of pupillometry and the Pupillary Pain Index (PPI) during surgeries (gynecological, pediatric, cardiac) has been associated with a reduction in intraoperative opioid doses and a decrease in postoperative pain. In our department, pupillometry is routinely used to assess analgesia in intubated, ventilated, and sedated patients undergoing painful procedures. This method is integrated into standard care in the operating room in accordance with the PUCCAR study algorithm, as well as in the intensive care unit according to a specific departmental protocol, in addition to standard assessment scores. We hypothesize that performing pupillometry with a PPI score is predictive of pain intensity at extubation. If our hypothesis is confirmed, this would allow us to tailor analgesic management for each patient prior to discontinuing sedation.

Interventions

OTHERPupilometry

Conducting pupillometry with a PPI score upon discontinuation of sedation in the intensive care unit

OTHERVAS

Measurement of pain intensity using the visual analog scale (VAS ou EVA)

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* A person who has given verbal consent * An adult patient * A patient scheduled for heart surgery

Exclusion criteria

* A person who is not enrolled in or eligible for a social security program * A person subject to a legal protective measure (guardianship, conservatorship) * Person subject to a judicial safeguard measure * Pregnant, laboring, or breastfeeding woman * Adult who is legally incapacitated or unable to give consent * Minor * Patient with preoperative cognitive impairment (MMS)

Design outcomes

Primary

MeasureTime frameDescription
Pain assessment using a visual analog scaleImmediately after surgeryFirst VAS (Visual Analog Scale, 0-10) measurement taken 5 to 15 minutes after extubation, as soon as the patient is able to communicate reliably. Dichotomous variable: VAS \>3 (severe pain) versus VAS ≤3 (tolerable pain).

Countries

France

Contacts

CONTACTVivien BERTHOUD
vivien.berthoud@gmail.com06.72.76.00.74

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026