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

NCT07648342 | Not Yet Recruiting

• 1 other identifier: BERTHOUD 2026
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Scheduled for Surgery

Outcome Measures

Primary Outcomes (1)

• Pain assessment using a visual analog scale

  First 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).

  Immediately after surgery

Study Arms (1)

Patients scheduled for heart surgery

Other: Pupilometry; Other: VAS

Interventions

Pupilometry OTHER

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

Patients scheduled for heart surgery

VAS OTHER

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

Patients scheduled for heart surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient scheduled for heart surgery

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

Central Study Contacts

Vivien BERTHOUD

CONTACT

06.72.76.00.74; vivien.berthoud@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

FR (1)