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Evaluating the Efficacy and Utility of the Automated Pupillometer in Pain Assessment and Opioid Administration Guidance During the Perioperative Period: A Randomized Controlled Trial

20 mei 2026 bijgewerkt door: YEAP CHUN HONG, University of Malaya

Effective intraoperative and postoperative pain management is critical for patient comfort and recovery, yet traditional methods for assessing pain under general anaesthesia are limited by their subjective nature and reliance on vital signs. Automated pupillometry, which gives the parameters of the pupillary light reflex (PLR) components, offers an objective and quantitative approach to evaluating nociception and pain.

This study aims to evaluate the effectiveness of the automated pupillometry in enhancing early postoperative pain control and to assess its utility in guiding opioid administration during the perioperative period.

A prospective, non-blinded randomized controlled trial will be conducted with 68 patients undergoing laparotomy for gastrointestinal surgery. Participants will be randomly assigned to either an interventional group, where analgesia is guided by automated pupillometry measurements, or a control group receiving standard pain management. Key outcomes include the time to first rescue analgesia, self-reported pain scores, opioid consumption. The automated pupillometry measurements will be taken at key surgical moments, including before induction, pre-incision, and during recovery.

Pain scores and rescue analgesia use will be compared between groups using appropriate statistical tests, and Kaplan-Meier survival curves will analyze time to first rescue analgesia. Regression analyses will explore the relationship between pupillometry readings and postoperative pain.

It is anticipated that the automated pupillometry guided group will experience longer intervals before requiring rescue analgesia and report lower pain scores, suggesting improved pain management and reduced opioid use.

This study could validate automated pupillometry as an innovative tool for optimizing postoperative pain management, potentially improving patient outcomes by enabling more precise and effective analgesia in surgical settings.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

68

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Maleisië
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Maleisië, 59100
        • Universiti Malaya Medical Centre

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • 1. Patients aged 18 - 70 years old scheduled for elective/emergency laparotomy with clear awareness and good communication
  • 2. ASA (American Society of Anaesthesiologists) physical status I-III
  • 3. Expected to have moderate to severe pain in the early postoperative period

Exclusion Criteria:

  • 1. Patient with known pupillary abnormality (such as anisocoria, pharmacologic dilation, previous intraocular surgery)
  • 2. Pre-existing neurological disorder affecting pupillary reflexes
  • 3. Patients on chronic opioid therapy or with a history of substance abuse
  • 4. Non-consenting patients or those with cognitive impairments affecting informed consent

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Intervention

Participants in the interventional group will receive an initial dose of 100 mcg IV fentanyl during induction. Remifentanil will be administered via effect-site target-controlled infusion (TCI), with a concentration effect (Ce) ranging from 2 to 8 ng/ml, titrated according to the anaesthetist's discretion. TCI remifentanil is increased by 0.5 ng/ml if pupillary diameter changes > 20% of the baseline. Automated pupillometry will be measured before induction , after induction(baseline), before the surgical incision, after surgical incision and during skin closure. Additional analgesics could be administered as control arm.

At the post anaesthesia recovery area, PLR will be measured at 10 min and at 30 min.Anaesthetists will give rescue morphine when the pupillary diameter changes > 20% and repeat the measurement after 5 minutes
Geneesmiddel: Opioid Analgesic
Participants in the interventional group will receive an initial dose of 100 mcg IV fentanyl during induction. Remifentanil will be administered via effect-site target-controlled infusion (TCI), with a concentration effect (Ce) ranging from 2 to 8 ng/ml. TCI remifentanil is increased by 0.5 ng/ml if pupillary diameter changes > 20% of the baseline after induction. The automated pupillometry measurement is repeated 5 mins after increment. Prior to skin closing, IV morphine 0.1 mg/kg during skin closing and automated pupillometry measurement is repeated to aim pupillary diameter is within 20% of baseline. Analgesics is titrated according to the anaesthetist's discretion and reason is documented if it is deviated from the protocol.
Apparaat: automated pupillometry

For both arms, automated pupillometry will be measured before induction , after induction(baseline), before the surgical incision, after surgical incision, during skin closure, at PACU 10 mins and at PACU 30 mins.

For intervention arm only, the additional automated pupillometry measurement will be performed after administration of analgesia.
Ander: Control
Participants in the control group will receive anaesthetic and analgesic management as per the standard practice followed by the attending anaesthetist. Additional analgesics, including intravenous paracetamol, intravenous parecoxib, and abdominal plane blocks, will be provided if there are no contraindications. Automated pupillometry will be measured before induction , after induction(baseline), before the surgical incision, after surgical incision and during skin closure. At the post anaesthesia recovery area, PLR will be measured at 10 min and at 30 min.
Apparaat: automated pupillometry

For both arms, automated pupillometry will be measured before induction , after induction(baseline), before the surgical incision, after surgical incision, during skin closure, at PACU 10 mins and at PACU 30 mins.

For intervention arm only, the additional automated pupillometry measurement will be performed after administration of analgesia.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
post operative opioid consumption
Tijdsspanne: first 24 hours post operatively
the amount of post operative opioid consumption including rescue analgesia and patient controlled analgesia morphine usage would be recorded
first 24 hours post operatively

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The correlation between pupillary response metrics (% change, constriction velocity, dilatation velocity, NPi) and opioid dosage administered.
Tijdsspanne: automated pupillometry measurements will be done before induction, after induction, before skin incision, during skin incision, after skin incision, during skin closure, and at post anaesthesia recovery unit 10 min and 30 min.
To find the measurement changes or correlation with opioiod administration, and to analyse it statistically
automated pupillometry measurements will be done before induction, after induction, before skin incision, during skin incision, after skin incision, during skin closure, and at post anaesthesia recovery unit 10 min and 30 min.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Malaya

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 mei 2026

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 februari 2027

Studieregistratiedata

Eerst ingediend

20 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

20 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

20 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 202541314965
  • BKP004-2025-ECRG (Ander subsidie-/financieringsnummer: EARLY CAREER RESEARCH GRANT (BKP-ECRG) 2025 UNIVERSITI MALAYA)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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