Evaluating the Efficacy and Utility of the Automated Pupillometer in Pain Assessment and Opioid Administration Guidance During the Perioperative Period: A Randomized Controlled Trial
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Kuala Lumpur
-
Kuala Lumpur, Kuala Lumpur, Malesia, 59100
- Universiti Malaya Medical Centre
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: 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 |
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.
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. |
|
Muut: 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.
|
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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
post operative opioid consumption
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
The correlation between pupillary response metrics (% change, constriction velocity, dilatation velocity, NPi) and opioid dosage administered.
Aikaikkuna: 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.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Kipu
- Neurologiset ilmenemismuodot
- Postoperatiiviset komplikaatiot
- Patologiset prosessit
- Patologiset tilat, merkit ja oireet
- Merkit ja oireet
- Kipu, Leikkauksen jälkeinen
- Huumeiden fysiologiset vaikutukset
- Ääreishermoston aineet
- Keskushermostoa lamaavat aineet
- Aistijärjestelmän edustajat
- Analgeetit
- Huumausaineet
- Farmakologiset vaikutukset
- Kemialliset vaikutukset ja käyttötarkoitukset
- Terapeuttinen käyttö
- Keskushermoston edustajat
- Analgeetit, opioidit
Muut tutkimustunnusnumerot
- 202541314965
- BKP004-2025-ECRG (Muu apuraha/rahoitusnumero: EARLY CAREER RESEARCH GRANT (BKP-ECRG) 2025 UNIVERSITI MALAYA)
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