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Validation of the PRST Score Against Bispectral Index

11 mai 2026 mis à jour par: Dady Sudadi, Gadjah Mada University

Validation of the PRST Score Against Bispectral Index During General Anesthesia: A Randomized Controlled Trial

The goal of this randomized controlled trial is to evaluate whether the PRST (Evans) score is a valid method for monitoring the depth of general anesthesia in adult surgical patients. It will also assess whether combining the PRST score with Bispectral Index (BIS) monitoring improves anesthetic depth assessment compared with PRST-guided monitoring alone.

The main questions it aims to answer are:

  1. Does the PRST score correlate with BIS values during general anesthesia?
  2. Does visible BIS-guided monitoring improve anesthetic depth assessment compared with PRST-guided monitoring alone?

Researchers will compare patients managed using PRST-guided monitoring alone with patients managed using PRST plus visible BIS-guided monitoring.

Participants will:

  1. Undergo elective surgery under general anesthesia
  2. Receive intraoperative anesthetic depth monitoring using PRST score alone or PRST combined with BIS monitoring
  3. Have PRST score, BIS, heart rate, and blood pressure recorded at predefined intraoperative timepoints
  4. Complete a postoperative interview assessing recall, dreaming, and anesthesia-related discomfort

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This single-center, parallel-group randomized controlled trial (RCT) aims to evaluate the validity of the PRST (Evans) score for monitoring the depth of general anesthesia and to assess its relationship with Bispectral Index (BIS) monitoring in adult surgical patients undergoing elective procedures under general anesthesia.

Intraoperative awareness remains a clinically important complication during general anesthesia. Traditional clinical assessment methods such as the PRST score evaluate autonomic responses including systolic blood pressure, heart rate, sweating, and lacrimation, whereas BIS provides an electroencephalography-based objective assessment of hypnotic depth. This study investigates whether combining PRST assessment with BIS monitoring may improve anesthetic depth evaluation compared with PRST-guided monitoring alone.

Eligible participants are randomized into either a PRST-guided monitoring group or a PRST plus visible BIS-guided monitoring group. Standard anesthetic induction and maintenance protocols are applied in both groups. In the intervention group, BIS monitoring is used as an adjunctive tool to guide anesthetic depth management, with a target BIS range of 40-60.

PRST score, BIS values, heart rate (HR), and mean arterial pressure (MAP) are recorded at predefined intraoperative timepoints including T0 (baseline before induction), T1 (after induction before laryngoscopy), T2 (1-3 minutes after airway instrumentation), T3 (before skin incision), T4 (5 minutes after incision), and T5-T6 (15 and 30 minutes during the maintenance phase). Postoperative interviews are conducted to evaluate recall, dreaming, and anesthesia-related discomfort.

The primary objective is to determine the association between PRST score and BIS values during general anesthesia. Secondary objectives include evaluation of hemodynamic responses, anesthetic delivery variables, postoperative recall-related events, and the diagnostic performance of PRST score in identifying BIS-defined light anesthesia.

Type d'étude

Interventionnel

Inscription (Réel)

183

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Indonésie
    • Special Region of Yogyakarta
      • Yogyakarta, Special Region of Yogyakarta, Indonésie, 55281
        • RSUP Dr. Sardjito

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Scheduled for elective surgery under general anesthesia

Exclusion Criteria:

  • Unstable hemodynamic conditions
  • Contraindications to specific anesthetic agents or significant neurological disorders (e.g., Parkinson's disease, stroke, or dementia)
  • Receiving medications known to influence EEG activity, such as anticonvulsants
  • Unable to provide informed consent

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Control (PRST group)
Participants in this group will undergo elective surgery under general anesthesia with anesthetic depth managed using standard clinical monitoring and PRST-guided assessment. PRST components, including systolic blood pressure response, heart rate response, sweating, and lacrimation, will be assessed at predefined intraoperative timepoints.
Dispositif: PRST Monitoring
Clinical anesthetic depth monitoring using PRST score assessment without visible BIS-guided titration.
Expérimental: Intervention (PRST + BIS group)
Participants in this group will undergo elective surgery under general anesthesia with anesthetic depth managed using standard clinical monitoring, PRST-guided assessment, and visible BIS monitoring. BIS monitoring will be initiated after induction and used as an adjunct to guide hypnotic depth titration, with a typical target BIS range of 40-60. PRST score, BIS values, and hemodynamic parameters will be recorded at predefined intraoperative timepoints.
Dispositif: PRST + BIS Monitoring
Clinical anesthetic depth monitoring using PRST score combined with visible BIS-guided anesthetic titration targeting BIS 40-60.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
PRST score
Délai: T0 (baseline before induction), T1 (after induction before laryngoscopy), T2 (1-3 minutes after airway instrumentation), T3 (before skin incision), T4 (5 minutes after incision), and T5-T6 (15 and 30 minutes during the maintenance phase).
PRST components were assessed as follows: SBP response (increase from baseline <15 mmHg = 0; 15-30 mmHg = 1; >30 mmHg = 2), HR response (increase from baseline <15 bpm = 0; 15-30 bpm = 1; >30 bpm = 2), sweating (absent = 0; present = 1), and lacrimation (absent = 0; present = 1). The total PRST score ranged from 0 to 6 with higher scores indicating greater autonomic response to nociceptive stimuli.
T0 (baseline before induction), T1 (after induction before laryngoscopy), T2 (1-3 minutes after airway instrumentation), T3 (before skin incision), T4 (5 minutes after incision), and T5-T6 (15 and 30 minutes during the maintenance phase).
BIS Score
Délai: T0 (baseline before induction), T1 (after induction before laryngoscopy), T2 (1-3 minutes after airway instrumentation), T3 (before skin incision), T4 (5 minutes after incision), and T5-T6 (15 and 30 minutes during the maintenance phase).
Bispectral Index (BIS) monitoring is an electroencephalography-based anesthetic depth monitoring system used to assess the hypnotic state during general anesthesia. In this study, BIS monitoring is initiated after anesthetic induction and used as an adjunctive tool to guide anesthetic depth management, with a target BIS range of 40-60 during maintenance of general anesthesia. Continuous BIS values are recorded throughout the intraoperative period to evaluate anesthetic depth and correlation with PRST score measurements.
T0 (baseline before induction), T1 (after induction before laryngoscopy), T2 (1-3 minutes after airway instrumentation), T3 (before skin incision), T4 (5 minutes after incision), and T5-T6 (15 and 30 minutes during the maintenance phase).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Heart Rate
Délai: T0 (baseline before induction), T1 (after induction before laryngoscopy), T2 (1-3 minutes after airway instrumentation), T3 (before skin incision), T4 (5 minutes after incision), and T5-T6 (15 and 30 minutes during the maintenance phase).
T0 (baseline before induction), T1 (after induction before laryngoscopy), T2 (1-3 minutes after airway instrumentation), T3 (before skin incision), T4 (5 minutes after incision), and T5-T6 (15 and 30 minutes during the maintenance phase).
Mean Arterial Pressure
Délai: T0 (baseline before induction), T1 (after induction before laryngoscopy), T2 (1-3 minutes after airway instrumentation), T3 (before skin incision), T4 (5 minutes after incision), and T5-T6 (15 and 30 minutes during the maintenance phase).
T0 (baseline before induction), T1 (after induction before laryngoscopy), T2 (1-3 minutes after airway instrumentation), T3 (before skin incision), T4 (5 minutes after incision), and T5-T6 (15 and 30 minutes during the maintenance phase).
Sevoflurane dial setting
Délai: T3 (before skin incision), T4 (5 minutes after incision), and T5-T6 (15 and 30 minutes during the maintenance phase).
Sevoflurane dial setting refers to the vaporizer concentration setting used to deliver inhaled sevoflurane during maintenance of general anesthesia. In this study, sevoflurane concentration is adjusted intraoperatively according to anesthetic depth assessment and clinical monitoring parameters, including PRST score and BIS monitoring when applicable.
T3 (before skin incision), T4 (5 minutes after incision), and T5-T6 (15 and 30 minutes during the maintenance phase).
End-tidal minimum alveolar concentration (MAC) values
Délai: T3 (before skin incision), T4 (5 minutes after incision), and T5-T6 (15 and 30 minutes during the maintenance phase).
End-tidal minimum alveolar concentration (MAC) values represent the measured concentration of inhaled anesthetic agent in exhaled gas and are used as an indicator of anesthetic potency during general anesthesia. In this study, end-tidal MAC values are continuously monitored intraoperatively and recorded at predefined timepoints to evaluate anesthetic delivery and depth of anesthesia in relation to PRST score and BIS monitoring.
T3 (before skin incision), T4 (5 minutes after incision), and T5-T6 (15 and 30 minutes during the maintenance phase).
Postoperative discomfort
Délai: Immediately after recovery from general anesthesia
Postoperative discomfort refers to patient-reported unpleasant physical or psychological experiences following general anesthesia and surgery. Assessment is performed postoperatively using structured interview questions evaluating discomfort related to anesthesia, intraoperative experience, or recovery period. Responses are recorded and compared between study groups.
Immediately after recovery from general anesthesia
Dreaming
Délai: Immediately after recovery from general anesthesia
Dreaming refers to patient-reported dream experiences occurring during the peri-anesthetic period under general anesthesia. Assessment is performed postoperatively using structured interview questions adapted from the modified Brice interview to identify the presence or absence of dreaming during anesthesia and recovery. Responses are recorded and compared between study groups.
Immediately after recovery from general anesthesia

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Gadjah Mada University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

26 octobre 2025

Achèvement primaire (Réel)

5 janvier 2026

Achèvement de l'étude (Réel)

5 janvier 2026

Dates d'inscription aux études

Première soumission

11 mai 2026

Première soumission répondant aux critères de contrôle qualité

11 mai 2026

Première publication (Réel)

15 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • PRST-BIS-RCT-2026

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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