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Validation of the PRST Score Against Bispectral Index

11. května 2026 aktualizováno: 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

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

183

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Diagnostický
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.
Přístroj: PRST Monitoring
Clinical anesthetic depth monitoring using PRST score assessment without visible BIS-guided titration.
Experimentální: 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.
Přístroj: PRST + BIS Monitoring
Clinical anesthetic depth monitoring using PRST score combined with visible BIS-guided anesthetic titration targeting BIS 40-60.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
PRST score
Časové okno: 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
Časové okno: 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).

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Heart Rate
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Gadjah Mada University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

26. října 2025

Primární dokončení (Aktuální)

5. ledna 2026

Dokončení studie (Aktuální)

5. ledna 2026

Termíny zápisu do studia

První předloženo

11. května 2026

První předloženo, které splnilo kritéria kontroly kvality

11. května 2026

První zveřejněno (Aktuální)

15. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

15. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • PRST-BIS-RCT-2026

Plán pro data jednotlivých účastníků (IPD)

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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