Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Validation of the PRST Score Against Bispectral Index

11. Mai 2026 aktualisiert von: 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

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

183

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Gerät: PRST Monitoring
Clinical anesthetic depth monitoring using PRST score assessment without visible BIS-guided titration.
Experimental: 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.
Gerät: PRST + BIS Monitoring
Clinical anesthetic depth monitoring using PRST score combined with visible BIS-guided anesthetic titration targeting BIS 40-60.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PRST score
Zeitfenster: 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
Zeitfenster: 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).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Heart Rate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Gadjah Mada University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

26. Oktober 2025

Primärer Abschluss (Tatsächlich)

5. Januar 2026

Studienabschluss (Tatsächlich)

5. Januar 2026

Studienanmeldedaten

Zuerst eingereicht

11. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Mai 2026

Zuerst gepostet (Tatsächlich)

15. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • PRST-BIS-RCT-2026

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Vollnarkose

Klinische Studien zur PRST Monitoring

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Estonia

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren