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Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures

10. Juni 2026 aktualisiert von: Nalan Saygi Emir, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Evaluation of an Opioid-Free Approach in Sedation Method Selection in Endoscopy Units: A Prospective Randomized Observational Double-Blind Comparison of Dexmedetomidine (Opioid-Free) and Remifentanil-Dexmedetomidine (Opioid-Based) Combination

This study will compare two different sedation approaches used during gastroscopy, colonoscopy, and endoscopic retrograde cholangiopancreatography (ERCP). One group will receive dexmedetomidine alone (opioid-free sedation), while the other group will receive dexmedetomidine combined with remifentanil (opioid-based sedation).

The purpose of the study is to determine whether an opioid-free sedation approach can reduce opioid-related adverse symptoms, such as nausea, vomiting, dizziness, drowsiness, dry mouth, headache, and fatigue. The study will also evaluate quality of recovery, patient and healthcare staff satisfaction, hemodynamic effects, complications, and time to discharge after the procedure.

Studienübersicht

Detaillierte Beschreibung

Safe and comfortable sedation is essential for endoscopic procedures performed outside the operating room. Various sedation strategies have been developed to improve patient safety, procedural conditions, and recovery profiles. Opioids are commonly used as part of sedation regimens; however, opioid administration may be associated with adverse symptoms such as nausea, vomiting, dizziness, drowsiness, difficulty concentrating, fatigue, pruritus, dry mouth, and headache.

This prospective randomized double-blind study will compare dexmedetomidine alone (opioid-free approach) with a combination of dexmedetomidine and remifentanil (opioid-based approach) for sedation during gastroscopy, colonoscopy, and endoscopic retrograde cholangiopancreatography (ERCP). Eighty ASA physical status I-III patients aged 18-80 years will be enrolled at a single center.

Participants will be randomly assigned to one of two study groups using a computer-generated randomization sequence. Study medications will be prepared by an independent anesthesiologist to maintain blinding. In both groups, dexmedetomidine infusion will be administered. The comparison group will additionally receive remifentanil infusion according to the study protocol.

The primary objective is to determine whether the opioid-free approach reduces the incidence of opioid-related adverse symptoms. Secondary objectives include evaluation of postoperative quality of recovery using the QoR-15 questionnaire and assessment of patient, surgeon, and recovery nurse satisfaction. Additional outcomes include hemodynamic parameters, sedation scores, pain scores, rescue analgesic requirements, discharge time, post-anesthesia care unit requirements, and procedure- or anesthesia-related complications.

Studientyp

Interventionell

Einschreibung (Geschätzt)

80

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienkontakt

Studieren Sie die Kontaktsicherung

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:

  • Age 18 to 85 years
  • ASA physical status I-III
  • Scheduled for ERCP, gastroscopy, or colonoscopy

Exclusion Criteria:

  • Refusal to participate in the study
  • Inability to communicate
  • Alcohol or substance abuse
  • Neuropsychiatric disease
  • Severe respiratory failure
  • Severe heart failure
  • Pregnancy
  • Body mass index (BMI) >30 kg/m²
  • Hearing impairment
  • History of allergy to study medications
  • Requirement for orotracheal intubation or general anesthesia
  • Procedures lasting less than 20 minutes

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Dexmedetomidine (Opioid-Free)
Participants will receive dexmedetomidine infusion for procedural sedation. Dexmedetomidine infusion will be initiated at 0.7 mcg/kg/h. Five minutes later, a placebo infusion (100 mL isotonic saline) will be started. Sedation will be induced with propofol 1.5 mg/kg IV bolus and maintained according to the study protocol.
Dexmedetomidine 200 mcg diluted in 100 mL isotonic saline and administered according to the study protocol.
Aktiver Komparator: Remifentanil + Dexmedetomidine
Participants will receive dexmedetomidine infusion at 0.7 mcg/kg/h. Five minutes later, remifentanil infusion will be initiated at 0.01-0.03 mcg/kg/min. Sedation will be induced with propofol 1.5 mg/kg IV bolus and maintained according to the study protocol.
Dexmedetomidine 200 mcg diluted in 100 mL isotonic saline and administered according to the study protocol.
Remifentanil 5 mg diluted in 100 mL isotonic saline and administered according to the study protocol.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of Opioid-Related Adverse Symptoms
Zeitfenster: Perioperative/Periprocedural: from procedure start through recovery room discharge, approximately 2-4 hours
Incidence of opioid-related adverse symptoms including nausea, vomiting, difficulty concentrating, difficulty staying awake, dizziness, sleepiness, general fatigue or weakness, pruritus, dry mouth, and headache. The occurrence of one or more symptoms will be recorded and compared between the opioid-free and opioid-based sedation groups.
Perioperative/Periprocedural: from procedure start through recovery room discharge, approximately 2-4 hours

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Quality of Recovery (QoR-15) Score
Zeitfenster: Baseline (before the procedure) and within 2 hours after the procedure, before discharge from the recovery area
Postprocedural quality of recovery assessed using the QoR-15 questionnaire. The QoR-15 is a 15-item instrument evaluating five dimensions: physical comfort (5 items), emotional state (4 items), physical independence (2 items), psychological support (2 items), and pain (2 items). Each item is scored 0-10 on a Likert scale; total score ranges from 0 (worst) to 150 (best quality of recovery). Administered to all patients before the procedure (baseline) and after the procedure before discharge.
Baseline (before the procedure) and within 2 hours after the procedure, before discharge from the recovery area
Patient Satisfaction Score
Zeitfenster: Within 1 hour after the procedure, before discharge from the recovery area
Patient satisfaction assessed using a verbal rating scale from 1 to 10 (1: not satisfied at all, 10: very satisfied). Administered once after the procedure before discharge from the recovery area.
Within 1 hour after the procedure, before discharge from the recovery area
Surgeon Satisfaction Score
Zeitfenster: Immediately after the procedure
Surgeon satisfaction with procedural conditions assessed using a verbal rating scale from 1 to 10 (1: not satisfied at all, 10: very satisfied). Assessed immediately after the procedure.
Immediately after the procedure
Recovery Nurse Satisfaction Score
Zeitfenster: During the recovery period, before discharge
Recovery nurse satisfaction assessed using a verbal rating scale from 1 to 10 (1: not satisfied at all, 10: very satisfied). Assessed during the recovery period before discharge.
During the recovery period, before discharge

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain and Analgesic Outcomes
Zeitfenster: During the recovery period before discharge
Postprocedural pain assessed using the Visual Analog Scale (VAS; 0-10). Target VAS <4. Rescue analgesia administered as IV paracetamol 1g; tramadol 50 mg IV if insufficient. Total rescue analgesic consumption recorded.
During the recovery period before discharge
Post-Anesthesia Care Unit (PACU) Requirement
Zeitfenster: Immediately after the procedure
Need for post-anesthesia care unit (PACU) admission following the procedure. Discharge from the recovery unit will be based on the Modified Aldrete Score. The Modified Aldrete Score ranges from 0 to 10, with higher scores indicating better recovery status. Patients with a score of ≥9 will be considered eligible for discharge from the recovery unit.
Immediately after the procedure
Heart Rate
Zeitfenster: Perioperative/Periprocedural, at 6 predefined time points over approximately 1-3 hours
Heart rate measured in beats per minute (bpm) at 6 standardized time points: (1) on arrival to the procedure room, (2) immediately after induction, (3) 3 minutes after procedure start, (4) 15 minutes after procedure start, (5) at the end of the procedure, (6) on arrival to the recovery room.
Perioperative/Periprocedural, at 6 predefined time points over approximately 1-3 hours
Mean Arterial Pressure (MAP)
Zeitfenster: Perioperative/Periprocedural, at 6 predefined time points over approximately 1-3 hours
Mean arterial pressure measured in millimeters of mercury (mmHg) at 6 standardized time points: (1) on arrival to the procedure room, (2) immediately after induction, (3) 3 minutes after procedure start, (4) 15 minutes after procedure start, (5) at the end of the procedure, (6) on arrival to the recovery room.
Perioperative/Periprocedural, at 6 predefined time points over approximately 1-3 hours
Oxygen Saturation (SpO2)
Zeitfenster: Perioperative/Periprocedural, at 6 predefined time points over approximately 1-3 hours
Peripheral oxygen saturation measured as percentage (%) at 6 standardized time points: (1) on arrival to the procedure room, (2) immediately after induction, (3) 3 minutes after procedure start, (4) 15 minutes after procedure start, (5) at the end of the procedure, (6) on arrival to the recovery room.
Perioperative/Periprocedural, at 6 predefined time points over approximately 1-3 hours
Ramsay Sedation Scale Score
Zeitfenster: Perioperative/Periprocedural, at 6 predefined time points over approximately 1-3 hours

Sedation depth assessed using the Ramsay Sedation Scale at 6 standardized time points: (1) on arrival to the procedure room, (2) immediately after induction, (3) 3 minutes after procedure start, (4) 15 minutes after procedure start, (5) at the end of the procedure, (6) on arrival to the recovery room.

Ramsay Sedation Scale (RSS; ranging from 1 to 6, where 1 = anxious/agitated/restless and 6 = no response to stimulus; higher scores indicate deeper sedation)

Perioperative/Periprocedural, at 6 predefined time points over approximately 1-3 hours

Mitarbeiter und Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

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 (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. Februar 2028

Studienabschluss (Geschätzt)

1. Februar 2028

Studienanmeldedaten

Zuerst eingereicht

4. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Juni 2026

Zuerst gepostet (Tatsächlich)

16. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 2024-KAEK-31 (Sisli Hamidiye Etfal Training and Research Hospital Clinical Research Ethics Committee)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data collected during this study will not be made publicly available.

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 .

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