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Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures

10 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

80

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.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Sevim Bahar Bedirhan, MD
  • Numéro de téléphone: +90 212 414 71 71
  • E-mail: sbbedirhan@gmail.com

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:

  • 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

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: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: Dexmedetomidine
Dexmedetomidine 200 mcg diluted in 100 mL isotonic saline and administered according to the study protocol.
Comparateur actif: 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.
Médicament: Dexmedetomidine
Dexmedetomidine 200 mcg diluted in 100 mL isotonic saline and administered according to the study protocol.
Médicament: Remifentanil
Remifentanil 5 mg diluted in 100 mL isotonic saline and administered according to the study protocol.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of Opioid-Related Adverse Symptoms
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Quality of Recovery (QoR-15) Score
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Pain and Analgesic Outcomes
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

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

Parrainer

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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 (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 février 2028

Achèvement de l'étude (Estimé)

1 février 2028

Dates d'inscription aux études

Première soumission

4 juin 2026

Première soumission répondant aux critères de contrôle qualité

10 juin 2026

Première publication (Réel)

16 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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