Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures

10 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Dexmedetomidine
Dexmedetomidine 200 mcg diluted in 100 mL isotonic saline and administered according to the study protocol.
Actieve vergelijker: 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.
Geneesmiddel: Dexmedetomidine
Dexmedetomidine 200 mcg diluted in 100 mL isotonic saline and administered according to the study protocol.
Geneesmiddel: Remifentanil
Remifentanil 5 mg diluted in 100 mL isotonic saline and administered according to the study protocol.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Opioid-Related Adverse Symptoms
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Quality of Recovery (QoR-15) Score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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 uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain and Analgesic Outcomes
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 februari 2028

Studie voltooiing (Geschat)

1 februari 2028

Studieregistratiedata

Eerst ingediend

4 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 juni 2026

Eerst geplaatst (Werkelijk)

16 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

10 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren