Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Tuğba Yücel Yenice, MD
- Número de teléfono: +90 212 414 71 71
- Correo electrónico: tugbayucel09@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Sevim Bahar Bedirhan, MD
- Número de teléfono: +90 212 414 71 71
- Correo electrónico: sbbedirhan@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
|
Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of Opioid-Related Adverse Symptoms
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality of Recovery (QoR-15) Score
Periodo de tiempo: 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.
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Baseline (before the procedure) and within 2 hours after the procedure, before discharge from the recovery area
|
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Patient Satisfaction Score
Periodo de tiempo: 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.
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Within 1 hour after the procedure, before discharge from the recovery area
|
|
Surgeon Satisfaction Score
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain and Analgesic Outcomes
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Mean Arterial Pressure (MAP)
Periodo de tiempo: 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.
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Perioperative/Periprocedural, at 6 predefined time points over approximately 1-3 hours
|
|
Oxygen Saturation (SpO2)
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Yu JM, Tao QY, He Y, Liu D, Niu JY, Zhang Y. Opioid-Free Anesthesia for Pain Relief After Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial. J Pain Res. 2023 Oct 30;16:3625-3632. doi: 10.2147/JPR.S432601. eCollection 2023.
- Hao C, Xu H, Du J, Zhang T, Zhang X, Zhao Z, Luan H. Impact of Opioid-Free Anesthesia on Postoperative Quality of Recovery in Patients After Laparoscopic Cholecystectomy-A Randomized Controlled Trial. Drug Des Devel Ther. 2023 Nov 28;17:3539-3547. doi: 10.2147/DDDT.S439674. eCollection 2023.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2024-KAEK-31 (Sisli Hamidiye Etfal Training and Research Hospital Clinical Research Ethics Committee)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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