Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Dexmedetomidine
  Dexmedetomidine 200 mcg diluted in 100 mL isotonic saline and administered according to the study protocol.
• Препарат Remifentanil
  Remifentanil 5 mg diluted in 100 mL isotonic saline and administered according to the study protocol.

Первичные конечные точки

• Incidence of Opioid-Related Adverse Symptoms [Срок оценки: Perioperative/Periprocedural: from procedure start through recovery room discharge, approximately 2-4 hours]

Вторичные конечные точки (4)

• Quality of Recovery (QoR-15) Score [Срок оценки: Baseline (before the procedure) and within 2 hours after the procedure, before discharge from the recovery area]
• Patient Satisfaction Score [Срок оценки: Within 1 hour after the procedure, before discharge from the recovery area]
• Surgeon Satisfaction Score [Срок оценки: Immediately after the procedure]
• Recovery Nurse Satisfaction Score [Срок оценки: During the recovery period, before discharge]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 37928062
• 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. PMID 38046284

Идентификаторы

NCT: NCT07649746 · 2024-KAEK-31

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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