Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine, Remifentanil.
- Who it may be relevant to
- Registry conditions: Sedation, Endoscopy, Colonoscopy, Endoscopic Retrograde Cholangiopancreatography (ERCP). Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
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.
Interventions
- Drug Dexmedetomidine
Dexmedetomidine 200 mcg diluted in 100 mL isotonic saline and administered according to the study protocol. - Drug Remifentanil
Remifentanil 5 mg diluted in 100 mL isotonic saline and administered according to the study protocol.
Primary outcome measures
- Incidence of Opioid-Related Adverse Symptoms [Time frame: Perioperative/Periprocedural: from procedure start through recovery room discharge, approximately 2-4 hours]
Secondary outcome measures (4)
- Quality of Recovery (QoR-15) Score [Time frame: Baseline (before the procedure) and within 2 hours after the procedure, before discharge from the recovery area]
- Patient Satisfaction Score [Time frame: Within 1 hour after the procedure, before discharge from the recovery area]
- Surgeon Satisfaction Score [Time frame: Immediately after the procedure]
- Recovery Nurse Satisfaction Score [Time frame: During the recovery period, before discharge]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
Identifiers
NCT: NCT07649746 · 2024-KAEK-31