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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Primary Endpoint
- Incidence of Opioid-Related Adverse Symptoms
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Dexmedetomidine (Drug)
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.
Intervention: Dexmedetomidine (Drug)
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.
Intervention: Remifentanil (Drug)
Outcomes
Primary Outcomes
Incidence of Opioid-Related Adverse Symptoms
Time Frame: 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.
Secondary Outcomes
- Quality of Recovery (QoR-15) Score(Baseline (before the procedure) and within 2 hours after the procedure, before discharge from the recovery area)
- Patient Satisfaction Score(Within 1 hour after the procedure, before discharge from the recovery area)
- Surgeon Satisfaction Score(Immediately after the procedure)
- Recovery Nurse Satisfaction Score(During the recovery period, before discharge)
Investigators
Nalan Saygi Emir
Associate Professor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital