Colonoscopy, Endoscopic Retrograde Cholangiopancreatography (ERCP), Endoscopy, Sedation
Conditions
Keywords
Dexmedetomidine, Opioid-Free Sedation, Remifentanil, Sedation, Endoscopy
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.
Interventions
DRUGDexmedetomidine
Dexmedetomidine 200 mcg diluted in 100 mL isotonic saline and administered according to the study protocol.
DRUGRemifentanil
Remifentanil 5 mg diluted in 100 mL isotonic saline and administered according to the study protocol.
Sponsors
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomly assigned to one of two parallel groups. Group I will receive dexmedetomidine alone (opioid-free sedation), and Group II will receive dexmedetomidine combined with remifentanil (opioid-based sedation) during gastroscopy, colonoscopy, or ERCP procedures. Outcomes will be compared between the two groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Opioid-Related Adverse Symptoms | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery (QoR-15) Score | 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. |
| Patient Satisfaction Score | 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. |
| Surgeon Satisfaction Score | 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. |
| Recovery Nurse Satisfaction Score | 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. |
Contacts
CONTACTTuğba Yücel Yenice, MD
CONTACTSevim Bahar Bedirhan, MD
Outcome results
None listed