SedationNCT07649746
Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures
A study testing Dexmedetomidine and Remifentanil in people with Sedation and Endoscopy, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sedation, Endoscopy, Colonoscopy
- What is being tested?
- Dexmedetomidine and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 85 years
- ASA physical status I-III
- Scheduled for ERCP, gastroscopy, or colonoscopy
Who cannot join
- Refusal to participate in the study
- Inability to communicate
- Alcohol or substance abuse
- Neuropsychiatric disease
- Severe respiratory failure
- Severe heart failure
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Being tested
- Dexmedetomidine, Remifentanil
- Keywords
- Dexmedetomidine, Opioid-Free Sedation, Remifentanil, Sedation, Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine 200 mcg diluted in 100 mL isotonic saline and administered according to the study protocol.
RemifentanilDrug
Remifentanil 5 mg diluted in 100 mL isotonic saline and administered according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine (Opioid-Free) | Experimental | 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. Receives: Drug: Dexmedetomidine |
| Remifentanil + Dexmedetomidine | Active comparator | 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. Receives: Drug: Dexmedetomidine; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Opioid-Related Adverse Symptoms
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.
Measured: Perioperative/Periprocedural: from procedure start through recovery room discharge, approximately 2-4 hours
Secondary outcomes (4)
Quality of Recovery (QoR-15) Score
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.
Measured: Baseline (before the procedure) and within 2 hours after the procedure, before discharge from the recovery area
Patient Satisfaction Score
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.
Measured: Within 1 hour after the procedure, before discharge from the recovery area
Surgeon Satisfaction Score
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.
Measured: Immediately after the procedure
Recovery Nurse Satisfaction Score
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.
Measured: During the recovery period, before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nalan Saygi Emir, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649746
- Sponsor's protocol ID
- 2024-KAEK-31
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during this study will not be made publicly available.
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.
PubMed 37928062Hao 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.
PubMed 38046284
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07649746
- Acronym / sponsor ID
- 2024-KAEK-31
- Keywords
- Dexmedetomidine, Opioid-Free Sedation, Remifentanil, Sedation, Endoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- Jun 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine (Opioid-Free) | Experimental | Drug: DexmedetomidineParticipants 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. |
| Remifentanil + Dexmedetomidine | Active comparator | Drug: Dexmedetomidine, Drug: RemifentanilParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 85 years
- ASA physical status I-III
- Scheduled for ERCP, gastroscopy, or colonoscopy
Key exclusion criteria (12 listed)
- Refusal to participate in the study
- Inability to communicate
- Alcohol or substance abuse
- Neuropsychiatric disease
- Severe respiratory failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineDexmedetomidine 200 mcg diluted in 100 mL isotonic saline and administered according to the study protocol. | Drug | Dexmedetomidine (Opioid-Free), Remifentanil + Dexmedetomidine |
| RemifentanilRemifentanil 5 mg diluted in 100 mL isotonic saline and administered according to the study protocol. | Drug | Remifentanil + Dexmedetomidine |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 37928062Yu 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.
- Background: PubMed 38046284Hao 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.
- Individual participant dataSharing planned: No. Individual participant data collected during this study will not be made publicly available.
Related trials for Sedation
Active, not recruiting
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Critical Illness
Recruiting
The Effect of Remimazolam Tosylate on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial
Delirium - Postoperative
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
Recruiting
Recovery Time With the Application of ALDRETE Score in Patients Undergoing Gastrointestinal Endoscopy
Patients Undergoing Gastrointestinal Endoscopy
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Remifentanil in people with Sedation and Endoscopy, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuğba Yücel Yenice, MD (+90 212 414 71 71, tugbayucel09@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Opioid-Related Adverse Symptoms (time frame: Perioperative/Periprocedural: from procedure start through recovery room discharge, approximately 2-4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07649746, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.