Respiratory DepressionNCT07166614
Dexmedetomidine vs Propofol in High-Risk ERCP Patients
A study testing dexmedetomidin and Propofol in people with Respiratory Depression and Hypoxemia, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
ERCP requires deep sedation due to pain and discomfort, but propofol-commonly used with opioids-often causes respiratory and cardiovascular complications, especially in elderly or high-risk patients. Dexmedetomidine offers sedation without respiratory depression but may lower blood pressure and heart rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Depression, Hypoxemia, Hypotension Drug-Induced
- What is being tested?
- dexmedetomidin and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Sep 2025to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 years of age
- ASA physical status III-IV
- scheduled for ERCP in the Gastroenterology Endoscopy Unit of our hospital
Who cannot join
- pregnant women;
- patients with neuropsychiatric disease,
- substance abuse, or known allergy to the sedatives used;
- patients with baseline heart rate ≤50 bpm;
- those who did not provide consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli etfal research and training hospital
Sarıyer, Istanbul, 34371
About this study
Official title: Comparison of Respiratory and Hemodynamic Effects of Dexmedetomidine vs. Propofol in High-Risk Patients Undergoing ERCP: A Prospective Randomized Controlled Study
ERCP requires deep sedation due to pain and discomfort, but propofol-commonly used with opioids-often causes respiratory and cardiovascular complications, especially in elderly or high-risk patients. Dexmedetomidine offers sedation without respiratory depression but may lower blood pressure and heart rate. Current monitoring often relies only on SpO₂, while capnography and the Integrated Pulmonary Index (IPI) provide earlier detection of respiratory events but are underused in ERCP studies.
This study compares dexmedetomidine and propofol in high-risk ERCP patients, focusing on respiratory and hemodynamic effects, propofol consumption, recovery, and discharge times. The hypothesis is that dexmedetomidine will cause fewer adverse respiratory and hemodynamic effects.
Read the detailed description
Endoscopic Retrograde Cholangiopancreatography (ERCP) is uncomfortable and painful for patients. Moreover, immobility is required for procedural success, which necessitates deep sedation. Recently, propofol combined with an opioid has been frequently used for this purpose . However, propofol is associated with respiratory depression, hypoxemia, and hypotension, leading to increased cardiopulmonary complications. These risks become more significant in elderly patients and those with high comorbidity. The use of alternative sedative agents or combinations aims to reduce propofol dosage and minimize cardiopulmonary complications.
Dexmedetomidine is a highly selective α2-adrenoceptor agonist that reduces noradrenergic neuronal activity and is widely used for its sedative and anxiolytic properties. Unlike propofol, dexmedetomidine provides sedation without causing respiratory depression, even at loading doses. Several studies have evaluated the effects of dexmedetomidine and propofol on sedation in gastrointestinal endoscopic procedures . However, dexmedetomidine infusion alone has been shown to be less effective than propofol in terms of sedation quality, and it is associated with significant decreases in blood pressure and heart rate. These adverse events raise concerns regarding the use of dexmedetomidine in high-comorbidity patients requiring stable hemodynamics . Therefore, further studies are needed to evaluate the efficacy and safety of dexmedetomidine versus propofol in high-risk patients undergoing ERCP.
During endoscopy, monitoring of heart rate (HR), arterial blood pressure (BP), and pulse oximetry (SpO₂) is commonly used. Capnography with end-tidal CO₂ (ETCO₂) monitoring enables early detection of hypoventilation and apnea. Accordingly, both national and international guidelines (US and Europe) recommend capnography for monitoring during endoscopic procedures . The Integrated Pulmonary Index (IPI) incorporates HR, respiratory rate, SpO₂, and ETCO₂ parameters into an algorithm (14). It is considered the earliest method for detecting respiratory events and has been shown to be effective during endoscopic sedation.
However, studies evaluating the respiratory effects of sedative agents used in ERCP have been limited to SpO₂ values and adverse events, without assessment of ETCO₂ or IPI parameters.
In the study, the investigator primarily aimed to compare the respiratory and hemodynamic effects of dexmedetomidine versus propofol in high-risk patients undergoing ERCP. Secondarily, we evaluated total propofol consumption, recovery time, and discharge time from the endoscopy unit. Our hypothesis was that dexmedetomidine sedation in high-risk ERCP patients would result in fewer respiratory and hemodynamic side effects compared to propofol.
- Being tested
- dexmedetomidin, Propofol
- Keywords
- Dexmedetomidine, propofol, adverse event, ERCP
- Medical subject headings
- Respiratory Insufficiency, Hypoxia, Hypotension, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidinDrug
Dexmedetomidine is a highly selective α2-adrenergic receptor agonist with sedative, anxiolytic, and analgesic properties. Unlike many other sedatives, it provides sedation without significant respiratory depression, though it may cause bradycardia and hypotension
PropofolDrug
Propofol is a short-acting intravenous anesthetic agent widely used for induction and maintenance of anesthesia as well as procedural sedation. It provides rapid onset and recovery, but is associated with respiratory depression and hypotension
| Study group | Role | What they receive |
|---|---|---|
| group d | Experimental | A loading dose of dexmedetomidine at 1 μg/kg was administered over 10 minutes prior to the procedure. During the procedure, an infusion at 0.5 μg/kg/h was maintained, which was discontinued at the end of the procedure Receives: Drug: dexmedetomidin |
| group p | Active comparator | In our ERCP unit, induction was performed according to the standard protocol using fentanyl 1 µg/kg and propofol 1 mg/kg. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
heart rate
Measured: during the endoscopy (30-60 minute)
arterial blood pressure
arterial blood pressure
Measured: during the endoscopy (30-60 minute)
oxygen saturation
oxygen saturation
Measured: during the endoscopy (30-60 minute)
end-tidal CO₂
end-tidal CO₂
Measured: during the endoscopy (30-60 minute)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start3 Sep 2025
- Primary completion28 Feb 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DepressionStudies 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
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer Sebnem Turk, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166614
- Sponsor's protocol ID
- turk-25
- Status last verified
- May 2026
- First submitted
- 3 Sep 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Respiratory and Hemodynamic Effects of Dexmedetomidine vs. Propofol in High-Risk Patients Undergoing ERCP: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07166614
- Acronym / sponsor ID
- turk-25
- Keywords
- Dexmedetomidine, propofol, adverse event, ERCP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 10 Sep 2025 (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.
ERCP requires deep sedation due to pain and discomfort, but propofol-commonly used with opioids-often causes respiratory and cardiovascular complications, especially in elderly or high-risk patients. Dexmedetomidine offers sedation without respiratory depression but may lower blood pressure and heart rate. Current monitoring often relies only on SpO₂, while capnography and the Integrated Pulmonary Index (IPI) provide earlier detection of respiratory events but are underused in ERCP studies.
This study compares dexmedetomidine and propofol in high-risk ERCP patients, focusing on respiratory and hemodynamic effects, propofol consumption, recovery, and discharge times. The hypothesis is that dexmedetomidine will cause fewer adverse respiratory and hemodynamic effects.
Detailed description
Endoscopic Retrograde Cholangiopancreatography (ERCP) is uncomfortable and painful for patients. Moreover, immobility is required for procedural success, which necessitates deep sedation. Recently, propofol combined with an opioid has been frequently used for this purpose . However, propofol is associated with respiratory depression, hypoxemia, and hypotension, leading to increased cardiopulmonary complications. These risks become more significant in elderly patients and those with high comorbidity. The use of alternative sedative agents or combinations aims to reduce propofol dosage and minimize cardiopulmonary complications.
Dexmedetomidine is a highly selective α2-adrenoceptor agonist that reduces noradrenergic neuronal activity and is widely used for its sedative and anxiolytic properties. Unlike propofol, dexmedetomidine provides sedation without causing respiratory depression, even at loading doses. Several studies have evaluated the effects of dexmedetomidine and propofol on sedation in gastrointestinal endoscopic procedures . However, dexmedetomidine infusion alone has been shown to be less effective than propofol in terms of sedation quality, and it is associated with significant decreases in blood pressure and heart rate. These adverse events raise concerns regarding the use of dexmedetomidine in high-comorbidity patients requiring stable hemodynamics . Therefore, further studies are needed to evaluate the efficacy and safety of dexmedetomidine versus propofol in high-risk patients undergoing ERCP.
During endoscopy, monitoring of heart rate (HR), arterial blood pressure (BP), and pulse oximetry (SpO₂) is commonly used. Capnography with end-tidal CO₂ (ETCO₂) monitoring enables early detection of hypoventilation and apnea. Accordingly, both national and international guidelines (US and Europe) recommend capnography for monitoring during endoscopic procedures . The Integrated Pulmonary Index (IPI) incorporates HR, respiratory rate, SpO₂, and ETCO₂ parameters into an algorithm (14). It is considered the earliest method for detecting respiratory events and has been shown to be effective during endoscopic sedation.
However, studies evaluating the respiratory effects of sedative agents used in ERCP have been limited to SpO₂ values and adverse events, without assessment of ETCO₂ or IPI parameters.
In the study, the investigator primarily aimed to compare the respiratory and hemodynamic effects of dexmedetomidine versus propofol in high-risk patients undergoing ERCP. Secondarily, we evaluated total propofol consumption, recovery time, and discharge time from the endoscopy unit. Our hypothesis was that dexmedetomidine sedation in high-risk ERCP patients would result in fewer respiratory and hemodynamic side effects compared to propofol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group d | Experimental | Drug: dexmedetomidinA loading dose of dexmedetomidine at 1 μg/kg was administered over 10 minutes prior to the procedure. During the procedure, an infusion at 0.5 μg/kg/h was maintained, which was discontinued at the end of the procedure |
| group p | Active comparator | Drug: PropofolIn our ERCP unit, induction was performed according to the standard protocol using fentanyl 1 µg/kg and propofol 1 mg/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients over 18 years of age
- ASA physical status III-IV
- scheduled for ERCP in the Gastroenterology Endoscopy Unit of our hospital
Key exclusion criteria (5 listed)
- pregnant women;
- patients with neuropsychiatric disease,
- substance abuse, or known allergy to the sedatives used;
- patients with baseline heart rate ≤50 bpm;
- those who did not provide consent.
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 |
|---|---|---|
| dexmedetomidinDexmedetomidine is a highly selective α2-adrenergic receptor agonist with sedative, anxiolytic, and analgesic properties. Unlike many other sedatives, it provides sedation without significant respiratory depression, though it may cause bradycardia and hypotension | Drug | group d |
| PropofolPropofol is a short-acting intravenous anesthetic agent widely used for induction and maintenance of anesthesia as well as procedural sedation. It provides rapid onset and recovery, but is associated with respiratory depression and hypotension | Drug | group p |
Primary outcome
heart rate
Time frame: during the endoscopy (30-60 minute)
heart rate
arterial blood pressure
Time frame: during the endoscopy (30-60 minute)
arterial blood pressure
oxygen saturation
Time frame: during the endoscopy (30-60 minute)
oxygen saturation
end-tidal CO₂
Time frame: during the endoscopy (30-60 minute)
end-tidal CO₂
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexmedetomidin and Propofol in people with Respiratory Depression and Hypoxemia, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate (time frame: during the endoscopy (30-60 minute)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2026.