An interventional study of dexmedetomidin and Propofol in Respiratory Depression, Hypoxemia and Hypotension Drug-Induced, sponsored by Sisli Hamidiye Etfal Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Sisli Hamidiye Etfal Training and Research Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 100 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
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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
Drug: dexmedetomidin
In our ERCP unit, induction was performed according to the standard protocol using fentanyl 1 µg/kg and propofol 1 mg/kg.
Drug: Propofol
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
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
heart rate
heart rate
Time frame: during the endoscopy (30-60 minute)
arterial blood pressure
arterial blood pressure
Time frame: during the endoscopy (30-60 minute)
oxygen saturation
oxygen saturation
Time frame: during the endoscopy (30-60 minute)
end-tidal CO₂
end-tidal CO₂
Time frame: during the endoscopy (30-60 minute)
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Sisli Hamidiye Etfal Training and Research Hospital