An interventional study of Sedation using only Propofol. and Sedation using combination of Propofol and Fentanyl. in Sedation Complication and Ventilatory Depression, sponsored by Charles University, Czech Republic. Completed at 1 site in Czechia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by Charles University, Czech Republic · Not applicable, Interventional, and Supportive care
The aim of the study is to evaluate the effect of opioids administered during sedation on patients' respiratory activity (ventilation) and comfort of the operator and patient during the endoscopic procedure. A common side effect of sedation is the effect on patients' ventilation, resulting from a combination of attenuation of respiratory centre activity and loss of patent airways. Shallow sedation will reduce these risks, but in addition to patient discomfort, it also increases the difficulty or impossibility of the endoscopist to perform the procedure. Choosing the appropriate method of sedation thus fundamentally affects the course of the procedure from the point of view of both the patient and the endoscopist. The aim is to prove that sedation with propofol alone compared to sedation with propofol and fentanyl premedication leads to the need for higher cumulative doses of administered propofol, higher risk of respiratory depression and lower patient and operator comfort. In addition, the non-invasive respiratory volume monitor (ExSpiron 2Xi) will be used for standard patient monitoring during the procedure, which assesses the lung tidal volume and respiratory rate by measuring the electrical impedance of the chest. This measurement captures inadequate ventilation before saturation drops, allowing even slight differences between selected drugs to be compared.
The aim of the study is to evaluate the effect of opioids administered during sedation on patients' respiratory activity (ventilation) and comfort of the operator and patient during the endoscopic procedure. A common side effect of sedation is the effect on patients' ventilation, resulting from a combination of attenuation of respiratory centre activity and loss of patent airways. Shallow sedation will reduce these risks, but in addition to patient discomfort, it also increases the difficulty or impossibility of the endoscopist to perform the procedure. Choosing the appropriate method of sedation thus fundamentally affects the course of the procedure from the point of view of both the patient and the endoscopist. The aim is to prove that sedation with propofol alone compared to sedation with propofol and fentanyl premedication leads to the need for higher cumulative doses of administered propofol, higher risk of respiratory depression and lower patient and operator comfort. Standard monitoring during endoscopic procedures using sedation includes continual recording of ECG and respiratory rate (using the same electrodes), measurement of arterial blood oxygen saturation using a pulse oximeter and blood pressure measurement. Extended monitoring of spontaneous ventilation during sedation includes analysis of the concentration of exhaled carbon dioxide or analysis of the arterial blood gases.However, these methods have limitations and often critically reduced respiratory activity is diagnosed too late. Impedance monitoring of ventilation is now being introduced into clinical practice. In addition, the non-invasive respiratory volume monitor (ExSpiron 2Xi) will be used for standard patient monitoring during the procedure, which assesses the lung tidal volume and respiratory rate by measuring the electrical impedance of the chest. This measurement captures inadequate ventilation before saturation drops, allowing even slight differences between selected drugs to be compared.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 50 is close to the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Charles University, Czech Republic is the lead sponsor of 220 studies on the registry; 76 are open to participants now.
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Exclusion Criteria:
Patients in whom only propofol will be administered during sedation. Intermittent boluses of propofol titrated to moderate level of sedation.
Drug: Sedation using only Propofol.
Patients in whom combination of propofol and fentanyl will be administered during sedation. Fentanyl 1 ug/kg bolus 3 minutes before induction + Propofol intermittent boluses titrated to moderate level of sedation.
Drug: Sedation using combination of Propofol and Fentanyl.
Patients in whom only propofol will be administered during sedation.
Also known as: Propofol
Patients in whom combination of propofol and fentanyl will be administered during sedation.
Also known as: Fentanyl
Incidence of significant decrease in ventilation during propofol sedation.
Incidence of significant decrease in ventilation during sedation with propofol alone during endoscopic surgery.
Time frame: during the endoscopic procedure
Incidence of significant decrease in ventilation during propofol and fentanyl sedation.
Incidence of significant decrease in ventilation during sedation with propofol and fentanyl during endoscopic surgery.
Time frame: during the endoscopic procedure
Subjective assessment of the comfort of the procedure by the endoscopist.
Subjective assessment of the comfort of the procedure by the endoscopist using a questionnaire.
Time frame: immediately after the procedure
Subjective assessment of the comfort of the procedure by the patient.
Subjective assessment of the comfort of the procedure by the patient using a questionnaire.
Time frame: immediately after the procedure
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Charles University, Czech Republic