Optimization of Sedation Protocol for Endoscopic Procedures Using Impedance Ventilation Monitor.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Optimization of Sedation Protocol for Endoscopic Procedures Using Impedance Ventilation Monitor.

Conditions
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Sedation Complication, Ventilatory Depression

Intervention / Treatment
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* Drug: Sedation using only Propofol.
* Drug: Sedation using combination of Propofol and Fentanyl.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled therapeutic or diagnostic colonoscopy with sedation Supine or lateral decubitus position Age 18-65 American Society of Anesthesiologists (ASA) physical status classification system 1-2 Informed consent signed Exclusion Criteria: Planned frequent use of electrocoagulation Contact allergy for adhesive pads, excessive thoracic hair or other problem with pads contraindication of using Propofol or Fentanyl Incapability to understand the informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be performed on a sample of patients undergoing an endoscopic procedure requiring sedation. Patients will be divided into two groups, one group will be sedated with propofol only, the other will be premedicated with the opioid analgesic fentanyl before the procedure.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>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.<br>* Patients in whom only propofol will be administered during sedation.<br>* Other names: Propofol;|
| Active Comparator: Fentanyl<br>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.<br>* Patients in whom combination of propofol and fentanyl will be administered during sedation.<br>* Other names: Fentanyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of significant decrease in ventilation during propofol sedation. | Incidence of significant decrease in ventilation during sedation with propofol alone during endoscopic surgery. | 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. | during the endoscopic procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | immediately after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedation protocol, endoscopic procedure, ventilation monitoring, ventilatory depression