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Completed

NCT Number: NCT06060626

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Military University Hospital Prague

Prague, Czechia, 16209

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sedation using only Propofol.

Drug

Patients in whom only propofol will be administered during sedation.

Other names: Propofol

Sedation using combination of Propofol and Fentanyl.

Drug

Patients in whom combination of propofol and fentanyl will be administered during sedation.

Other names: Fentanyl

Primary outcomes

  1. Incidence of significant decrease in ventilation during propofol sedation.

    Time frame: during the endoscopic procedure

    Incidence of significant decrease in ventilation during sedation with propofol alone during endoscopic surgery.

  2. Incidence of significant decrease in ventilation during propofol and fentanyl sedation.

    Time frame: during the endoscopic procedure

    Incidence of significant decrease in ventilation during sedation with propofol and fentanyl during endoscopic surgery.

Secondary outcomes

  1. Subjective assessment of the comfort of the procedure by the endoscopist.

    Time frame: immediately after the procedure

    Subjective assessment of the comfort of the procedure by the endoscopist using a questionnaire.

  2. Subjective assessment of the comfort of the procedure by the patient.

    Time frame: immediately after the procedure

    Subjective assessment of the comfort of the procedure by the patient using a questionnaire.

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

  • Military University Hospital, Prague

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2023
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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