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

Summary

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.

Conditions

• Sedation Complication
• Ventilatory Depression

Interventions

DRUG

Sedation using only Propofol.

Patients in whom only propofol will be administered during sedation.

DRUG

Sedation using combination of Propofol and Fentanyl.

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

Sponsors & Collaborators

• Military University Hospital, Prague

  collaborator OTHER

• Charles University, Czech Republic

  lead OTHER

Principal Investigators

• Ilona Trtíková, Mgr., Ph.D. · CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE

• David Novotný, M.D. · CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE

• Tomáš Tyll, M.D., Ph.D. · CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE

• Michal Soták, M.D., Ph.D. · CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-16

Primary Completion

2025-01-22

Completion

2025-01-22

Countries

• Czechia

Study Locations