Sedation ComplicationNCT06060626
Optimization of Sedation Protocol for Endoscopic Procedures Using Impedance Ventilation Monitor.
A study testing Sedation using only Propofol. and Sedation using combination of Propofol and Fentanyl. in people with Sedation Complication and Ventilatory Depression, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sedation Complication, Ventilatory Depression
- What is being tested?
- Sedation using only Propofol. and Sedation using combination of Propofol and Fentanyl.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 16 Nov 2023to 22 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
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. 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.
Read the detailed description
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.
- Conditions
- Sedation Complication, Ventilatory Depression
- Being tested
- Sedation using only Propofol., Sedation using combination of Propofol and Fentanyl.
- Keywords
- sedation protocol, endoscopic procedure, ventilation monitoring, ventilatory depression
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation using only Propofol.Drug
Also called Propofol
Patients in whom only propofol will be administered during sedation.
Sedation using combination of Propofol and Fentanyl.Drug
Also called Fentanyl
Patients in whom combination of propofol and fentanyl will be administered during sedation.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Patients in whom only propofol will be administered during sedation. Intermittent boluses of propofol titrated to moderate level of sedation. Receives: Drug: Sedation using only Propofol. |
| Fentanyl | Active comparator | 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. Receives: Drug: Sedation using combination of Propofol and Fentanyl. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of significant decrease in ventilation during propofol sedation.
Incidence of significant decrease in ventilation during sedation with propofol alone during endoscopic surgery.
Measured: 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.
Measured: during the endoscopic procedure
Secondary outcomes (2)
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.
Measured: 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.
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start16 Nov 2023
- Primary completion22 Jan 2025
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sedation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Military University Hospital, Prague
- Responsible party
- Sponsor
- Investigators
- Ilona Trtíková, Mgr., Ph.D., Study chair, CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUEDavid Novotný, M.D., Principal investigator, CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUETomáš Tyll, M.D., Ph.D., Principal investigator, CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUEMichal Soták, M.D., Ph.D., Principal investigator, CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060626
- Sponsor's protocol ID
- ExSpironUVN
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bai Y, Xu Z, Chandrashekar M, St Jacques PJ, Liang Y, Jiang Y, Kla K. Comparison of a simplified nasal continuous positive airways pressure device with nasal cannula in obese patients undergoing colonoscopy during deep sedation: A randomised clinical trial. Eur J Anaesthesiol. 2019 Sep;36(9):633-640. doi: 10.1097/EJA.0000000000001052.
PubMed 31313720Zhang X, Kassem MA, Zhou Y, Shabsigh M, Wang Q, Xu X. A Brief Review of Non-invasive Monitoring of Respiratory Condition for Extubated Patients with or at Risk for Obstructive Sleep Apnea after Surgery. Front Med (Lausanne). 2017 Mar 8;4:26. doi: 10.3389/fmed.2017.00026. eCollection 2017.
PubMed 28337439Voscopoulos CJ, MacNabb CM, Brayanov J, Qin L, Freeman J, Mullen GJ, Ladd D, George E. The evaluation of a non-invasive respiratory volume monitor in surgical patients undergoing elective surgery with general anesthesia. J Clin Monit Comput. 2015 Apr;29(2):223-30. doi: 10.1007/s10877-014-9596-0. Epub 2014 Jul 19.
PubMed 25037938
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Sedation Protocol for Endoscopic Procedures Using Impedance Ventilation Monitor.
- ClinicalTrials.gov ID
- NCT06060626
- Acronym / sponsor ID
- ExSpironUVN
- Conditions
- Sedation Complication, Ventilatory Depression
- Keywords
- sedation protocol, endoscopic procedure, ventilation monitoring, ventilatory depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Military University Hospital, Prague
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: Sedation using only Propofol.Patients in whom only propofol will be administered during sedation. Intermittent boluses of propofol titrated to moderate level of sedation. |
| Fentanyl | Active comparator | Drug: Sedation using combination of Propofol and Fentanyl.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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedation using only Propofol.Also: PropofolPatients in whom only propofol will be administered during sedation. | Drug | Propofol |
| Sedation using combination of Propofol and Fentanyl.Also: FentanylPatients in whom combination of propofol and fentanyl will be administered during sedation. | Drug | Fentanyl |
Primary outcome
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.
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.
2 secondary outcomes
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 patient.
Time frame: immediately after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Background: PubMed 31313720Bai Y, Xu Z, Chandrashekar M, St Jacques PJ, Liang Y, Jiang Y, Kla K. Comparison of a simplified nasal continuous positive airways pressure device with nasal cannula in obese patients undergoing colonoscopy during deep sedation: A randomised clinical trial. Eur J Anaesthesiol. 2019 Sep;36(9):633-640. doi: 10.1097/EJA.0000000000001052.
- Results publication: PubMed 28337439Zhang X, Kassem MA, Zhou Y, Shabsigh M, Wang Q, Xu X. A Brief Review of Non-invasive Monitoring of Respiratory Condition for Extubated Patients with or at Risk for Obstructive Sleep Apnea after Surgery. Front Med (Lausanne). 2017 Mar 8;4:26. doi: 10.3389/fmed.2017.00026. eCollection 2017.
- Results publication: PubMed 25037938Voscopoulos CJ, MacNabb CM, Brayanov J, Qin L, Freeman J, Mullen GJ, Ladd D, George E. The evaluation of a non-invasive respiratory volume monitor in surgical patients undergoing elective surgery with general anesthesia. J Clin Monit Comput. 2015 Apr;29(2):223-30. doi: 10.1007/s10877-014-9596-0. Epub 2014 Jul 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilona Trtíková, Mgr., Ph.D. study chair
CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE
David Novotný, M.D. principal investigator
CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE
Tomáš Tyll, M.D., Ph.D. principal investigator
CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND MILITARY UNIVERSITY HOSPITAL PRAGUE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedation using only Propofol. and Sedation using combination of Propofol and Fentanyl. in people with Sedation Complication and Ventilatory Depression, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of significant decrease in ventilation during propofol sedation. (time frame: during the endoscopic procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06060626, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.