End-tidal SevofluraneNCT05778968
Etco2 Levels on the End-tidal Concentration of Sevoflurane
A study testing low etco2, normal etco2 and high etco2 in people with End-tidal Sevoflurane and End-tidal Carbon Dioxide, run by Tanta University at 1 site in Egypt.
Trial summary
he assessment of adequate levels of anaesthesia traditionally relies not only on a patient's movement but also on the hemodynamic response (or both) to a surgical stimulus Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- End-tidal Sevoflurane, End-tidal Carbon Dioxide, Minimum Alveolar Concentration
- What is being tested?
- low etco2, normal etco2 and high etco2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 29 Jul 2024
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of anaesthesiologist ASA physical status I, II
- admitted for laparoscopic cholecystectomy
Who cannot join
- Refusal of patients.
- Patients with renal or liver dysfunction.
- Patients with chronic pain other than cholelithiasis.
- Cardiac disorders as uncontrolled hypertension, arrhythmia, Ischaemic heart disease, valvular heart disease and pulmonary hypertension.
- Patient with haematological disorder as Sickle cell disease.
- Chest patient as asthma, COPD.
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- Combined surgery .
- History of allergy to any of the study drugs.
- Patients with communication problems, cognitive dysfunction, or psychological disorders.
- Patients who received analgesics or sedatives 24 h before a scheduled surgery.
- Alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Etco2 Levels on the End-tidal Concentration of Sevoflurane in Patients Undergoing Laparoscopic Cholecystectomy
he assessment of adequate levels of anaesthesia traditionally relies not only on a patient's movement but also on the hemodynamic response (or both) to a surgical stimulus
Read the detailed description
Currently a derivative of MAC namely, end tidal partial pressure (FET) displayed on the work station as concentration , maybe an alternative useful measure of the anaesthetic effect of an inhaled anaesthetic agent
. Many pharmacological factors have been associated with alterations in MAC and Mac derivatives such as nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, and anesthetics.
However, few studies have focused on physiological factors, such as hypercarbia or hypocarbia. A correlation has been found between Paco2 and Etco2 in ventilated patients with healthy lungs. Some authors have suggested that Etco2 could be considered appropriate for estimating Paco2 even in critical patients. Knowledge of the effects of Paco2 on end tidal concentration of sevoflurane among patients undergoing laparoscopic cholecystectomy may help anaesthesiologists titrate sevoflurane carefully and precisely during different mechanical ventilation settings to avoid dose-dependent hypotension, impaired cardiac contractility, and hypothermia caused by excessive anaesthetic depth of sevoflurane.
- Being tested
- low etco2, normal etco2, high etco2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low etco2Procedure or surgery
Etco2 levels will be adjusted at levels ranging between 25 mm Hg and 30 mm Hg
normal etco2Procedure or surgery
Etco2 levels will be adjusted at levels ranging between 31 mm Hg and 40 mm Hg
high etco2Procedure or surgery
Etco2 levels will be adjusted at levels ranging between 41 mm Hg and 45 mm Hg
| Study group | Role | What they receive |
|---|---|---|
| low ETCO2 | Active comparator | Not described Receives: Procedure: low etco2 |
| normal ETCO2 | Active comparator | Not described Receives: Procedure: normal etco2 |
| high ETCO2 | Active comparator | Not described Receives: Procedure: high etco2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
end tidal concentration of sevoflurane
end tidal concentration of sevoflurane is measured by multiple gas analyser during operation
Measured: Total time of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Feb 2023
- Primary completion1 Jun 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-tidal SevofluraneStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tarek abdel hay mostafa, Tanta University
- Investigators
- thanaa elnomany, MD, Study director, tanta university, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778968
- Sponsor's protocol ID
- MAC of sevoflurane
- Status last verified
- Jul 2024
- First submitted
- 8 Mar 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Etco2 Levels on the End-tidal Concentration of Sevoflurane in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT05778968
- Acronym / sponsor ID
- MAC of sevoflurane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 22 Mar 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.
he assessment of adequate levels of anaesthesia traditionally relies not only on a patient's movement but also on the hemodynamic response (or both) to a surgical stimulus
Detailed description
Currently a derivative of MAC namely, end tidal partial pressure (FET) displayed on the work station as concentration , maybe an alternative useful measure of the anaesthetic effect of an inhaled anaesthetic agent
. Many pharmacological factors have been associated with alterations in MAC and Mac derivatives such as nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, and anesthetics.
However, few studies have focused on physiological factors, such as hypercarbia or hypocarbia. A correlation has been found between Paco2 and Etco2 in ventilated patients with healthy lungs. Some authors have suggested that Etco2 could be considered appropriate for estimating Paco2 even in critical patients. Knowledge of the effects of Paco2 on end tidal concentration of sevoflurane among patients undergoing laparoscopic cholecystectomy may help anaesthesiologists titrate sevoflurane carefully and precisely during different mechanical ventilation settings to avoid dose-dependent hypotension, impaired cardiac contractility, and hypothermia caused by excessive anaesthetic depth of sevoflurane.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low ETCO2 | Active comparator | Procedure: low etco2 |
| normal ETCO2 | Active comparator | Procedure: normal etco2 |
| high ETCO2 | Active comparator | Procedure: high etco2 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of anaesthesiologist ASA physical status I, II
- admitted for laparoscopic cholecystectomy
Key exclusion criteria (11 listed)
- Refusal of patients.
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 |
|---|---|---|
| low etco2Etco2 levels will be adjusted at levels ranging between 25 mm Hg and 30 mm Hg | Procedure or surgery | low ETCO2 |
| normal etco2Etco2 levels will be adjusted at levels ranging between 31 mm Hg and 40 mm Hg | Procedure or surgery | normal ETCO2 |
| high etco2Etco2 levels will be adjusted at levels ranging between 41 mm Hg and 45 mm Hg | Procedure or surgery | high ETCO2 |
Primary outcome
end tidal concentration of sevoflurane
Time frame: Total time of operation
end tidal concentration of sevoflurane is measured by multiple gas analyser during operation
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 30 Jul 2024.
- Individual participant dataSharing planned: No
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.
thanaa elnomany, MD study director
tanta university, faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low etco2, normal etco2 and high etco2 in people with End-tidal Sevoflurane and End-tidal Carbon Dioxide, run by Tanta University at 1 site in Egypt.
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 2 inclusion and 11 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 30 Jul 2024. 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 Egypt. 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?
end tidal concentration of sevoflurane (time frame: Total time of operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2024.