Surgical Complications From General AnesthesiaNCT03161275
Measurement of the Cerebral Saturation for Assessment of Safety of Epidural Anaesthesia During Abdominal Surgery
An observational study of Surgical Complications From General Anesthesia and Cerebral Ischemia, run by Jagiellonian University at 1 site in Poland.
Trial summary
Subsequent and non-randomised patients, adult patients qualified for major abdominal surgeries were enrolled Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Surgical Complications From General Anesthesia, Cerebral Ischemia, Anesthesia; Reaction
- How many people
- 101 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2012to Apr 2013
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: One hundred and one (101) subsequent and non-randomised patients, age between 35 and 84 years (mean 64±10) hospitalised at the 1st Department of General, Oncologic and Gastroenterologic Surgery of the UJ CM in Krakow, qualified for abdominal surgeries were enrolled.
Who may be able to join
- scheduled for major abdominal surgery for at least 2 h
- under general anesthesia
- American Society of Anesthesiologists（ASA）physical status : II ~ III
- Age > 18
Who cannot join
- refuse of patients
- patient with results of test: "The Mini Mental State Examination"" less then 24 before operation
- neurosurgery history of patients
Trial locations and contacts
1 site in 1 country.
About this study
Subsequent and non-randomised patients, adult patients qualified for major abdominal surgeries were enrolled
- Keywords
- cerebral saturation, epidural anaesthesia, Near Infrared Spectroscopy (NIRS), Regional cerebral oxygen saturation
- Medical subject headings
- Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| nirs | The cerebral oxymetry saturation was monitored continuously, using a non-invasive method. The cerebral saturation was monitored intraoperatively with near infrared spectroscopy (INVOS 4100; Somanetics Inc, Troy, MI). Data acquired from the device were automatically and continuously recorded in 10-second intervals throughout the anaesthesia. A lead for the cerebral saturation monitoring was placed on degreased skin on the patient's forehead, on the right side, some 1 cm over the eyebrow. The baseline value was determined before induction of anaesthesia. The following criteria were accepted as significant reduction of the cerebral oxygenation (saturation) value: reduction of the cerebral oxymetry by over 25% in relation to the baseline; the absolute value of cerebral oxymetry below 50%. | |
| cognitive function | Upon the day preceding the actual surgery, and again at 5 days after the surgery, the Mini Mental State Examination test was completed, with a view to assessing the chang-es in the patients' cognitive function. The difference between score in Mini Mental State Examination higher than 2 points defined a diagnosis of cognitive dysfunction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral saturation
decreases in cerebral oxygen saturation (rSO2) during the surgery
Measured: every 5 minutes throughout the surgery
Secondary outcomes (1)
the Mini Mental State Examination test
to assessing the changes in the patients' cognitive function
Measured: Baseline, 4 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study startJul 2012
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Complications From General AnesthesiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Skladzien, Jagiellonian University
- Investigators
- Tomasz Składzień, Ph.D, Study chair, University Hospital in Cracow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161275
- Sponsor's protocol ID
- K/ZDS/002839
- Status last verified
- May 2017
- First submitted
- 16 May 2016
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 1. The day before the surgery will be performed basic blood tests (morphology, gas analysis) and test "Short Scale Mental State Examination." 2. During the operation, in addition to standard monitoring the electrical activity of the heart, blood pressure and peripheral oxygen saturation levels, will be assessed non-invasively cerebral oximetry. 3. When during general anesthesia bradycardia occurs, then half of the patients in this group will be set up into the esophagus electrode, which will provide the ability to route atrial pacing hemodynamically optimal heart rate (80 / min). However, in the second half of the patients at the time of the occurrence of bradycardia is given intravenously at a dose of atropine 0.5 mg. 4. In about two hours after the surgery will be taken blood tests (morphology + gas analysis) to determine the potential impact of intraoperative bleeding changes oximetry. 5. On postoperative day 5 will be repeated test "Short Scale Mental State Examination"
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Cerebral Saturation for Assessment of Safety of Epidural Anaesthesia During Abdominal Surgery
- ClinicalTrials.gov ID
- NCT03161275
- Acronym / sponsor ID
- K/ZDS/002839
- Keywords
- cerebral saturation, epidural anaesthesia, Near Infrared Spectroscopy (NIRS), Regional cerebral oxygen saturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 19 May 2017 (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.
Subsequent and non-randomised patients, adult patients qualified for major abdominal surgeries were enrolled
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nirs | – | –The cerebral oxymetry saturation was monitored continuously, using a non-invasive method. The cerebral saturation was monitored intraoperatively with near infrared spectroscopy (INVOS 4100; Somanetics Inc, Troy, MI). Data acquired from the device were automatically and continuously recorded in 10-second intervals throughout the anaesthesia. A lead for the cerebral saturation monitoring was placed on degreased skin on the patient's forehead, on the right side, some 1 cm over the eyebrow. The baseline value was determined before induction of anaesthesia. The following criteria were accepted as significant reduction of the cerebral oxygenation (saturation) value: reduction of the cerebral oxymetry by over 25% in relation to the baseline; the absolute value of cerebral oxymetry below 50%. |
| cognitive function | – | –Upon the day preceding the actual surgery, and again at 5 days after the surgery, the Mini Mental State Examination test was completed, with a view to assessing the chang-es in the patients' cognitive function. The difference between score in Mini Mental State Examination higher than 2 points defined a diagnosis of cognitive dysfunction. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred and one (101) subsequent and non-randomised patients, age between 35 and 84 years (mean 64±10) hospitalised at the 1st Department of General, Oncologic and Gastroenterologic Surgery of the UJ CM in Krakow, qualified for abdominal surgeries were enrolled.
Key inclusion criteria (4 listed)
- scheduled for major abdominal surgery for at least 2 h
- under general anesthesia
- American Society of Anesthesiologists（ASA）physical status : II ~ III
- Age > 18
Key exclusion criteria (3 listed)
- refuse of patients
- patient with results of test: "The Mini Mental State Examination"" less then 24 before operation
- neurosurgery history 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.
Primary outcome
cerebral saturation
Time frame: every 5 minutes throughout the surgery
decreases in cerebral oxygen saturation (rSO2) during the surgery
1 secondary outcome
the Mini Mental State Examination test
Time frame: Baseline, 4 day after surgery
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 19 May 2017.
- Individual participant dataSharing planned: No. 1. The day before the surgery will be performed basic blood tests (morphology, gas analysis) and test "Short Scale Mental State Examination." 2. During the operation, in addition to standard monitoring the electrical activity of the heart, blood pressure and peripheral oxygen saturation levels, will be assessed non-invasively cerebral oximetry. 3. When during general anesthesia bradycardia occurs, then half of the patients in this group will be set up into the esophagus electrode, which will provide the ability to route atrial pacing hemodynamically optimal heart rate (80 / min). However, in the second half of the patients at the time of the occurrence of bradycardia is given intravenously at a dose of atropine 0.5 mg. 4. In about two hours after the surgery will be taken blood tests (morphology + gas analysis) to determine the potential impact of intraoperative bleeding changes oximetry. 5. On postoperative day 5 will be repeated test "Short Scale Mental State Examination"
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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.
Tomasz Składzień, Ph.D study chair
University Hospital in Cracow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Complications From General Anesthesia and Cerebral Ischemia, run by Jagiellonian University at 1 site in Poland.
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 4 inclusion and 3 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 19 May 2017. 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 Poland. 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?
cerebral saturation (time frame: every 5 minutes throughout the surgery). 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 19 May 2017.