AnesthesiaNCT02056561
Effects on Immun System of Anesthesia
An observational study of Anesthesia, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
Introduction and Aim: Desflurane and sevoflurane are frequently used for maintenance of anesthesia and studies have shown that these anesthetics cause a variety of changes in oxidative stress and antioxidative defense mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- Type of treatment
- Injection or infusion
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2010to Jan 2011
- How long will I take part?
- 3 Days
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 45 patients ASA I-II between 18-50 years with planned laparoscopic cholecystectomy under general anesthetic were included in the study. Patients were divided into 3 groups on the way to surgery; TIVA (group T n: 15), sevoflurane (group S n: 15) and desflurane (group D n: 15).
Who may be able to join
- ASA I-II with patients
- Between 18-50 years
- Planned laparoscopic cholecystectomy under general anesthetic
Who cannot join
- Patients with endocrine dysfunction
- blood transfusion in the previous 2 weeks
- signs of infection and inflammation
- history of preoperative medication use
- anemia
- hemorrhage requiring transfusion during the operation were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duzce Univercity Medical Fauculty
Düzce, 81600
About this study
Official title: Investigation Of The Effects Of General Anesthesia On The Oxidant/Antioxidant System
Introduction and Aim: Desflurane and sevoflurane are frequently used for maintenance of anesthesia and studies have shown that these anesthetics cause a variety of changes in oxidative stress and antioxidative defense mechanisms. The chemical structure of propofol is similar to some free radical consumers such as endogenous vitamin E and butylated hydroxene toluene. This study aims to compare the effects of sevoflurane, desflurane and propofol infusion anesthesia on the oxidant and antioxidant systems of patients undergoing laparoscopic cholecystectomy.
Material and Method: Forty-five patients, ASA (American Society of Anesthesiologists) I-II, score between 18-50 years with planned laparoscopic cholecystectomy under general anesthesia were included in the study. Patients were divided into 3 groups as total intravenous anesthesia (TIVA) (group T n: 15), sevoflurane (group S n: 15) and desflurane (group D n: 15). Propofol 2 mg/kg IV, fentanyl 1 mcg/kg IV, vecuronium 0.1 mg/kg IV given to all groups for anesthesia induction. For maintenance of anesthesia group S were ventilated with 2% sevoflurane, 50% air and 50% O2 mix at 6 L/min flow. Group D were given 6% desflurane 50% air and 50% O2 mix at 6 L/min flow. Group T were given propofol infusions of 12 mg/kg/hr for the first 10 minutes, 9 mg/kg/hr for the second 10 minutes and 6 mg/kg/hr after that. Patients were ventilated with 50% air and 50% O2 mix at 6 L/min flow. Before induction and after the operation venous blood samples were taken to evaluate the levels of glutathion peroxidase, total oxidants and antioxidants.
- Conditions
- Anesthesia
- Keywords
- Anesthesia, Oxidants, Antioxidants
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 |
|---|---|---|
| TIVA (group T n: 15) | Group T were given propofol infusions of 12 mg/kg/hr for the first 10 minutes, 9 mg/kg/hr for the second 10 minutes and 6 mg/kg/hr after that. Patients were ventilated with 50% air and 50% O2 mix at 6 L/min flow. | |
| Sevoflurane (group S n: 15) | Group S were ventilated with 2% sevoflurane, 50% air and 50% O2 mix at 6 L/min flow. | |
| Desflurane (group D n: 15) | Group D cases were given 6% desflurane 50% air and 50% O2 mix at 6 L/min flow. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of glutathion peroxidase, total oxidants and antioxidants.
Before induction and after the operation venous blood samples were taken to evaluate the levels of glutathion peroxidase, total oxidants and antioxidants.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yavuz demiraran, Duzce University
- Investigators
- yavuz demiraran, MD prof, Principal investigator, duzce university medical faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056561
- Sponsor's protocol ID
- MESUT-81
- Status last verified
- Feb 2014
- First submitted
- 29 Jan 2014
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Of The Effects Of General Anesthesia On The Oxidant/Antioxidant System
- ClinicalTrials.gov ID
- NCT02056561
- Acronym / sponsor ID
- MESUT-81
- Conditions
- Anesthesia
- Keywords
- Anesthesia, Oxidants, Antioxidants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 Feb 2014 (estimated)
- 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.
Introduction and Aim: Desflurane and sevoflurane are frequently used for maintenance of anesthesia and studies have shown that these anesthetics cause a variety of changes in oxidative stress and antioxidative defense mechanisms. The chemical structure of propofol is similar to some free radical consumers such as endogenous vitamin E and butylated hydroxene toluene. This study aims to compare the effects of sevoflurane, desflurane and propofol infusion anesthesia on the oxidant and antioxidant systems of patients undergoing laparoscopic cholecystectomy.
Material and Method: Forty-five patients, ASA (American Society of Anesthesiologists) I-II, score between 18-50 years with planned laparoscopic cholecystectomy under general anesthesia were included in the study. Patients were divided into 3 groups as total intravenous anesthesia (TIVA) (group T n: 15), sevoflurane (group S n: 15) and desflurane (group D n: 15). Propofol 2 mg/kg IV, fentanyl 1 mcg/kg IV, vecuronium 0.1 mg/kg IV given to all groups for anesthesia induction. For maintenance of anesthesia group S were ventilated with 2% sevoflurane, 50% air and 50% O2 mix at 6 L/min flow. Group D were given 6% desflurane 50% air and 50% O2 mix at 6 L/min flow. Group T were given propofol infusions of 12 mg/kg/hr for the first 10 minutes, 9 mg/kg/hr for the second 10 minutes and 6 mg/kg/hr after that. Patients were ventilated with 50% air and 50% O2 mix at 6 L/min flow. Before induction and after the operation venous blood samples were taken to evaluate the levels of glutathion peroxidase, total oxidants and antioxidants.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TIVA (group T n: 15) | – | –Group T were given propofol infusions of 12 mg/kg/hr for the first 10 minutes, 9 mg/kg/hr for the second 10 minutes and 6 mg/kg/hr after that. Patients were ventilated with 50% air and 50% O2 mix at 6 L/min flow. |
| Sevoflurane (group S n: 15) | – | –Group S were ventilated with 2% sevoflurane, 50% air and 50% O2 mix at 6 L/min flow. |
| Desflurane (group D n: 15) | – | –Group D cases were given 6% desflurane 50% air and 50% O2 mix at 6 L/min flow. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 45 patients ASA I-II between 18-50 years with planned laparoscopic cholecystectomy under general anesthetic were included in the study. Patients were divided into 3 groups on the way to surgery; TIVA (group T n: 15), sevoflurane (group S n: 15) and desflurane (group D n: 15).
Key inclusion criteria (3 listed)
- ASA I-II with patients
- Between 18-50 years
- Planned laparoscopic cholecystectomy under general anesthetic
Key exclusion criteria (6 listed)
- Patients with endocrine dysfunction
- blood transfusion in the previous 2 weeks
- signs of infection and inflammation
- history of preoperative medication use
- anemia
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
Levels of glutathion peroxidase, total oxidants and antioxidants.
Time frame: 24 hours
Before induction and after the operation venous blood samples were taken to evaluate the levels of glutathion peroxidase, total oxidants and antioxidants.
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 6 Feb 2014.
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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.
yavuz demiraran, MD prof principal investigator
duzce university medical faculty
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 Anesthesia, run by Duzce University at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 6 Feb 2014. 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 Turkey (Türkiye). 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?
Levels of glutathion peroxidase, total oxidants and antioxidants. (time frame: 24 hours). 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 6 Feb 2014.