Anesthesia, GeneralNCT02711280
The Effect of Anesthetics on Oxidative Stress and Apoptosis Status in Children
A study testing Sevoflurane and Propofol in people with Anesthesia, General, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The purpose of this study is to determine whether Propofol and Sevoflurane affect the oxidative stress and apoptosis status in children undergoing hypospadias repair surgery. Read more about this study
- Who is it for?
- Ages 1 year to 3 years, men only
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Sevoflurane and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Jun 2016
- 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 1 year to 3 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiology (ASA) I-II, undergoing selective surgery for hypospadias repair.
Who cannot join
- a history of developmental delay or mental retardation, which could make observational pain intensity assessment outside the norm;
- a history of central nervous system diseases;
- a known or suspected coagulopathy;
- a known allergy to any of the study drugs;
- abnormalities of the sacrum and any signs of infection at the site of the proposed caudal block.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510080
About this study
Official title: The Effect of Sevoflurane and Propofol on Oxidative Stress and Apoptosis Status in Children Undergoing Hypospadias Repair Surgery
The purpose of this study is to determine whether Propofol and Sevoflurane affect the oxidative stress and apoptosis status in children undergoing hypospadias repair surgery.
- Conditions
- Anesthesia, General
- Being tested
- Sevoflurane, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
PropofolDrug
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane General anesthesia | Experimental | Anesthesia was induced with 8% sevoflurane with 8L/min oxygen. Anesthesia was maintained with 1-3% sevoflurane in oxygen/air mixture. Receives: Drug: Sevoflurane |
| Propofol General anesthesia | Experimental | Anesthesia was induced with propofol 4mg/kg. Anesthesia was maintained with propofol 7-12mg/kg/h. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of blood glutathione peroxidase(GPx) level in perioperative period
Measured: immediately after anesthetic induction, 2h and 3 days after operation
the change of blood-separated erythrocytes superoxide dismutase (SOD) activities in perioperative period
the blood sample was separated and erythrocytes was obtained, superoxide dismutase activity was measured using a commercially available assay-Ransod kit (Randox Laboratories, UK).
Measured: immediately after anesthetic induction, 2h and 3 days after operation
the change of blood-separated erythrocytes catalase (CAT) activities in perioperative period
the blood sample was separated and erythrocytes was obtained, catalase activity was measured using the OxiSelect catalase activity assay (Cell Biolabs, San Diego, CA, USA)
Measured: immediately after anesthetic induction, 2h and 3 days after operation
the change of blood-separated lymphocytes caspase-3 mRNA level in perioperative period
Lymphocytes were separated from whole blood and freshly used for real-time PCR of caspase-3
Measured: immediately after anesthetic induction, 2h and 3 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Xia, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Xue Zhou, Master, Principal investigator, Department of Anesthesiology, the First-Affiliated Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711280
- Sponsor's protocol ID
- [2014]114
- Status last verified
- Oct 2016
- First submitted
- 7 Mar 2016
- Last updated
- 12 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sevoflurane and Propofol on Oxidative Stress and Apoptosis Status in Children Undergoing Hypospadias Repair Surgery
- ClinicalTrials.gov ID
- NCT02711280
- Acronym / sponsor ID
- [2014]114
- Conditions
- Anesthesia, General
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Mar 2016 (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.
The purpose of this study is to determine whether Propofol and Sevoflurane affect the oxidative stress and apoptosis status in children undergoing hypospadias repair surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane General anesthesia | Experimental | Drug: SevofluraneAnesthesia was induced with 8% sevoflurane with 8L/min oxygen. Anesthesia was maintained with 1-3% sevoflurane in oxygen/air mixture. |
| Propofol General anesthesia | Experimental | Drug: PropofolAnesthesia was induced with propofol 4mg/kg. Anesthesia was maintained with propofol 7-12mg/kg/h. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- American Society of Anesthesiology (ASA) I-II, undergoing selective surgery for hypospadias repair.
Key exclusion criteria (5 listed)
- a history of developmental delay or mental retardation, which could make observational pain intensity assessment outside the norm;
- a history of central nervous system diseases;
- a known or suspected coagulopathy;
- a known allergy to any of the study drugs;
- abnormalities of the sacrum and any signs of infection at the site of the proposed caudal block.
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 |
|---|---|---|
| Sevoflurane | Drug | Sevoflurane General anesthesia |
| Propofol | Drug | Propofol General anesthesia |
Primary outcome
the change of blood glutathione peroxidase(GPx) level in perioperative period
Time frame: immediately after anesthetic induction, 2h and 3 days after operation
the change of blood-separated erythrocytes superoxide dismutase (SOD) activities in perioperative period
Time frame: immediately after anesthetic induction, 2h and 3 days after operation
the blood sample was separated and erythrocytes was obtained, superoxide dismutase activity was measured using a commercially available assay-Ransod kit (Randox Laboratories, UK).
the change of blood-separated erythrocytes catalase (CAT) activities in perioperative period
Time frame: immediately after anesthetic induction, 2h and 3 days after operation
the blood sample was separated and erythrocytes was obtained, catalase activity was measured using the OxiSelect catalase activity assay (Cell Biolabs, San Diego, CA, USA)
the change of blood-separated lymphocytes caspase-3 mRNA level in perioperative period
Time frame: immediately after anesthetic induction, 2h and 3 days after operation
Lymphocytes were separated from whole blood and freshly used for real-time PCR of caspase-3
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 12 Oct 2016.
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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.
Xue Zhou, Master principal investigator
Department of Anesthesiology, the First-Affiliated Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane and Propofol in people with Anesthesia, General, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 1 inclusion and 5 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 12 Oct 2016. 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 China. 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?
the change of blood glutathione peroxidase(GPx) level in perioperative period (time frame: immediately after anesthetic induction, 2h and 3 days after operation). The study lists 4 primary outcomes in all. 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 12 Oct 2016.