Anesthetic ToxicityNCT03746340
The Effects of Different General Anesthetics on Serum Folic Acid and Homocysteine Concentrations in Children
An observational study of Anesthetic Toxicity, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
The concentration of folic acid and homocysteine in the blood can be used as independent risk factors for a variety of diseases. A sustained decrease in blood folate concentration and an increase in homocysteine concentration can damage vascular endothelial cells, causing varying degrees of neurodevelopmental… Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Anesthetic Toxicity
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2018to 31 Mar 2019
- 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 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Children under 3 years old who underwent general anesthesia
Who may be able to join
- Children under 3 years old who underwent general anesthesia
- Those who did not participate in other clinical trials within 3 months
- No acute infectious diseases, systemic diseases
- The family member of the child agrees to the test and signs the informed consent form.
Who cannot join
- Refusal to join the group
- severe liver and kidney damage
- Hemodynamic instability (shock, blood pressure drop > 30% of basal blood pressure)
- Children with egg and milk allergy
- Children with a family history of malignant hyperthermia
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital , Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
About this study
The concentration of folic acid and homocysteine in the blood can be used as independent risk factors for a variety of diseases. A sustained decrease in blood folate concentration and an increase in homocysteine concentration can damage vascular endothelial cells, causing varying degrees of neurodevelopmental abnormalities. Many clinical studies have found that anesthetics can affect blood folate and homocysteine concentration, but the effects of sevoflurane and propofol on blood folate and homocysteine concentrations are not clear. Therefore, this study aims to investigate the effects of sevoflurane and propofol on blood folate and homocysteine levels in children.
Read the detailed description
Retrospective study: Study the medical history of infants and young children (less than 3 years old) who underwent sevoflurane or propofol general anesthesia for more than 3 hours from January 2018 to December 2018, and compare the preoperative and postoperative serum folate changes for retrospective analysis.
Prospective study：Ten infants and young children (less than 3 years old) who underwent general anesthesia from November 7, 2018 to December 31, 2018 in Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. Inhalation of 1-8% concentration of sevoflurane for general anesthesia induced intubation, followed by sevoflurane 2.0 ~ 2.5 Vol% inhalation maintenance, according to the intraoperative situation to add opioids. Patients maintained a bispectral index (BIS) monitoring between 50 and 60. After induction of general anesthesia in all patients, Serum folate levels were measured before the start of surgery, every 1 hour during surgery, and at the end of surgery.
- Conditions
- Anesthetic Toxicity
- Being tested
- Propofol, Sevoflurane
- Keywords
- sevoflurane, propofol, Folic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol group: intravenous Propofol (2.0mg / kg) for general anesthesia induction, maintained for 30~60s. Continuous intravenous infusion of Propofol (7~8 mg·kg-1·h-1) with a syringe pump maintains a smooth general anesthetic sedative effect.
SevofluraneDrug
Sevoflurane group: Inhalation of 1-8% sevoflurane for induction.Then Inhalation of sevoflurane (2.0~2.5Vol%) was maintained
| Study group | Role | What they receive |
|---|---|---|
| Anesthetic | Sevoflurane Group Propofol Group Receives: Drug: Propofol; Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of folate in the perioperative serum
a Chemiluminescent Microparticle Folate Binding Protein assay with the ARCHITECT Folate Reagent Kit (Abbott Laboratories, IL, USA) was used to determine serum folate concentrations. Serum folate concentrations were quantified using the ARCHITECT i2000 SR System (Abbott Laboratories).
Measured: Change of serum folate levels from the beginning of anesthesia to the end.Serum folate levels were measured at admission, after 1 hours,after 2 hours,after 3 hours.
levels of homocysteine in the perioperative serum
Serum Hcy concentrations were analyzed by fluorescence polarization immunoassay using the IMx Homocysteine Reagent Pack and IMx Analyzer (Abbott Laboratories).
Measured: Change of serum homocysteine levels from the beginning of anesthesia to the end.Serum homocysteine levels were measured at admission, after 1 hours,after 2 hours,after 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start7 Nov 2018
- Primary completion31 Mar 2019 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthetic ToxicityStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Jiang, MD,PhD, Principal investigator, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746340
- Sponsor's protocol ID
- SH9H-2018-T53-2
- Status last verified
- Nov 2018
- First submitted
- 8 Nov 2018
- Last updated
- 19 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different General Anesthetics on Serum Folic Acid and Homocysteine Concentrations in Children
- ClinicalTrials.gov ID
- NCT03746340
- Acronym / sponsor ID
- SH9H-2018-T53-2
- Conditions
- Anesthetic Toxicity
- Keywords
- sevoflurane, propofol, Folic Acid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 19 Nov 2018 (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 concentration of folic acid and homocysteine in the blood can be used as independent risk factors for a variety of diseases. A sustained decrease in blood folate concentration and an increase in homocysteine concentration can damage vascular endothelial cells, causing varying degrees of neurodevelopmental abnormalities. Many clinical studies have found that anesthetics can affect blood folate and homocysteine concentration, but the effects of sevoflurane and propofol on blood folate and homocysteine concentrations are not clear. Therefore, this study aims to investigate the effects of sevoflurane and propofol on blood folate and homocysteine levels in children.
Detailed description
Retrospective study: Study the medical history of infants and young children (less than 3 years old) who underwent sevoflurane or propofol general anesthesia for more than 3 hours from January 2018 to December 2018, and compare the preoperative and postoperative serum folate changes for retrospective analysis.
Prospective study：Ten infants and young children (less than 3 years old) who underwent general anesthesia from November 7, 2018 to December 31, 2018 in Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. Inhalation of 1-8% concentration of sevoflurane for general anesthesia induced intubation, followed by sevoflurane 2.0 ~ 2.5 Vol% inhalation maintenance, according to the intraoperative situation to add opioids. Patients maintained a bispectral index (BIS) monitoring between 50 and 60. After induction of general anesthesia in all patients, Serum folate levels were measured before the start of surgery, every 1 hour during surgery, and at the end of surgery.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anesthetic | – | Drug: Propofol, Drug: SevofluraneSevoflurane Group Propofol Group |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under 3 years old who underwent general anesthesia
Key inclusion criteria (4 listed)
- Children under 3 years old who underwent general anesthesia
- Those who did not participate in other clinical trials within 3 months
- No acute infectious diseases, systemic diseases
- The family member of the child agrees to the test and signs the informed consent form.
Key exclusion criteria (5 listed)
- Refusal to join the group
- severe liver and kidney damage
- Hemodynamic instability (shock, blood pressure drop > 30% of basal blood pressure)
- Children with egg and milk allergy
- Children with a family history of malignant hyperthermia
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 |
|---|---|---|
| PropofolPropofol group: intravenous Propofol (2.0mg / kg) for general anesthesia induction, maintained for 30~60s. Continuous intravenous infusion of Propofol (7~8 mg·kg-1·h-1) with a syringe pump maintains a smooth general anesthetic sedative effect. | Drug | Anesthetic |
| SevofluraneSevoflurane group: Inhalation of 1-8% sevoflurane for induction.Then Inhalation of sevoflurane (2.0~2.5Vol%) was maintained | Drug | Anesthetic |
Primary outcome
levels of folate in the perioperative serum
Time frame: Change of serum folate levels from the beginning of anesthesia to the end.Serum folate levels were measured at admission, after 1 hours,after 2 hours,after 3 hours.
a Chemiluminescent Microparticle Folate Binding Protein assay with the ARCHITECT Folate Reagent Kit (Abbott Laboratories, IL, USA) was used to determine serum folate concentrations. Serum folate concentrations were quantified using the ARCHITECT i2000 SR System (Abbott Laboratories).
levels of homocysteine in the perioperative serum
Time frame: Change of serum homocysteine levels from the beginning of anesthesia to the end.Serum homocysteine levels were measured at admission, after 1 hours,after 2 hours,after 3 hours.
Serum Hcy concentrations were analyzed by fluorescence polarization immunoassay using the IMx Homocysteine Reagent Pack and IMx Analyzer (Abbott Laboratories).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
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Education, Questionnaires
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.
Hong Jiang, MD,PhD principal investigator
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
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 Anesthetic Toxicity, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 4 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: status not confirmed, as of the sponsor's last update on 19 Nov 2018. 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?
Results are not available in the source record.
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 folate in the perioperative serum (time frame: Change of serum folate levels from the beginning of anesthesia to the end.Serum folate levels were measured at admission, after 1 hours,after 2 hours,after 3 hours.). 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?
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 Nov 2018.