Microcirculatory Effects of AnesthesiaNCT02530632
The Effects of General Anesthesia on Microcirculation of Central and Peripheral Soft Tissue: a Comparison of Inhalational and Intravenous Anesthetics
A study testing Propofol, Sevoflurane and General anesthesia induction in people with Microcirculatory Effects of Anesthesia and Inhalation and Intravenous Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Effects of different general anesthetics on peripheral microcirculation. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Microcirculatory Effects of Anesthesia, Inhalation and Intravenous Anesthesia
- What is being tested?
- Propofol, Sevoflurane and General anesthesia induction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2015to Sep 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast surgeries under general anesthesia
- BMI 18.5~30
Who cannot join
- Cardiac disease
- Lung disease
- Renal disease
- Neurological disease
- Autonomic nervous system dysfunction
Trial locations and contacts
1 site in 1 country.
Cheng-Han Yen contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Shou-Zen Fan, 886-23123456 ext. 65523, shouzen@gmail.com
About this study
Effects of different general anesthetics on peripheral microcirculation.
Read the detailed description
Human keep body temperature in a narrow range by a variety of regulatory mechanism. Peripheral thermal receptors send signals to central nervous system which regulate body temperature via peripheral effectors, such as vasoconstriction, vasodilatation, shivering, sweating and etc. In patients undergoing general anesthesia, the regulatory mechanism is altered. General anesthesia changes blood distribution in the body, the metabolic rate of muscle, threshold of thermal regulation in the brain and etc, so that heat distribution and microcirculation condition will also change. In this study, near-infrared spectroscopy (NIRS) is used to measure the microcirculatory condition. NIRS is a non-invasive continuous measurement to detect tissue saturation with the method of different wavelength of near-infrared. General anesthesia with inhalational sevoflurane and intravenous propofol is separated into 2 groups. Because of different mechanism of general anesthesia of these 2 anesthetics, different physiologic response may occur. Body temperature and somatic saturation are compared in each group.
- Being tested
- Propofol, Sevoflurane, General anesthesia induction
- Keywords
- microperfusion, temperature, near-infrared spectroscopy, anesthesia, total intravenous anaesthesia
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
General anesthesia maintained with intravenous propofol infusion
SevofluraneDrug
General anesthesia maintained with inhalational sevoflurane
General anesthesia inductionProcedure or surgery
Induce routine of general anesthesia, including propofol 1-3mg/kg, fentanyl 1-3mcg/kg, cisatracurium 0.2-0.3mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane anesthesia | Active comparator | Anesthesia maintained with inhalational sevoflurane Receives: Drug: Sevoflurane; Procedure: General anesthesia induction |
| Propofol anesthesia | Experimental | Anesthesia maintained with intravenous propofol continuous infusion Receives: Drug: Propofol; Procedure: General anesthesia induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Somatic saturation
Change of somatic saturation measured by NIRS
Measured: during surgery, approximately 2-4 hr
Secondary outcomes (1)
Body temperature
Nasal and peripheral temperature
Measured: during surgery, approximately 2-4 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microcirculatory Effects of AnesthesiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shou-Zen Fan, Principal investigator, Department of Anesthesiology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530632
- Sponsor's protocol ID
- 201504089RIND
- Status last verified
- Apr 2016
- First submitted
- 17 Aug 2015
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of General Anesthesia on Microcirculation of Central and Peripheral Soft Tissue: a Comparison of Inhalational and Intravenous Anesthetics
- ClinicalTrials.gov ID
- NCT02530632
- Acronym / sponsor ID
- 201504089RIND
- Keywords
- microperfusion, temperature, near-infrared spectroscopy, anesthesia, total intravenous anaesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 21 Aug 2015 (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.
Effects of different general anesthetics on peripheral microcirculation.
Detailed description
Human keep body temperature in a narrow range by a variety of regulatory mechanism. Peripheral thermal receptors send signals to central nervous system which regulate body temperature via peripheral effectors, such as vasoconstriction, vasodilatation, shivering, sweating and etc. In patients undergoing general anesthesia, the regulatory mechanism is altered. General anesthesia changes blood distribution in the body, the metabolic rate of muscle, threshold of thermal regulation in the brain and etc, so that heat distribution and microcirculation condition will also change. In this study, near-infrared spectroscopy (NIRS) is used to measure the microcirculatory condition. NIRS is a non-invasive continuous measurement to detect tissue saturation with the method of different wavelength of near-infrared. General anesthesia with inhalational sevoflurane and intravenous propofol is separated into 2 groups. Because of different mechanism of general anesthesia of these 2 anesthetics, different physiologic response may occur. Body temperature and somatic saturation are compared in each group.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane anesthesia | Active comparator | Drug: Sevoflurane, Procedure: General anesthesia inductionAnesthesia maintained with inhalational sevoflurane |
| Propofol anesthesia | Experimental | Drug: Propofol, Procedure: General anesthesia inductionAnesthesia maintained with intravenous propofol continuous infusion |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Breast surgeries under general anesthesia
- BMI 18.5~30
Key exclusion criteria (5 listed)
- Cardiac disease
- Lung disease
- Renal disease
- Neurological disease
- Autonomic nervous system dysfunction
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 |
|---|---|---|
| PropofolGeneral anesthesia maintained with intravenous propofol infusion | Drug | Propofol anesthesia |
| SevofluraneGeneral anesthesia maintained with inhalational sevoflurane | Drug | Sevoflurane anesthesia |
| General anesthesia inductionInduce routine of general anesthesia, including propofol 1-3mg/kg, fentanyl 1-3mcg/kg, cisatracurium 0.2-0.3mg/kg. | Procedure or surgery | Propofol anesthesia, Sevoflurane anesthesia |
Primary outcome
Somatic saturation
Time frame: during surgery, approximately 2-4 hr
Change of somatic saturation measured by NIRS
1 secondary outcome
Body temperature
Time frame: during surgery, approximately 2-4 hr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
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.
Cheng-Han Yen contact
Shou-Zen Fan principal investigator
Department of Anesthesiology, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol, Sevoflurane and General anesthesia induction in people with Microcirculatory Effects of Anesthesia and Inhalation and Intravenous Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 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 13 Apr 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 Taiwan. 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?
Contact Cheng-Han Yen (+886972653387, ozone0924@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Somatic saturation (time frame: during surgery, approximately 2-4 hr). 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 13 Apr 2016.