General AnesthesiaVEFIHANCT00815269
Vasodilation Effect of Inhalational Anesthetics
A study testing Halothane, Isoflurane and Sevoflurane in people with General Anesthesia, run by Nanjing Medical University at 1 site in China.
Trial summary
Previous studies on animals suggest that inhalational anesthetics can reduce vascular tension in vitro resulting in vasodilation and decrease in blood pressure. This role for inhalational anesthetics has essential clinical implications such as the condition of sepsis or septic shock or other shock-associated states… Read more about this study
- Who is it for?
- Ages 19 to 45 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Halothane, Isoflurane and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Dec 2008to Dec 2009
- 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 19 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must be undergoing general anesthesia
- Age between 19-45 years
Who cannot join
- With hypertension
- Existing organic dysfunction
- Allergic to inhalant anesthetics
- Alcohol addictive or narcotic dependent patients
- A history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: Vasodilation Effect of Inhalational Anesthetics Including Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane
Previous studies on animals suggest that inhalational anesthetics can reduce vascular tension in vitro resulting in vasodilation and decrease in blood pressure. This role for inhalational anesthetics has essential clinical implications such as the condition of sepsis or septic shock or other shock-associated states during which the blood vessel constricts strongly and leads to circulation dysfunction. The vasodilation property of these anesthetics including halothane, isoflurane, sevoflurane, desflurane and enflurane enables them to be better options than other general anesthetics in many clinical conditions needing the vasculature to be dilated. The investigators hypothesized that these inhalational anesthetics can evoke vasodilation measured with ultrasonography during general anesthesia in vivo as the in vitro studies displayed.
- Conditions
- General Anesthesia
- Being tested
- Halothane, Isoflurane, Sevoflurane, Desflurane, Enflurane
- Keywords
- Inhalant anesthetic, Vasodilation, General anesthesia, Ultrasonography
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HalothaneDrug
Also called Fluothane
Induction: 2-4% halothane pluses 3-5 L/min oxygen Maintenance: different doses from 0.5% to 3% with 1-2 L/min oxygen
IsofluraneDrug
Also called Forane
Induction: 2-5% isoflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
SevofluraneDrug
Also called Sevorane
Induction: 3-8% sevoflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
DesfluraneDrug
Also called Suprane
Induction: 2-8% desflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
EnfluraneDrug
Also called Ethrane
Induction: 2-5% enflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Halothane anesthesia: induction and maintenance with different doses Receives: Drug: Halothane |
| 2 | Experimental | Isoflurane anesthesia: induction and maintenance with different doses Receives: Drug: Isoflurane |
| 3 | Experimental | Sevoflurane anesthesia: induction and maintenance with different doses Receives: Drug: Sevoflurane |
| 4 | Experimental | Desflurane anesthesia: induction and maintenance with different doses Receives: Drug: Desflurane |
| 5 | Experimental | Enflurane anesthesia: induction and maintenance with different doses Receives: Drug: Enflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography of blood vessels including radial artery, brachial artery, femoral artery, popliteal artery
Measured: Ten min prior to anesthesia; 0 min of anesthesia; 0 min of the end of anesthesia induction; 5, 10, 20, 30, 60 min during maintenance of the anesthesia
Secondary outcomes (5)
Blood flow volume during anesthesia of the vasculature
Measured: Ten min prior to anesthesia; 0 min of anesthesia; 0 min of the end of anesthesia induction; 5, 10, 20, 30, 60 min during maintenance of the anesthesia
Blood pressure including systolic, diastolic and mean artery blood pressures
Measured: Ten min prior to anesthesia; 0 min of anesthesia; 0 min of the end of anesthesia induction; 5, 10, 20, 30, 60 min during maintenance of the anesthesia
The time interval of between the initiation of the inhalational anesthetics delivered to the beginning of decreasing of blood pressure
Measured: From the beginning of anesthesia (0 min) till the first time of blood pressure decreased, this measure would be varied according to different individuals
The total dose of phenylephrine required to maintain baseline arterial blood pressure
Measured: From the beginning of anesthesia (0 min) to 20 min after anesthesia begun
Regression and correlation analyses between different doses of the anesthetics and the extent of vasodilation
Measured: Forty eight hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Nanjing Medical 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoFeng Shen, MD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815269
- Sponsor's protocol ID
- NMU-200812-MZ39
- Other IDs
- NJFY0812015
- Acronym
- VEFIHA
- Status last verified
- Dec 2009
- First submitted
- 26 Dec 2008
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasodilation Effect of Inhalational Anesthetics Including Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane
- ClinicalTrials.gov ID
- NCT00815269
- Acronym / sponsor ID
- VEFIHA / NMU-200812-MZ39
- Conditions
- General Anesthesia
- Keywords
- Inhalant anesthetic, Vasodilation, General anesthesia, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Dec 2008 (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.
Previous studies on animals suggest that inhalational anesthetics can reduce vascular tension in vitro resulting in vasodilation and decrease in blood pressure. This role for inhalational anesthetics has essential clinical implications such as the condition of sepsis or septic shock or other shock-associated states during which the blood vessel constricts strongly and leads to circulation dysfunction. The vasodilation property of these anesthetics including halothane, isoflurane, sevoflurane, desflurane and enflurane enables them to be better options than other general anesthetics in many clinical conditions needing the vasculature to be dilated. The investigators hypothesized that these inhalational anesthetics can evoke vasodilation measured with ultrasonography during general anesthesia in vivo as the in vitro studies displayed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: HalothaneHalothane anesthesia: induction and maintenance with different doses |
| 2 | Experimental | Drug: IsofluraneIsoflurane anesthesia: induction and maintenance with different doses |
| 3 | Experimental | Drug: SevofluraneSevoflurane anesthesia: induction and maintenance with different doses |
| 4 | Experimental | Drug: DesfluraneDesflurane anesthesia: induction and maintenance with different doses |
| 5 | Experimental | Drug: EnfluraneEnflurane anesthesia: induction and maintenance with different doses |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Must be undergoing general anesthesia
- Age between 19-45 years
Key exclusion criteria (5 listed)
- With hypertension
- Existing organic dysfunction
- Allergic to inhalant anesthetics
- Alcohol addictive or narcotic dependent patients
- A history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
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 |
|---|---|---|
| HalothaneAlso: FluothaneInduction: 2-4% halothane pluses 3-5 L/min oxygen Maintenance: different doses from 0.5% to 3% with 1-2 L/min oxygen | Drug | 1 |
| IsofluraneAlso: ForaneInduction: 2-5% isoflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen | Drug | 2 |
| SevofluraneAlso: SevoraneInduction: 3-8% sevoflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen | Drug | 3 |
| DesfluraneAlso: SupraneInduction: 2-8% desflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen | Drug | 4 |
| EnfluraneAlso: EthraneInduction: 2-5% enflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen | Drug | 5 |
Primary outcome
Ultrasonography of blood vessels including radial artery, brachial artery, femoral artery, popliteal artery
Time frame: Ten min prior to anesthesia; 0 min of anesthesia; 0 min of the end of anesthesia induction; 5, 10, 20, 30, 60 min during maintenance of the anesthesia
5 secondary outcomes
Blood flow volume during anesthesia of the vasculature
Time frame: Ten min prior to anesthesia; 0 min of anesthesia; 0 min of the end of anesthesia induction; 5, 10, 20, 30, 60 min during maintenance of the anesthesia
Blood pressure including systolic, diastolic and mean artery blood pressures
Time frame: Ten min prior to anesthesia; 0 min of anesthesia; 0 min of the end of anesthesia induction; 5, 10, 20, 30, 60 min during maintenance of the anesthesia
The time interval of between the initiation of the inhalational anesthetics delivered to the beginning of decreasing of blood pressure
Time frame: From the beginning of anesthesia (0 min) till the first time of blood pressure decreased, this measure would be varied according to different individuals
The total dose of phenylephrine required to maintain baseline arterial blood pressure
Time frame: From the beginning of anesthesia (0 min) to 20 min after anesthesia begun
Regression and correlation analyses between different doses of the anesthetics and the extent of vasodilation
Time frame: Forty eight hours after operation
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 23 Dec 2009.
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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.
XiaoFeng Shen, MD study director
Nanjing Medical 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 Halothane, Isoflurane and Sevoflurane in people with General Anesthesia, run by Nanjing Medical 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 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: finished, as of the sponsor's last update on 23 Dec 2009. 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?
Ultrasonography of blood vessels including radial artery, brachial artery, femoral artery, popliteal artery (time frame: Ten min prior to anesthesia; 0 min of anesthesia; 0 min of the end of anesthesia induction; 5, 10, 20, 30, 60 min during maintenance of the anesthesia). 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 23 Dec 2009.