- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00815269
Vasodilation Effect of Inhalational Anesthetics (VEFIHA)
December 22, 2009 updated by: Nanjing Medical University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Jiangsu
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Nanjing, Jiangsu, China, 210004
- Nanjing Maternal and Child Health Care Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must be undergoing general anesthesia
- Age between 19-45 years
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Halothane anesthesia: induction and maintenance with different doses
|
Induction: 2-4% halothane pluses 3-5 L/min oxygen Maintenance: different doses from 0.5% to 3% with 1-2 L/min oxygen
Other Names:
|
Experimental: 2
Isoflurane anesthesia: induction and maintenance with different doses
|
Induction: 2-5% isoflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
Other Names:
|
Experimental: 3
Sevoflurane anesthesia: induction and maintenance with different doses
|
Induction: 3-8% sevoflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
Other Names:
|
Experimental: 4
Desflurane anesthesia: induction and maintenance with different doses
|
Induction: 2-8% desflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
Other Names:
|
Experimental: 5
Enflurane anesthesia: induction and maintenance with different doses
|
Induction: 2-5% enflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
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From the beginning of anesthesia (0 min) to 20 min after anesthesia begun
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Regression and correlation analyses between different doses of the anesthetics and the extent of vasodilation
Time Frame: Forty eight hours after operation
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Forty eight hours after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
December 26, 2008
First Submitted That Met QC Criteria
December 26, 2008
First Posted (Estimate)
December 29, 2008
Study Record Updates
Last Update Posted (Estimate)
December 23, 2009
Last Update Submitted That Met QC Criteria
December 22, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMU-200812-MZ39
- NJFY0812015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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