Vasodilation Effect of Inhalational Anesthetics - Full Text View

Sponsored by:	Nanjing Medical University
Information provided by:	Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT00815269

Purpose

Previous studies on animal 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.

Condition	Intervention
General Anesthesia	Drug: Halothane Drug: Isoflurane Drug: Sevoflurane Drug: Desflurane Drug: Enflurane

MedlinePlus related topics: Anesthesia Ultrasound

Drug Information available for: Sevoflurane Isoflurane I 653 Enflurane Halothane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Vasodilation Effect of Inhalational Anesthetics Including Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:

Ultrasonography of blood vessels including radial artery, brachial artery, femoral artery, popliteal artery [ Time Frame: 10min prior to anesthesia; immediate time of anesthesia; immediate time of the end of anesthesia induction; 5, 10, 20, 30, 60min during maintenance of the anesthesia ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Blood flow volume during anesthesia of the vasculature [ Time Frame: 10min prior to anesthesia; immediate time of anesthesia; immediate time of the end of anesthesia induction; 5, 10, 20, 30, 60min during maintenance of the anesthesia ] [ Designated as safety issue: Yes ]
Blood pressure including systolic, diastolic and mean artery blood pressures [ Time Frame: 10min prior to anesthesia; immediate time of anesthesia; immediate time of the end of anesthesia induction; 5, 10, 20, 30, 60min during maintenance of the anesthesia ] [ Designated as safety issue: Yes ]
The time interval of between the initiation of the inhalational anesthetics delivered to the beginning of decreasing of blood pressure [ Time Frame: From the delivery of anesthetic till the first time of blood pressure decreased ] [ Designated as safety issue: Yes ]
The total dose of phenylephrine required to maintain baseline arterial blood pressure [ Time Frame: From the delivery of anesthetic to 20min after anesthesia begun ] [ Designated as safety issue: Yes ]
Regression and correlation analyses between different doses of the anesthetics and the extent of vasodilation [ Time Frame: At the end of the anesthesia ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	December 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Halothane anesthesia: induction and maintenance with different doses	Drug: Halothane Induction: 2-4% halothane pluses 3-5 L/min oxygen Maintenance: different doses from 0.5% to 3% with 1-2 L/min oxygen
2: Experimental Isoflurane anesthesia: induction and maintenance with different doses	Drug: Isoflurane Induction: 2-5% isoflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
3: Experimental Sevoflurane anesthesia: induction and maintenance with different doses	Drug: Sevoflurane Induction: 3-8% sevoflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
4: Experimental Desflurane anesthesia: induction and maintenance with different doses	Drug: Desflurane Induction: 2-8% desflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
5: Experimental Enflurane anesthesia: induction and maintenance with different doses	Drug: Enflurane Induction: 2-5% enflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen

Eligibility

Ages Eligible for Study:	19 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must be undergo 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815269

Contacts

Contact: FuZhou Wang, MD	86-25-84460777 ext 3301	zfwang50@gmail.com
Contact: ShiQin Xu, MD	86-25-84460777 ext 3301	xusqnj@sina.com

Locations

China, Jiangsu
Nanjing Maternal and Child Health Care Hospital	Recruiting
Nanjing, Jiangsu, China, 210004
Contact: YuZhu Peng, MD 86-25-8446-0777 ext 1508 pyz1131@hotmail.com
Contact: XiRong Guo, MD 86-25-8446-0777 ext 1508 xrguonjmueducn@yahoo.com.cn
Sub-Investigator: YuSheng Liu, MD

Sponsors and Collaborators

Nanjing Medical University

Investigators

Study Director:

XiaoFeng Shen, MD

Nanjing Medical University

More Information

Responsible Party:	Nanjing Medical University ( XiaoFeng Shen )
Study ID Numbers:	NMU-200812-MZ39, NJFY0812015
Study First Received:	December 26, 2008
Last Updated:	December 26, 2008
ClinicalTrials.gov Identifier:	NCT00815269
Health Authority:	China: Ethics Committee

Keywords provided by Nanjing Medical University:

Inhalant anesthetic
Vasodilation
General anesthesia
Ultrasonography

Study placed in the following topic categories:

Enflurane
Desflurane
Halothane
Isoflurane
Sevoflurane

Additional relevant MeSH terms:

Anesthetics, Inhalation
Anesthetics, General
Therapeutic Uses
Hematologic Agents
Physiological Effects of Drugs

Central Nervous System Depressants
Anesthetics
Platelet Aggregation Inhibitors
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009