Vasodilation Effect of Inhalational Anesthetics - Full Text View

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

Purpose

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.

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

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

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Ultrasound

Drug Information available for: Enflurane Isoflurane Sevoflurane I 653 Halothane

U.S. FDA Resources

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: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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 ] [ 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 beginning of anesthesia (0 min) till the first time of blood pressure decreased, this measure would be varied according to different individuals ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Regression and correlation analyses between different doses of the anesthetics and the extent of vasodilation [ Time Frame: Forty eight hours after operation ] [ Designated as safety issue: No ]

Enrollment:	300
Study Start Date:	December 2008
Study Completion Date:	December 2009
Primary Completion Date:	December 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 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

Contacts and Locations

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

Locations

China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004

Sponsors and Collaborators

Nanjing Medical University

Investigators

Study Director:

XiaoFeng Shen, MD

Nanjing Medical University

More Information

No publications provided

Responsible Party:	Nanjing Medical University ( XiaoFeng Shen )
Study ID Numbers:	NMU-200812-MZ39, NJFY0812015
Study First Received:	December 26, 2008
Last Updated:	December 22, 2009
ClinicalTrials.gov Identifier:	NCT00815269 History of Changes
Health Authority:	China: Ethics Committee

Keywords provided by Nanjing Medical University:

Inhalant anesthetic
Vasodilation
General anesthesia
Ultrasonography

Additional relevant MeSH terms:

Hematologic Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pharmacologic Actions
Sevoflurane
Enflurane
Desflurane

Anesthetics, Inhalation
Anesthetics, General
Therapeutic Uses
Halothane
Isoflurane
Platelet Aggregation Inhibitors
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010