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Vasodilation Effect of Inhalational Anesthetics (VEFIHA)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00815269
First received: December 26, 2008
Last updated: December 22, 2009
Last verified: December 2009
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vasodilation Effect of Inhalational Anesthetics Including Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane

Resource links provided by NLM:

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
Active Comparator: 1
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
Other Name: Fluothane
Experimental: 2
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
Other Name: Forane
Experimental: 3
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
Other Name: Sevorane
Experimental: 4
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
Other Name: Suprane
Experimental: 5
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
Other Name: Ethrane

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

Keywords provided by Nanjing Medical University:
Inhalant anesthetic
Vasodilation
General anesthesia
Ultrasonography

Additional relevant MeSH terms:
Anesthetics
Enflurane
Halothane
Isoflurane
Desflurane
Sevoflurane
Anesthetics, Inhalation
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, General
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on May 23, 2013