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

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

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

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:
  • Fluothane
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:
  • Forane
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:
  • Sevorane
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:
  • Suprane
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:
  • Ethrane

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
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
Forty eight hours after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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