VEFIHA: Vasodilation Effect of Inhalational Anesthetics

Sponsor

Nanjing Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT00815269

Collaborator

(none)

300

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
General Anesthesia	Drug: Halothane Drug: Isoflurane Drug: Sevoflurane Drug: Desflurane Drug: Enflurane	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Vasodilation Effect of Inhalational Anesthetics Including Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: 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 Names: 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 Names: Ethrane

Outcome Measures

Primary Outcome Measures

Ultrasonography of blood vessels including radial artery, brachial artery, femoral artery, popliteal artery [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

Blood flow volume during anesthesia of the vasculature [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 [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 [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 [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 [Forty eight hours after operation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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