Vasodilation Effect of Inhalational Anesthetics

General Anesthesia Clinical Trial

— VEFIHA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00815269
• Other study ID #: NMU-200812-MZ39
• Secondary ID: NJFY0812015
• Status: Completed
• Phase: N/A
• First received: December 26, 2008
• Last updated: December 22, 2009
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• General Anesthesia

Intervention

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
• Isoflurane
Induction: 2-5% isoflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
• Sevoflurane
Induction: 3-8% sevoflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
• Desflurane
Induction: 2-8% desflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
• Enflurane
Induction: 2-5% enflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Regression and correlation analyses between different doses of the anesthetics and the extent of vasodilation		Forty eight hours after operation	No