Vasodilation Effect of Inhalational Anesthetics (VEFIHA)

• ClinicalTrials.gov Identifier: NCT00815269
• Recruitment Status: Completed
• First Posted: December 29, 2008
• Last Update Posted: December 23, 2009
• Sponsor: Nanjing Medical University
• Information provided by: Nanjing Medical University

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: December 2008
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: December 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 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

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. 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 ]
4. 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 ]
5. Regression and correlation analyses between different doses of the anesthetics and the extent of vasodilation [ Time Frame: Forty eight hours after operation ]

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: XiaoFeng Shen, Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT00815269
• Other Study ID Numbers: NMU-200812-MZ39; NJFY0812015
• First Posted: December 29, 2008
• Last Update Posted: December 23, 2009
• Last Verified: December 2009

Keywords provided by Nanjing Medical University:

Inhalant anesthetic; Vasodilation; General anesthesia; Ultrasonography

Additional relevant MeSH terms:

Sevoflurane; Desflurane; Isoflurane; Halothane; Enflurane; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs