Vasodilation Effect of Inhalational Anesthetics

NCT00815269 | Completed DMC

• 2 other identifiers: NMU-200812-MZ39NJFY0812015
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia

Keywords

Inhalant anesthetic; Vasodilation; General anesthesia; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (5)

1

ACTIVE COMPARATOR

Halothane anesthesia: induction and maintenance with different doses

Drug: Halothane

2

EXPERIMENTAL

Isoflurane anesthesia: induction and maintenance with different doses

Drug: Isoflurane

3

EXPERIMENTAL

Sevoflurane anesthesia: induction and maintenance with different doses

Drug: Sevoflurane

4

EXPERIMENTAL

Desflurane anesthesia: induction and maintenance with different doses

Drug: Desflurane

5

EXPERIMENTAL

Enflurane anesthesia: induction and maintenance with different doses

Drug: Enflurane

Interventions

Halothane DRUG

Induction: 2-4% halothane pluses 3-5 L/min oxygen Maintenance: different doses from 0.5% to 3% with 1-2 L/min oxygen

Also known as: Fluothane

1

Isoflurane DRUG

Induction: 2-5% isoflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen

Also known as: Forane

2

Sevoflurane DRUG

Induction: 3-8% sevoflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen

Also known as: Sevorane

3

Desflurane DRUG

Induction: 2-8% desflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen

Also known as: Suprane

4

Enflurane DRUG

Induction: 2-5% enflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen

Also known as: Ethrane

5

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must be undergoing general anesthesia
• Age between 19-45 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Conditions

Aneurysm

Interventions

Halothane; Isoflurane; Sevoflurane; Desflurane; Enflurane

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Ethyl Ethers

Study Officials

• XiaoFeng Shen, MD

  Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 26, 2008
• First Posted: December 29, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 23, 2009

Record last verified: 2009-12

Locations

CN (1)