The Effects of General Anesthesia on Microcirculation of Central and Peripheral Soft Tissue: a Comparison of Inhalational and Intravenous Anesthetics

NCT ID: NCT02530632

Last Updated: 2016-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-09-30

Brief Summary

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Effects of different general anesthetics on peripheral microcirculation.

Detailed Description

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Human keep body temperature in a narrow range by a variety of regulatory mechanism. Peripheral thermal receptors send signals to central nervous system which regulate body temperature via peripheral effectors, such as vasoconstriction, vasodilatation, shivering, sweating and etc. In patients undergoing general anesthesia, the regulatory mechanism is altered. General anesthesia changes blood distribution in the body, the metabolic rate of muscle, threshold of thermal regulation in the brain and etc, so that heat distribution and microcirculation condition will also change. In this study, near-infrared spectroscopy (NIRS) is used to measure the microcirculatory condition. NIRS is a non-invasive continuous measurement to detect tissue saturation with the method of different wavelength of near-infrared. General anesthesia with inhalational sevoflurane and intravenous propofol is separated into 2 groups. Because of different mechanism of general anesthesia of these 2 anesthetics, different physiologic response may occur. Body temperature and somatic saturation are compared in each group.

Conditions

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Microcirculatory Effects of Anesthesia Inhalation and Intravenous Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Sevoflurane anesthesia

Anesthesia maintained with inhalational sevoflurane

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

General anesthesia maintained with inhalational sevoflurane

General anesthesia induction

Intervention Type PROCEDURE

Induce routine of general anesthesia, including propofol 1-3mg/kg, fentanyl 1-3mcg/kg, cisatracurium 0.2-0.3mg/kg.

Propofol anesthesia

Anesthesia maintained with intravenous propofol continuous infusion

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

General anesthesia maintained with intravenous propofol infusion

General anesthesia induction

Intervention Type PROCEDURE

Induce routine of general anesthesia, including propofol 1-3mg/kg, fentanyl 1-3mcg/kg, cisatracurium 0.2-0.3mg/kg.

Interventions

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Propofol

General anesthesia maintained with intravenous propofol infusion

Intervention Type DRUG

Sevoflurane

General anesthesia maintained with inhalational sevoflurane

Intervention Type DRUG

General anesthesia induction

Induce routine of general anesthesia, including propofol 1-3mg/kg, fentanyl 1-3mcg/kg, cisatracurium 0.2-0.3mg/kg.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Breast surgeries under general anesthesia
2. BMI 18.5\~30

Exclusion Criteria

1. Cardiac disease
2. Lung disease
3. Renal disease
4. Neurological disease
5. Autonomic nervous system dysfunction
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shou-Zen Fan

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Cheng-Han Yen

Role: CONTACT

+886972653387

Cheng-Han Yen

Role: CONTACT

+886972653387

Facility Contacts

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Shou-Zen Fan

Role: primary

886-23123456 ext. 65523

Other Identifiers

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201504089RIND

Identifier Type: -

Identifier Source: org_study_id

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