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Status unknownNCT02530632Updated Apr 13, 2016

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

An interventional study of Propofol and Sevoflurane in Microcirculatory Effects of Anesthesia and Inhalation and Intravenous Anesthesia, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-04-13.

Sponsored by National Taiwan University Hospital · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
Female
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Study summary

Effects of different general anesthetics on peripheral microcirculation.

Read the detailed description

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.

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Conditions studied

  • Microcirculatory Effects of Anesthesia
  • Inhalation and Intravenous Anesthesia

Keywords

  • microperfusion
  • temperature
  • near-infrared spectroscopy
  • anesthesia
  • total intravenous anaesthesia
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In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's planned enrollment of 100 is above the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Cardiac disease
  2. Lung disease
  3. Renal disease
  4. Neurological disease
  5. Autonomic nervous system dysfunction
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Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Sevoflurane anesthesia

    Anesthesia maintained with inhalational sevoflurane

    Drug: Sevoflurane · Procedure: General anesthesia induction

  • Experimental
    Propofol anesthesia

    Anesthesia maintained with intravenous propofol continuous infusion

    Drug: Propofol · Procedure: General anesthesia induction

Interventions

  • DrugPropofol

    General anesthesia maintained with intravenous propofol infusion

  • DrugSevoflurane

    General anesthesia maintained with inhalational sevoflurane

  • ProcedureGeneral anesthesia induction

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

06

What researchers measure

Primary outcomes

  1. Somatic saturation

    Change of somatic saturation measured by NIRS

    Time frame: during surgery, approximately 2-4 hr

Secondary outcomes

  1. Body temperature

    Nasal and peripheral temperature

    Time frame: during surgery, approximately 2-4 hr

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei City, 100, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02530632
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Aug 21, 2015
Start date
Aug 2015
Primary completion
Sep 2016 (estimated)
Completion
Sep 2016 (estimated)
Last update
Apr 13, 2016

Study contacts

Cheng-Han Yen
Contact
ozone0924@gmail.com
+886972653387
Cheng-Han Yen
Contact
+886972653387
Shou-Zen Fan
principal investigator · Department of Anesthesiology, National Taiwan University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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