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Hemodynamics for Equi-MAC Anesthesia

Sponsor
Kangbuk Samsung Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03570164
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
4.9
Actual Duration (Months)
14.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to compare the peripheral perfusion index values produced by equi-MAC of sevoflurane and desflurane in patients undergoing single-agent inhalation anesthesia.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Ether derivative anesthetics, including sevoflurane and desflurane, have direct activity on vascular tissue and both are vasodilators. However, there has been no direct comparison of vasodilative effect between sevoflurane and desflurane in vivo in humans. Peripheral perfusion index derived from photoplethysmographic waveform reflects peripheral vasomotor tone. Therefore, the purpose of this study is to compare the peripheral perfusion index values produced by sevoflurane and desflurane at equipotent concentration in patients undergoing single-agent inhalation anesthesia.

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Comparison of Vasodilative Effects Between Sevoflurane and Desflurane Using Peripheral Perfusion Index
Actual Study Start Date :
Jun 18, 2018
Actual Primary Completion Date :
Nov 13, 2018
Actual Study Completion Date :
Nov 13, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sevoflurane

Anesthesia is maintained with sevoflurane.

Drug: Sevoflurane
End-tidal concentration of sevoflurane is maintained at age-corrected 1.0 minimum alveolar concentration throughout the study period.
Other Names:
  • Sevorane

    		•
    Experimental: Desflurane

    Anesthesia is maintained with desflurane.

    Drug: Desflurane
    End-tidal concentration of desflurane is maintained at age-corrected 1.0 minimum alveolar concentration throughout the study period.
    Other Names:
  • Suprane

    		•

    Outcome Measures

    Primary Outcome Measures

    1. peripheral perfusion index [After a 30-min waiting period from the induction of anesthesia]

      peripheral perfusion index value at a steady-state anesthesia of age-corrected 1.0 MAC

    Secondary Outcome Measures

    1. mean arterial pressure [After a 30-min waiting period from the induction of anesthesia]

      mean arterial pressure at a steady-state anesthesia of age-corrected 1.0 MAC

    2. heart rate [After a 30-min waiting period from the induction of anesthesia]

      heart rate at a steady-state anesthesia of age-corrected 1.0 MAC

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patients aged between 19 and 65 yr

    • patients with American Society of Anesthesiologists physical status classification I or II

    • patients scheduled for elective arthroscopic knee surgery under general anesthesia

    • patients obtaining written informed consent

    Exclusion Criteria:

    • patients with a history of any disease associated with the autonomic nervous system

    • patients receiving any medication affecting the sympathetic or parasympathetic nervous systems

    • patients with cardiac arrhythmia, diabetes mellitus, and alcohol or drug abuse

    • pregnant women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kangbuk Samsung Hospital Seoul Korea, Republic of 03181

    Sponsors and Collaborators

    • Kangbuk Samsung Hospital

    Investigators

    • Principal Investigator: Kyoung-Ho Ryu, M.D., Kangbuk Samsung Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kyoung-Ho Ryu, MD, Assistant professor, Kangbuk Samsung Hospital
    ClinicalTrials.gov Identifier:
    NCT03570164
    Other Study ID Numbers:
    • 2018-05-019
    First Posted:
    Jun 26, 2018
    Last Update Posted:
    Oct 21, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sevoflurane
    Desflurane

    Study Results

    No Results Posted as of Oct 21, 2019