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Comparison of Analgesic Effect of Volatile Anesthetics

Sponsor
Kangbuk Samsung Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02830243
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
2.9
Actual Duration (Months)
31.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this clinical trial is to compare analgesic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using surgical pleth index.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Volatile anesthetics vary in their relative hypnotic potency. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetic agents may produce different bispectral index values. However, the difference between analgesic effects of volatile anesthetics have not yet been investigated. The purpose of this clinical trial is to compare analgesic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using surgical pleth index-guided remifentanil infusion.

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Comparison of Analgesic Effect of Volatile Anesthetics Using Surgical Pleth Index
Actual Study Start Date :
Jul 12, 2016
Actual Primary Completion Date :
Oct 5, 2016
Actual Study Completion Date :
Oct 8, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sevoflurane

Anesthesia was maintained with sevoflurane.

Drug: Sevoflurane
End-tidal concentration of sevoflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period. The remifentanil infusion rate was adjusted using TCI pump to achieve surgical pleth index between 20 and 50.
Other Names:
  • SEVO

    		•
    Experimental: Desflurane

    Anesthesia was maintained with desflurane.

    Drug: Desflurane
    End-tidal concentration of desflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period. The remifentanil infusion rate was adjusted using TCI pump to achieve surgical pleth index between 20 and 50.
    Other Names:
  • DES

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Remifentanil consumption (µg/kg/min) [During the intraoperative period]

    Secondary Outcome Measures

    1. Target effective site concentration of remifentanil (ng/ml) [After at least 10 min of stable surgical pleth index values]

    Eligibility Criteria

    Criteria

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

    • patients undergoing balanced general anesthesia using volatile anesthetics and remifentanil

    • patients with american society of anesthesiologist physical status I, II

    • patients aged 19-65 years

    • patients obtaining written informed consent

    Exclusion Criteria:

    • patients with a history of any psychiatric or neurological disease

    • patients who had received any medication affecting the central nervous system

    • patients who had received medication affecting the sympathetic or parasympathetic nervous systems

    • patients undergoing tracheal intubation for airway management

    • 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: Kyoungho Ryu, M.D., Kangbuk Samsung Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kyoungho Ryu, Clinical assistant professor, Kangbuk Samsung Hospital
    ClinicalTrials.gov Identifier:
    NCT02830243
    Other Study ID Numbers:
    • 2016-05-058
    First Posted:
    Jul 12, 2016
    Last Update Posted:
    May 15, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Sevoflurane
    Desflurane

    Study Results

    No Results Posted as of May 15, 2018