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The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics

Sponsor
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine (Other)
Overall Status
Suspended
CT.gov ID
NCT03588429
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
8.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this clinical trial is to evaluate the ratio of hypnotic to analgesic potency of sevoflurane and isoflurane at equi-minimum alveolar concentration using EEG analysis.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Anesthetic agents vary in their relative hypnotic potency. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetic agents may produce different spectral entropy or bispectral index values. However, there is no study that demonstrate the difference between analgesic potency of volatile anesthetics. The aim of this clinical trial is to evaluate the ratio of hypnotic to analgesic potency of sevoflurane and isoflurane at equi-minimum alveolar concentration using EEG analysis.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics
Anticipated Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Aug 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sevoflurane

Anesthesia was maintained with sevoflurane.

Drug: Sevoflurane
Anesthesia was maintained with sevoflurane in patients undergoing standardized nociceptive stimulus (long-lasting tetanic stimulus of the ulnar nerve; 30 s, 50 mA, 50 Hz, square-wave).
Other Names:
  • SEVO

    		•
    Experimental: Isoflurane

    Anesthesia was maintained with isoflurane.

    Drug: Isoflurane
    Anesthesia was maintained with isoflurane in patients undergoing standardized nociceptive stimulus (long-lasting tetanic stimulus of the ulnar nerve; 30 s, 50 mA, 50 Hz, square-wave).
    Other Names:
  • ISO

    		•

    Outcome Measures

    Primary Outcome Measures

    1. qCON index [the 10 min at steady-state anesthesia after endotracheal intubation]

      The hypnotic potency of volatile anesthetics was evaluated by qCON index during standardized nociceptive stimulus (30 s, 50 mA, 50 Hz tetanic stimulation).

    Secondary Outcome Measures

    1. qNOX index [the 10 min at steady-state anesthesia after endotracheal intubation]

      The analgesic potency of volatile anesthetics was evaluated by qNOX index during standardized nociceptive stimulus (30 s, 50 mA, 50 Hz tetanic stimulation).

    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 general anesthesia using volatile anesthetics and intubation

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

    • 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 supraglottic airway for airway management

    • pregnant women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine Cangzhou Hebei China 061001

    Sponsors and Collaborators

    • Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

    Investigators

    • Principal Investigator: Ruizhao Lv, M.D, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
    ClinicalTrials.gov Identifier:
    NCT03588429
    Other Study ID Numbers:
    • 2018CZTCWM
    First Posted:
    Jul 17, 2018
    Last Update Posted:
    Apr 25, 2019
    Last Verified:
    Aug 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
    Sevoflurane
    Isoflurane
    Additional relevant MeSH terms:
    Sevoflurane
    Isoflurane

    Study Results

    No Results Posted as of Apr 25, 2019