The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics

Sponsor
Kangbuk Samsung Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02698514
Collaborator
(none)
90
1
2
4.9
18.5

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 desflurane at equi-minimum alveolar concentration using SPI and 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 desflurane at equi-minimum alveolar concentration using SPI and EEG analysis.

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 Ratio of Hypnotic to Analgesic Potency of Sevoflurane and Desflurane : Randomized Controlled Trial
Actual Study Start Date :
Feb 16, 2016
Actual Primary Completion Date :
Jul 13, 2016
Actual Study Completion Date :
Jul 13, 2016

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: Desflurane

    Anesthesia was maintained with desflurane.

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

    Primary Outcome Measures

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

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

    Secondary Outcome Measures

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

      The hypnotic potency of volatile anesthetics was evaluated by bispectral 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 supraglottic airway (I-gelâ„¢)

    • 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:
    NCT02698514
    Other Study ID Numbers:
    • 2015-12-023
    First Posted:
    Mar 3, 2016
    Last Update Posted:
    May 8, 2018
    Last Verified:
    May 1, 2018
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 8, 2018