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The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics

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ClinicalTrials.gov Identifier: NCT02698514
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Kyoungho Ryu, Kangbuk Samsung Hospital

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
Anesthesia, General Drug: Sevoflurane Drug: Desflurane 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.

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Study Type : Interventional  (Clinical Trial)
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 : February 16, 2016
Actual Primary Completion Date : July 13, 2016
Actual Study Completion Date : July 13, 2016

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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 Name: 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 Name: DES




Primary Outcome Measures :
  1. Surgical pleth index [ Time Frame: 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 [ Time Frame: 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).



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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing general anesthesia using volatile anesthetics and supraglottic airway (I-gel™)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698514


Locations
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Korea, Republic of
Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 03181
Sponsors and Collaborators
Kangbuk Samsung Hospital
Investigators
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Principal Investigator: Kyoungho Ryu, M.D. Kangbuk Samsung Hospital
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Responsible Party: Kyoungho Ryu, Clinical assistant professor, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT02698514    
Other Study ID Numbers: 2015-12-023
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Sevoflurane
Desflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs