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The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03588429
Recruitment Status : Suspended (Researchers go abroad to study)
First Posted : July 17, 2018
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

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
Anesthesia Drug: Sevoflurane Drug: Isoflurane 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


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: 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 Name: ISO




Primary Outcome Measures :
  1. qCON index [ Time Frame: 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 [ Time Frame: 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).



Information from the National Library of Medicine

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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 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

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): NCT03588429


Locations
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China, Hebei
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
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Principal Investigator: Ruizhao Lv, M.D Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
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Responsible Party: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
ClinicalTrials.gov Identifier: NCT03588429    
Other Study ID Numbers: 2018CZTCWM
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: August 2018

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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:
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Sevoflurane
Isoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs