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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03588429
Other study ID # 2018CZTCWM
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 1, 2020
Est. completion date December 1, 2020

Study information

Verified date August 2018
Source Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date December 1, 2020
Est. primary completion date August 1, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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).
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).

Locations

Country Name City State
China Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine Cangzhou Hebei

Sponsors (1)

Lead Sponsor Collaborator
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary qCON index The hypnotic potency of volatile anesthetics was evaluated by qCON index during standardized nociceptive stimulus (30 s, 50 mA, 50 Hz tetanic stimulation). the 10 min at steady-state anesthesia after endotracheal intubation
Secondary qNOX index The analgesic potency of volatile anesthetics was evaluated by qNOX index during standardized nociceptive stimulus (30 s, 50 mA, 50 Hz tetanic stimulation). the 10 min at steady-state anesthesia after endotracheal intubation
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