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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02698514
Other study ID # 2015-12-023
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 16, 2016
Est. completion date July 13, 2016

Study information

Verified date May 2018
Source Kangbuk Samsung Hospital
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 desflurane at equi-minimum alveolar concentration using SPI and 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 desflurane at equi-minimum alveolar concentration using SPI and EEG analysis.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date July 13, 2016
Est. primary completion date July 13, 2016
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility 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

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).
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).

Locations

Country Name City State
Korea, Republic of Kangbuk Samsung Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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