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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02830243
Other study ID # 2016-05-058
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 12, 2016
Est. completion date October 8, 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 purpose of this clinical trial is to compare analgesic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using surgical pleth index.


Description:

Volatile anesthetics vary in their relative hypnotic potency. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetic agents may produce different bispectral index values. However, the difference between analgesic effects of volatile anesthetics have not yet been investigated. The purpose of this clinical trial is to compare analgesic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using surgical pleth index-guided remifentanil infusion.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date October 8, 2016
Est. primary completion date October 5, 2016
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria:

- patients undergoing balanced general anesthesia using volatile anesthetics and remifentanil

- 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
End-tidal concentration of sevoflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period. The remifentanil infusion rate was adjusted using TCI pump to achieve surgical pleth index between 20 and 50.
Desflurane
End-tidal concentration of desflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period. The remifentanil infusion rate was adjusted using TCI pump to achieve surgical pleth index between 20 and 50.

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 Remifentanil consumption (µg/kg/min) During the intraoperative period
Secondary Target effective site concentration of remifentanil (ng/ml) After at least 10 min of stable surgical pleth index values
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