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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02609802
Other study ID # 2015-09-028
Secondary ID
Status Completed
Phase Phase 3
First received November 18, 2015
Last updated November 6, 2017
Start date November 2015
Est. completion date July 28, 2016

Study information

Verified date November 2017
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 difference of analgesic potency of sevoflurane and desflurane at equi-minimum alveolar concentration using a surgical pleth index.


Description:

Volatile anesthetics vary in their relative hypnotic potencies. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetics produced different EEG-derived indices such as bispectral index. However, there was no controlled study that demonstrates the difference of analgesic potency. The aim of this clinical trial is to evaluate the difference of analgesic potency of sevoflurane and desflurane at equi-minimum alveolar concentration using a surgical pleth index.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date July 28, 2016
Est. primary completion date July 28, 2016
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria:

- patients undergoing arthroscopic shoulder surgery

- 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 who have not received interscalene approach brachial plexus block (refusal or failure)

- pregnant women

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sevoflurane
Anesthesia was maintained with sevoflurane in patients undergoing arthroscopic shoulder surgery under general anesthesia and interscalene brachial plexus block.
Desflurane
Anesthesia was maintained with desflurane in patients undergoing arthroscopic shoulder surgery under general anesthesia and interscalene brachial plexus block.

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 Analgesic potency of volatile anesthetics The analgesic potency was evaluated by surgical pleth index value the first 60 min of maintaining a steady state 1 MAC of volatile agents
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