The Different Analgesic Potency of Volatile Anesthetics at Equi-MAC
Primary Purpose
Orthopedic Disorders
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sevoflurane
Desflurane
Sponsored by
About this trial
This is an interventional prevention trial for Orthopedic Disorders
Eligibility Criteria
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
Sites / Locations
- Kangbuk Samsung Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sevoflurane
Desflurane
Arm Description
Anesthesia was maintained with sevoflurane.
Anesthesia was maintained with desflurane.
Outcomes
Primary Outcome Measures
Analgesic potency of volatile anesthetics
The analgesic potency was evaluated by surgical pleth index value
Secondary Outcome Measures
Full Information
NCT ID
NCT02609802
First Posted
November 18, 2015
Last Updated
November 6, 2017
Sponsor
Kangbuk Samsung Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02609802
Brief Title
The Different Analgesic Potency of Volatile Anesthetics at Equi-MAC
Official Title
The Different Analgesic Potency of Sevoflurane and Desflurane at Equi-minimum Alveolar Concentration
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
July 28, 2016 (Actual)
Study Completion Date
July 28, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kangbuk Samsung Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sevoflurane
Arm Type
Experimental
Arm Description
Anesthesia was maintained with sevoflurane.
Arm Title
Desflurane
Arm Type
Experimental
Arm Description
Anesthesia was maintained with desflurane.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
SEVO
Intervention Description
Anesthesia was maintained with sevoflurane in patients undergoing arthroscopic shoulder surgery under general anesthesia and interscalene brachial plexus block.
Intervention Type
Drug
Intervention Name(s)
Desflurane
Other Intervention Name(s)
DES
Intervention Description
Anesthesia was maintained with desflurane in patients undergoing arthroscopic shoulder surgery under general anesthesia and interscalene brachial plexus block.
Primary Outcome Measure Information:
Title
Analgesic potency of volatile anesthetics
Description
The analgesic potency was evaluated by surgical pleth index value
Time Frame
the first 60 min of maintaining a steady state 1 MAC of volatile agents
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyoungho Ryu, M.D.
Organizational Affiliation
Kangbuk Samsung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Different Analgesic Potency of Volatile Anesthetics at Equi-MAC
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