- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02609802
The Different Analgesic Potency of Volatile Anesthetics at Equi-MAC
November 6, 2017 updated by: Kyoungho Ryu, Kangbuk Samsung Hospital
The Different Analgesic Potency of Sevoflurane and Desflurane at Equi-minimum Alveolar Concentration
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 03181
- Kangbuk Samsung Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sevoflurane
Anesthesia was maintained with sevoflurane.
|
Anesthesia was maintained with sevoflurane in patients undergoing arthroscopic shoulder surgery under general anesthesia and interscalene brachial plexus block.
Other Names:
|
Experimental: Desflurane
Anesthesia was maintained with desflurane.
|
Anesthesia was maintained with desflurane in patients undergoing arthroscopic shoulder surgery under general anesthesia and interscalene brachial plexus block.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analgesic potency of volatile anesthetics
Time Frame: the first 60 min of maintaining a steady state 1 MAC of volatile agents
|
The analgesic potency was evaluated by surgical pleth index value
|
the first 60 min of maintaining a steady state 1 MAC of volatile agents
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kyoungho Ryu, M.D., Kangbuk Samsung Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
July 28, 2016
Study Completion (Actual)
July 28, 2016
Study Registration Dates
First Submitted
November 18, 2015
First Submitted That Met QC Criteria
November 18, 2015
First Posted (Estimate)
November 20, 2015
Study Record Updates
Last Update Posted (Actual)
November 8, 2017
Last Update Submitted That Met QC Criteria
November 6, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-09-028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Orthopedic Disorders
-
Istituto Ortopedico RizzoliCompleted
-
Hadassah Medical OrganizationUnknownOrthopedic DisordersIsrael
-
University Hospital of North NorwayHelse NordCompleted
-
Boston Medical CenterRecruiting
-
St. Luke's-Roosevelt Hospital CenterCompletedOrthopedic DisordersUnited States
-
McGill University Health Centre/Research Institute...CompletedTrauma | Orthopedic DisordersCanada
-
University of Texas at AustinCompleted
-
Huub van HedelCompletedCentral Motor Disorders | Orthopedic DisordersSwitzerland
-
Emory UniversityCompletedTibial Fractures | Orthopedic DisordersUnited States
-
Hopital FochCompleted
Clinical Trials on Sevoflurane
-
Yeungnam University College of MedicineCompleted
-
University of RostockCompletedOther Specified Injuries of Vocal Cord, SequelaGermany
-
Assistance Publique - Hôpitaux de ParisMinistry of Health, FranceTerminated
-
Kocaeli Derince Education and Research HospitalCompleted
-
Pontificia Universidad Catolica de ChileUnknown
-
Universiti Sains MalaysiaCompletedGeneral Anaesthesia | PaediatricsMalaysia
-
University Hospital, Clermont-FerrandCompleted
-
University Hospital, GhentCompleted
-
China International Neuroscience InstitutionCompletedGeneral Anesthesia | Urinary SurgeryChina