- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01972230
Sevoflurane Protective Effect on Ischemia Reperfusion Injury in Microvascular Surgery
April 6, 2016 updated by: Ester Forastiere, Regina Elena Cancer Institute
This study aimed to evaluate the possible protective effect of anesthetic technique balanced (BAL) compared to total intravenous anesthetic technique (TIVA-TCI) in ischemia reperfusion injury in microvascular flap in plastic surgery.
The investigators will evaluate the viability of the flap using tissue oximetry monitoring and the level of biochemical markers in a circle at the end of the intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Not Applicable
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
-
-
RM
-
Rome, RM, Italy, 00144
- Regina Elena Cancer Institute
-
-
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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- age > 18 yr
- ASA (American Society of Anesthesiology) I-II
Exclusion Criteria:
- Known unusual reaction to anesthetic drugs
- Evaluation of anesthesia increased risk for malignant hyperthermia.
- History of vascular disease.
- History of bleeding diathesis.
- Tabagism
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bilanced group
Sevofluorane adjusted to obtain an Et-Sevo of 1.8-2%, for all the time of the surgical procedure. Remifentanyl TCI adjusted according to protocol to maintain the range of 1-3 ng / ml. |
|
Active Comparator: TCI group
Propofol 3-4 mg / ml and remifentanyl 1-3 ng / ml according to protocol TCI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
tissutal oximetry average value of the flap measured with INVOS (In Vivo Optical Spectroscopy) system continuously.
Time Frame: 24 hours from the end of intervention
|
24 hours from the end of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2013
Primary Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
October 24, 2013
First Submitted That Met QC Criteria
October 29, 2013
First Posted (Estimate)
October 30, 2013
Study Record Updates
Last Update Posted (Estimate)
April 7, 2016
Last Update Submitted That Met QC Criteria
April 6, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Anesthetics, Inhalation
- Remifentanil
- Propofol
- Sevoflurane
Other Study ID Numbers
- 17713
- Claudia (Registry Identifier: Claudia)
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.
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