Inhalational Anesthesia vs TIVA in Endoscopic Tympanoplasty
NCT ID: NCT05993039
Last Updated: 2023-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
100 participants
INTERVENTIONAL
2023-09-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Inhalational Anesthesia
Adults:
The control group will receive general inhalational anesthesia (sevoflurane, isoflurane). The will be induced with fentanyl 1-2µg/kg, propofol 2mg/kg, lidocaine 1mg/kg. After orotracheal intubation, anesthesia will be maintained with isoflurane 1.5-2% or sevoflurane 1-2%.
Children (12 or younger) induced with a combination of volatile anesthetic gases, including sevoflurane (up to 8%) and nitrous oxide gas (up to 70%). Those who are older than 12 will have an intravenous line placed in the preoperative area and as such will be induced with remifentanil and propofol as above. For maintenance, children in the control arm will receive 0.6 - 1.5% sevoflurane.
Isoflurane Inhalant Product
1.5-2%
Sevoflurane inhalant product
1-2% adults 0.6-1.5% Children
Total Intravenous Anesthesia (TIVA)
Adults:
The comparator arm will receive total intravenous anesthesia (propofol and remifentanil). They will be induced with fentanyl 1-2µg/kg, propofol 2mg/kg, and lidocaine 1mg/kg. After orotracheal intubation, anesthesia will be maintained with propofol 100-200mcg/kg/min, remifentanil 0.05-2µg/kg/min.
Children (12 or younger) induced with a combination of volatile anesthetic gases, including sevoflurane (up to 8%) and nitrous oxide gas (up to 70%). Those who are older than 12 will have an intravenous line placed in the preoperative area and as such will be induced with remifentanil and propofol as above. For maintenance, they will receive 100-200mcg/min propofol and 0.05-2µg/kg/min remifentanil.
Propofol injection
1mg/kg-mcg/kg/min adults 100-200mcg/kg/min children
Remifentanil Injection
0.05-2ug/kg/min adults and children
Interventions
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Isoflurane Inhalant Product
1.5-2%
Sevoflurane inhalant product
1-2% adults 0.6-1.5% Children
Propofol injection
1mg/kg-mcg/kg/min adults 100-200mcg/kg/min children
Remifentanil Injection
0.05-2ug/kg/min adults and children
Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo an endoscopic tympanoplasty
Exclusion Criteria
* Those receiving anticoagulation therapy currently
0 Years
100 Years
ALL
No
Sponsors
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Louisiana State University Health Sciences Center in New Orleans
OTHER
Our Lady of the Lake Hospital
OTHER
Responsible Party
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Leslie Son
Research Scientist-Study Coordinator
Principal Investigators
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Rahul Mehta, MD
Role: PRINCIPAL_INVESTIGATOR
Our Lady of the Lake Hospital
Locations
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Our Lady of the Lake Hospital
Baton Rouge, Louisiana, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TIVA in Ear Surgery
Identifier Type: -
Identifier Source: org_study_id
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