Comparison of Inhalational Anesthesia and Total Intravenous Anesthesia on Surgical Field Quality and Post-operative Recovery in Endoscopic Tympanoplasty
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
This study aims to prospectively compare surgical field quality and intraoperative blood loss between general inhalational anesthesia to total intravenous anesthesia (TIVA) alone in subjects undergoing endoscopic ear surgery. A secondary objective is to compare rates of emergence delirium and total recovery time between the two groups.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 100
Healthy Volunteers: f
View:
• Individuals of all ages
• Scheduled to undergo an endoscopic tympanoplasty
Locations
United States
Louisiana
Our Lady of the Lake Hospital
RECRUITING
Baton Rouge
Contact Information
Primary
Leslie S Son, PhD
Lson@lsuhsc.edu
225-765-7659
Backup
Christine LeBoeuf, DNP
christine.leboeuf@fmolhs.org
225-765-7659
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 100
Treatments
Active_comparator: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Our Lady of the Lake Hospital
Collaborators: Louisiana State University Health Sciences Center in New Orleans