Inhalational Anesthesia vs TIVA for Ear Drum Perforation

(TIVA Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Rahul Mehta, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Our Lady of the Lake Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for people of any age who are scheduled to have an endoscopic tympanoplasty, which is a surgery for repairing the eardrum. It's not open to those with blood clotting disorders or anyone currently on blood thinners.

Inclusion Criteria

I am scheduled for an ear surgery to repair my eardrum.

Exclusion Criteria

I am currently on blood thinners.

Individuals with anticoagulation disorders

Participant Groups

The study compares two types of anesthesia in ear surgery: inhalational (using Isoflurane or Sevoflurane) versus total intravenous (TIVA), using Propofol and Remifentanil. It looks at surgical conditions, blood loss, emergence from anesthesia, and recovery times.

Group I: Inhalational Anesthesia Active Control 2 Interventions

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.

Group II: Total Intravenous Anesthesia (TIVA) Active Control 2 Interventions

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.

Isoflurane Inhalant Product is already approved in United States, European Union, Canada, Japan, Australia for the following indications:

🇺🇸 Approved in United States as Forane for:

• General anesthesia
• Maintenance of anesthesia

🇪🇺 Approved in European Union as Isoflurane for:

• Induction and maintenance of general anesthesia

🇨🇦 Approved in Canada as Isoflurane for:

• General anesthesia

🇯🇵 Approved in Japan as Isoflurane for:

• General anesthesia

🇦🇺 Approved in Australia as Isoflurane for:

• General anesthesia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Our Lady of the Lake Hospital Baton Rouge, LA

Who Is Running the Clinical Trial?

Our Lady of the Lake Hospital Lead Sponsor

Louisiana State University Health Sciences Center in New Orleans Collaborator

References