Inhalational Anesthesia vs TIVA for Ear Drum Perforation

(TIVA Trial)

Overseen By Christine LeBoeuf, DNP

Age: Any Age

Sex: Any

Trial Phase: Phase < 1

Sponsor: Our Lady of the Lake Hospital

Must not be taking: Anticoagulants

Disqualifiers: Anticoagulation disorders

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1-2 hours

100 Participants Needed

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.

Research Team

Rahul Mehta, MD

Principal Investigator

Our Lady of the Lake Hospital

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endoscopic tympanoplasty with either inhalational anesthesia or total intravenous anesthesia (TIVA)

1-2 hours

1 visit (in-person)

Post-operative Recovery

Participants are monitored for emergence delirium and recovery time using the Riker and Richmond scales immediately after extubation

0-1 hour

1 visit (in-person)

Follow-up

Participants are monitored for post-operative pain, complications, and adverse events

30 days

Treatment Details

Interventions

• Isoflurane Inhalant Product
• Propofol injection
• Remifentanil Injection
• Sevoflurane inhalant product

Trial Overview 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.

Participant Groups

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 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

Who Is Running the Clinical Trial?

Our Lady of the Lake Hospital

Lead Sponsor

Trials

15

Recruited

900+

Louisiana State University Health Sciences Center in New Orleans

Collaborator

Trials

123

Recruited

42,400+