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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores which type of anesthesia is better for individuals undergoing surgery to repair a perforated (torn) eardrum. It compares inhalational anesthesia (breathing in gases like Isoflurane and Sevoflurane) with total intravenous anesthesia (TIVA, which involves receiving drugs through a vein, such as Propofol and Remifentanil). The researchers aim to determine which method provides better surgical conditions, reduces blood loss, and affects recovery time and post-operative confusion. Individuals requiring endoscopic ear surgery without blood-clotting issues may be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how these anesthesia methods work in people, offering participants the chance to contribute to pioneering medical insights.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on anticoagulation therapy, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that isoflurane and sevoflurane, used to help patients sleep during surgery, are generally safe for ear surgeries. One study found that isoflurane is safer for ear, nose, and throat procedures because it causes less pressure in the middle ear than sevoflurane, reducing the risk of ear problems during surgery.

For total intravenous anesthesia (TIVA), which uses drugs like propofol and remifentanil, past use has demonstrated safety. These drugs often keep patients asleep without gas and help them wake up and recover quickly after surgery.

Although this study is in an early phase, with safety still under careful review, both types of anesthesia have been used in many surgeries before, suggesting they are generally well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores two different anesthesia approaches for ear drum perforation surgeries: inhalational anesthesia and total intravenous anesthesia (TIVA). Inhalational anesthesia uses gases like sevoflurane and isoflurane, which are inhaled to maintain anesthesia. This method is known for its ease of control and rapid adjustment during surgery. On the other hand, TIVA relies on propofol and remifentanil administered intravenously, offering a potentially smoother recovery with less nausea and a more predictable depth of anesthesia. By comparing these two methods, researchers hope to determine which approach provides better outcomes and comfort for patients, offering tailored anesthesia solutions for ear surgeries.

What evidence suggests that this trial's treatments could be effective for ear drum perforation?

This trial will compare inhalational anesthesia with total intravenous anesthesia (TIVA) for ear drum perforation surgeries. Studies have shown that isoflurane, used for inhalational anesthesia, effectively supports ear, nose, and throat (ENT) surgeries. It reduces middle ear pressure more than sevoflurane, making it a safe option for these procedures. Meanwhile, research indicates that a combination of propofol and remifentanil in TIVA reduces blood loss during surgery, benefiting patients undergoing ear surgeries. Both treatments have demonstrated strengths in different areas of surgical care. ^{2 4 6 7 8}

Who Is on the Research Team?

Rahul Mehta, MD

Principal Investigator

Our Lady of the Lake Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ijlbpr.com ijlbpr.com/uploadfiles/vol5issue3pp1-4.20241029072307.pdf

Effect of Sevoflurane versus isoflurane on middle ear ... Authors found that since the rise in middle ear pressure under isoflurane anesthesia was less than that of sevoflurane, it can be used safely for ENT procedures ...

2. mdpi.com mdpi.com/2077-0383/10/7/1541

Effect of Growth Factor-Loaded Acellular Dermal Matrix ... The success rate of grafting using acellular dermal matrix (ADM) for chronic tympanic membrane was reported in previous studies to be lower than fascia or ...

3. go.drugbank.com go.drugbank.com/drugs/DB00753/clinical_trials?conditions=DBCOND0108633&phase=1&purpose=treatment&status=recruiting

Isoflurane Recruiting Phase 1 Trials for perforated eardrum ... Isoflurane Recruiting Phase 1 Trials for perforated eardrum Treatment ; NCT05993039. Inhalational Anesthesia vs TIVA in Endoscopic Tympanoplasty. Isoflurane ( ...

4. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/483869

Intravenous Sedation vs General Anesthesia for Pediatric ... Main Outcome Measures Procedure completion rate, tympanic membrane perforation rate after ear procedures, complications, and hospital charges. Results Of ...

5. nature.com nature.com/articles/s41536-023-00332-0

Epimorphic regeneration in the mammalian tympanic ... We demonstrate that the TM repairs itself through a process that bears many hallmarks of epimorphic regeneration rather than typical wound healing.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32949927/

Probabilistic health risk assessment of occupational ... Moreover, the estimated non-cancer risk due to isoflurane is above the acceptable value for anesthesiologists (but acceptable for other ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7808081/

Anaesthesia for major middle ear surgery - PubMed Central This article will review the anatomy, pathology, and surgical considerations relevant to major middle ear procedures, and the implications for the anaesthetist.

8. researchgate.net researchgate.net/publication/12353575_Effect_of_Tympanic_Perforations_on_the_Detection_of_Distortion-product_Otoacoustic_Emissions

Effect of Tympanic Perforations on the Detection ... We found that small perforations, up to 25% of the area of the tympanic membrane, still allow us to detect emissions at the specified ...