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Anesthesia

Inhalational Anesthesia vs TIVA for Ear Drum Perforation (TIVA Trial)

Phase < 1
Recruiting
Led By Rahul Mehta, MD
Research Sponsored by Our Lady of the Lake Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-1 hour post-operative
Awards & highlights

TIVA Trial Summary

This trial compares general anesthesia to TIVA in endoscopic ear surgery. It will also measure emergence delirium and recovery time.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include nausea, vomiting, throat discomfort from the breathing tube used during general anesthesia, dizziness upon waking up (emergence delirium), and variations in recovery time post-surgery.

TIVA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 hours during surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 hours during surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intra-operative blood loss
Surgical Field Quality
Secondary outcome measures
Emergent Delirium and Recovery Time-Richmond Scale
Emergent Delirium and Recovery Time-Riker Scale
Post-operative pain or complications

TIVA Trial Design

2Treatment groups
Active Control
Group I: Inhalational AnesthesiaActive Control2 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 Control2 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.

Find a Location

Who is running the clinical trial?

Our Lady of the Lake HospitalLead Sponsor
12 Previous Clinical Trials
739 Total Patients Enrolled
Louisiana State University Health Sciences Center in New OrleansOTHER
114 Previous Clinical Trials
44,101 Total Patients Enrolled
Rahul Mehta, MDPrincipal InvestigatorOur Lady of the Lake Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I be considered an applicant for this experiment?

"This experiment is open to 100 qualified candidates with a perforated tympanic membrane ranging from infancy to age one-hundred. To be eligible, participants must meet the following criteria: all ages are welcome and they need to have an upcoming procedure for endoscopic tympanoplasty."

Answered by AI

Is the eligibility age for this research trial restricted to those above twenty-five?

"This medical study has a broad age range of 0 to 100 years old. For minors, there is a seperate trial and 3 other trials for senior citizens above the age of 65."

Answered by AI

Are there still openings available for those wanting to participate in this research?

"Indeed, the clinicaltrials.gov site displays that this research endeavor is still in need of participants. It was first made available on September 1st 2023 and has been recently updated on October 30th 2023 with a goal to recruit 100 individuals from one single medical centre."

Answered by AI

What is the current admission capacity for this clinical trial?

"Affirmative. Documents on clinicaltrials.gov illustrate that this medical study has been recruiting since it's publication date of September 1st 2023 and is still seeking participants as of October 30th 2023. The trial aims to enroll a total of 100 patients from one particular site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Inhalational Anesthesia vs TIVA in Endoscopic Tympanoplasty
Leslie Son 2023. "Inhalational Anesthesia vs TIVA in Endoscopic Tympanoplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05993039.
~53 spots leftby Dec 2024
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