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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-2 hours during surgery

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intra-operative blood loss

Surgical Field Quality

Secondary study objectives

Emergent Delirium and Recovery Time-Richmond Scale

Emergent Delirium and Recovery Time-Riker Scale

Post-operative pain or complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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