Inhalational Anesthesia vs TIVA in Endoscopic Tympanoplasty

Our Lady of the Lake Hospital

Status and phase: Enrolling; Early Phase 1

Conditions: Perforated Eardrum

Treatments: Drug: Remifentanil Injection; Drug: Propofol injection; Drug: Isoflurane Inhalant Product; Drug: Sevoflurane inhalant product

Study type: Interventional

Funder types: Other

Identifiers

NCT05993039

TIVA in Ear Surgery

Details and patient eligibility

About

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.

Full description

In sinus surgery, TIVA has been described as a possible advantage in the use of endoscopic ear surgery. However, to date, there are no studies that examine blood loss, surgical field quality, and recovery in TIVA compared to inhalational anesthesia in the setting of endoscopic ear surgery. The hypothesis is that in patients who undergo endoscopic tympanoplasty, those who receive TIVA will have reduced intraoperative blood loss, improved surgical field quality, and reduced emergence agitation than those who receive inhalational anesthesia. This study will be a prospective double-blinded randomized control trial consisting of subjects undergoing endoscopic tympanoplasty surgery to assess intraoperative blood loss, surgical field quality, rates of emergence delirium, and recovery time.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals of all ages
• Scheduled to undergo an endoscopic tympanoplasty

Exclusion criteria

• Individuals with anticoagulation disorders
• Those receiving anticoagulation therapy currently

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Inhalational Anesthesia

Active Comparator group

Description:

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.

Treatment:

Drug: Sevoflurane inhalant product

Drug: Isoflurane Inhalant Product

Total Intravenous Anesthesia (TIVA)

Active Comparator group

Description:

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.

Treatment:

Drug: Remifentanil Injection

Drug: Propofol injection