Recruiting
Early Phase 1

Inhalational Anesthesia vs TIVA

Sponsor:

Our Lady of the Lake Hospital

Code:

NCT05993039

Conditions

Perforated Eardrum

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Interventions

Isoflurane Inhalant Product

Sevoflurane inhalant product

Propofol injection

Remifentanil Injection

Study Details

Brief summary:

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.

Conditions

Perforated Eardrum

Study ID

NCT05993039

Start date

Sep 1, 2023

Status verified date

Oct, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Individuals with anticoagulation disorders
  • Those receiving anticoagulation therapy currently

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Inhalational Anesthesia

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.

active comparator: Total Intravenous Anesthesia (TIVA)

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.

Interventions

Isoflurane Inhalant Product

1.5-2%

Sevoflurane inhalant product

1-2% adults 0.6-1.5% Children

Propofol injection

1mg/kg-mcg/kg/min adults 100-200mcg/kg/min children

Remifentanil Injection

0.05-2ug/kg/min adults and children

Primary outcome measure

  • Surgical Field Quality [ Time Frame: Post-Operative evaluation (within 2 weeks) ]
  • Intra-operative blood loss [ Time Frame: 1-2 hours during surgery ]

Central Contacts and Locations

Central contacts

Leslie S Son, PhD

225-765-7659Lson@lsuhsc.edu

Christine LeBoeuf, DNP

225-765-7659christine.leboeuf@fmolhs.org

Locations

Our Lady of the Lake Hospital

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Leslie Son, Ph.D.

225-757-4165lson@lsuhsc.edu

More Information

Sponsor

Our Lady of the Lake Hospital

Last update posted

Nov 1, 2023

Last verified

Oct, 2023

Keywords

  • tympanoplasty
  • Inhalational anesthesia
  • total intravenous anesthesia
  • intraoperative blood loss

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Our Lady of the Lake Hospital on 2023-11-01.