Inhalational Anesthesia vs TIVA in Endoscopic Tympanoplasty

NCT05993039 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: TIVA in Ear Surgery
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Surgical Field Quality

  Neurotologists will evaluate endoscopic video clips from each surgery to assess clarity of field at different points in the surgery using the Boezaart scale grading system. It is a scale from 0-5, with 0 being the most favorable outcome and 5 being the least favorable outcome.

  Post-Operative evaluation (within 2 weeks)

• Intra-operative blood loss

  Intraoperative blood loss will be determined by measuring the total number of pledgets needed to attain hemostatsis. This will be a general observation with the more pledgets needed to stop bleeding in the surgical area indicates more possible blood loss than the procedures with that require less pledgets.

  1-2 hours during surgery

Secondary Outcomes (3)

• Emergent Delirium and Recovery Time-Riker Scale

  Immediately After extubation

• Emergent Delirium and Recovery Time-Richmond Scale

  Immediately After extubation

• Post-operative pain or complications

  0-1 hour post-operative

Study Arms (2)

Inhalational Anesthesia

ACTIVE COMPARATOR

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.

Drug: Isoflurane Inhalant Product; Drug: Sevoflurane inhalant product

Total Intravenous Anesthesia (TIVA)

ACTIVE COMPARATOR

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.

Drug: Propofol injection; Drug: Remifentanil Injection

Interventions

Isoflurane Inhalant Product DRUG

1.5-2%

Inhalational Anesthesia

Sevoflurane inhalant product DRUG

1-2% adults 0.6-1.5% Children

Inhalational Anesthesia

Propofol injection DRUG

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

Total Intravenous Anesthesia (TIVA)

Remifentanil Injection DRUG

0.05-2ug/kg/min adults and children

Total Intravenous Anesthesia (TIVA)

Eligibility Criteria

• Age: 0 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Individuals with anticoagulation disorders
• Those receiving anticoagulation therapy currently

Sponsors & Collaborators

• Our Lady of the Lake Hospital: lead
• Louisiana State University Health Sciences Center in New Orleans: collaborator

Study Sites (1)

Our Lady of the Lake Hospital

Baton Rouge, Louisiana, 70808, United States

RECRUITING

MeSH Terms

Conditions

Tympanic Membrane Perforation

Interventions

Propofol; Remifentanil

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rahul Mehta, MD

  Our Lady of the Lake Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie S Son, PhD

CONTACT

225-765-7659; Lson@lsuhsc.edu

Christine LeBoeuf, DNP

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: In the operating room, in order to blind the surgeon to the type of anesthesia used, a surgical drape will be placed in between the subject and the anesthesia team to conceal the anesthesia machinery and equipment. A sham intravenous pole will be at the anesthesia workstation for those subjects in the control arm to contribute to the blinding of the surgeon. Patients will not be informed about which arm they are randomly assigned to and only the anesthesiologist will be aware prior to the surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist-Study Coordinator

Model Details: double-blinded randomized control

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 15, 2023
• Study Start: September 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)