Inhalational Anesthesia vs TIVA in Endoscopic Tympanoplasty

Last updated: October 30, 2023
Sponsor: Our Lady of the Lake Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Hearing Loss

Ear Infections (Pediatric)

Otitis Media

Treatment

Sevoflurane inhalant product

Remifentanil Injection

Isoflurane Inhalant Product

Clinical Study ID

NCT05993039
TIVA in Ear Surgery
  • Ages < 100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Individuals with anticoagulation disorders
  • Those receiving anticoagulation therapy currently

Study Design

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Sevoflurane inhalant product
Phase: 1
Study Start date:
September 01, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Our Lady of the Lake Hospital

    Baton Rouge, Louisiana 70808
    United States

    Active - Recruiting

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