NCT05993039

Inhalational Anesthesia vs TIVA in Endoscopic Tympanoplasty

Comparison of Inhalational Anesthesia and Total Intravenous Anesthesia on Surgical Field Quality and Post-operative Recovery in Endoscopic Tympanoplasty

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Our Lady of the Lake Hospital · Academic / Other
• Sex: All
• Age: 0 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Perforated Eardrum

Interventions

Type	Name	Description
DRUG	Isoflurane Inhalant Product	1.5-2%
DRUG	Sevoflurane inhalant product	1-2% adults 0.6-1.5% Children
DRUG	Propofol injection	1mg/kg-mcg/kg/min adults 100-200mcg/kg/min children
DRUG	Remifentanil Injection	0.05-2ug/kg/min adults and children

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-08-15
• Last updated: 2023-11-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study