Inhalational Anesthesia vs TIVA in Endoscopic Tympanoplasty
NCT05993039 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2023-11-01
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
Interventions
- 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
Sponsors & Collaborators
-
Louisiana State University Health Sciences Center in New Orleans
collaborator OTHER -
Our Lady of the Lake Hospital
lead OTHER
Principal Investigators
-
Rahul Mehta, MD · Our Lady of the Lake Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 0 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-01
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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