Clinical trial

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

Name
TIVA in Ear Surgery
Description
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.
Trial arms
Trial start
2023-09-01
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Isoflurane Inhalant Product
1.5-2%
Arms:
Inhalational Anesthesia
Sevoflurane inhalant product
1-2% adults 0.6-1.5% Children
Arms:
Inhalational Anesthesia
Propofol injection
1mg/kg-mcg/kg/min adults 100-200mcg/kg/min children
Arms:
Total Intravenous Anesthesia (TIVA)
Remifentanil Injection
0.05-2ug/kg/min adults and children
Arms:
Total Intravenous Anesthesia (TIVA)
Size
100
Primary endpoint
Surgical Field Quality
Post-Operative evaluation (within 2 weeks)
Intra-operative blood loss
1-2 hours during surgery
Eligibility criteria
Inclusion Criteria: * Individuals of all ages * Scheduled to undergo an endoscopic tympanoplasty Exclusion Criteria: * Individuals with anticoagulation disorders * Those receiving anticoagulation therapy currently
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double-blinded randomized control', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-11-01

1 organization

4 products

1 indication

Product
Isoflurane
Product
Propofol