Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Sphenopalatine Artery Location and Patency in Harvesting and Positioning a Pedicled Nasoseptal Mucosal Flap in Endoscopic Endonasal Cranial Base Surgery
Overview
- Phase
- Not Applicable
- Intervention
- indocyanine green
- Conditions
- Skull Base Neoplasms
- Sponsor
- Ohio State University
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Number of Participants for Which Angiograghy is Used to Visualize Nasoseptal Mucosa Better Than What is Done Standard of Care in This Surgery.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This is a feasibility study in which indocyanine green (ICG) will be administered during routine expanded endonasal approach (EEA) for cranial base pathologies in which a nasoseptal flap harvest will be necessary. The research entails administering ICG, which is already widely used during open neurosurgical procedures, to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
Detailed Description
This study is being done to determine if it is feasible to use angiography during endo-nasal surgery. During the angiography indocyanine green (ICG) will be injected into the patients IV tubing to help see the arteries. ICG is routinely used in vascular surgeries on the brain but not for endo-nasal surgery. The purpose of this study is to see how well intraoperative angiography using ICG can be done during endonasal surgery.
Investigators
Daniel Prevedello
Associate Professor
Ohio State University
Eligibility Criteria
Inclusion Criteria
- •Age 18 and above
- •Patients undergoing an EEA for cranial base pathology that may require nasoseptal flap harvest
Exclusion Criteria
- •History of sulfa, iodide, or penicillin allergy
- •Pregnant or breast feeding
- •Preoperative lack of indication for nasoseptal flap harvest
- •Previous anaphylactic reaction to ICG
Arms & Interventions
ICG
Angiography with administered ICG
Intervention: indocyanine green
Outcomes
Primary Outcomes
Number of Participants for Which Angiograghy is Used to Visualize Nasoseptal Mucosa Better Than What is Done Standard of Care in This Surgery.
Time Frame: During surgery
The researcher will administer ICG, which is already widely used during open neurosurgical procedures, to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case. This study will determine feasibility of other larger clinical trials using this method.