Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434636
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-19
Brief Title:
The Effect of Tranexamic Acid in Endoscopic and Microscopic Ear Surgery Cases on Surgeon Satisfaction
Sponsor:
TC Erciyes University
Organization:
TC Erciyes University
Study Overview
Official Title:
The Effect of The Use of Low Dose Tranexamic Acid on Surgeon Satisfaction Side Effects and Complications in Endoscopic and Microscopic Ear Surgery Cases Which Are Used With Controlled Hypotension
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
By using tranexamic acid an antifibrinolytic drug the aim is to prevent the restriction of the field of view of the surgical field due to bleeding in middle ear microscopic and endoscopic surgery operations in which controlled hypotension is applied and therefore the prolongation of the surgical time and to increase surgeon satisfaction
Detailed Description:
After obtaining approval from our university and the Turkish Ministry of Healths pharmaceutical and medical device agency and written consent from the patients 100 patients who underwent middle ear surgery using controlled hypotension under general anesthesia will be included in the study
The study will be conducted in a randomized controlled double-blind manner Patients between the ages of 18-65 and with American Society of Anesthesiologists ASA Scores I and II will be included in the study Patients will be divided into two groups Intervention M and Control C Just before the operation begins 10 mgkg tranexamic acid TXA will be administered to the intervention group in 100 mL of 09 physiological saline SF solution in 15 minutes 100 mL of 09 SF solution will be sent to the control group in 15 minutes At the end of the operation the operators quality of vision of the surgical field will be recorded by questioning the surgeons satisfaction with the Boezaart Score and the Surgeon Satisfaction Score
The study will be conducted in a randomized controlled double-blind manner Patients between the ages of 18-65 and with American Society of Anesthesiologists ASA Scores I and II will be included in the study Patients will be divided into two groups Intervention M and Control C Just before the operation begins 10 mgkg tranexamic acid TXA will be administered to the intervention group in 100 mL of 09 physiological saline SF solution in 15 minutes 100 mL of 09 SF solution will be sent to the control group in 15 minutes At the end of the operation the operators quality of vision of the surgical field will be recorded by questioning the surgeons satisfaction with the Boezaart Score and the Surgeon Satisfaction Score
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None