Ignite Creation Date:
2024-05-06 @ 1:04 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01727557
Status:
TERMINATED
Last Update Posted:
2018-03-05
First Post:
2012-06-08
Brief Title:
Anesthetic Technique for AV Fistulae Creation
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low Accural Rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to compare the two anesthesia techniques which are commonly used in the formation of arteriovenous fistulas local anesthesia and regional anesthesia Local anesthesia means that your doctor will inject numbing medication directly into the tissue or part of your body where the surgery will be done In this case the numbing medication will be injected directly into the area where your fistula will be made In regional anesthesia the numbing medication will be injected around the nerve part of the body that gives sensation for your arm to make the entire arm numb The purpose of this study is to compare the three month success rates of AV fistulae created by the two anesthesia techniques
Detailed Description:
The primary objectives of the study are
1 To evaluate the three-month success rate for AV fistulas constructed while using regional anesthesia against those constructed while using local anesthesia Success will be evaluated by a dialysis access ultrasound which will be performed three months after completion of the procedure Successful will be defined as a mean blood flow of 600 mlmin and above or receiving hemodialysis using the newly created AV fistula
2 To evaluate the immediate within 3 days and long-term complications three months after AV fistula construction under regional anesthesia or local anesthesia
The secondary objective of the study is to use a short questionnaire survey To assess patient comfort level after creation of AV fistula eg nausea analgesia
1 To evaluate the three-month success rate for AV fistulas constructed while using regional anesthesia against those constructed while using local anesthesia Success will be evaluated by a dialysis access ultrasound which will be performed three months after completion of the procedure Successful will be defined as a mean blood flow of 600 mlmin and above or receiving hemodialysis using the newly created AV fistula
2 To evaluate the immediate within 3 days and long-term complications three months after AV fistula construction under regional anesthesia or local anesthesia
The secondary objective of the study is to use a short questionnaire survey To assess patient comfort level after creation of AV fistula eg nausea analgesia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None