Ignite Creation Date:
2024-05-05 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00528502
Status:
WITHDRAWN
Last Update Posted:
2012-12-07
First Post:
2007-09-11
Brief Title:
Lidocaine Supplement for Minimal Invasive Parathyroid Surgery
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Prevention of Laryngeal Reflexes in Minimal Invasive Parathyroid Surgery by the Use of Topical Lidocaine
Status:
WITHDRAWN
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to no patient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
1 To determine if the application of lidocaine to the airway will obtund or abolish the laryngeal reflexes This in turn will lead to a quiescent controlled surgical field
1 To determine if the application of lidocaine to the airway will obtund or abolish the laryngeal reflexes This in turn will lead to a quiescent controlled surgical field
Detailed Description:
Lidocaine is a local anesthetic that causes numbness to the throat when misted into the air This numbness in the throat should stop the urge to clear the throat in the middle of the operation Therefore this should stop the interruptions during the surgery
If you agree to take part in this study you will be randomly assigned as in the toss of a coin to one of 2 groups Participants in Group 1 will receive the saline mist This will moisturize and soothe the throat Participants in Group 2 will receive the lidocaine mist Lidocaine or saline is misted into the air that you breathe during the surgery You and your surgeon will not be told which group you were assigned to At the end of the surgery your surgeon will answer some questions to help determine if the use of lidocaine or saline is beneficial
You will be considered off-study once you are sent to the recovery room after surgery
This is an investigational study Lidocaine is FDA-approved and commercially available for local anesthesia If you are in the lidocaine or the saline group Up to 105 patients will take part in this study All will be enrolled at M D Anderson
If you agree to take part in this study you will be randomly assigned as in the toss of a coin to one of 2 groups Participants in Group 1 will receive the saline mist This will moisturize and soothe the throat Participants in Group 2 will receive the lidocaine mist Lidocaine or saline is misted into the air that you breathe during the surgery You and your surgeon will not be told which group you were assigned to At the end of the surgery your surgeon will answer some questions to help determine if the use of lidocaine or saline is beneficial
You will be considered off-study once you are sent to the recovery room after surgery
This is an investigational study Lidocaine is FDA-approved and commercially available for local anesthesia If you are in the lidocaine or the saline group Up to 105 patients will take part in this study All will be enrolled at M D Anderson
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