Prevention of Laryngeal Reflexes in Minimal Invasive Parathyroid Surgery by the Use of Topical Lidocaine
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Severity of Airway Interruption
Assessment made by surgeon during minimally invasive parathyroidectomy surgery
No
Spencer Kee, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Institutional Review Board
2006-0147
NCT00528502
June 2006
January 2008
Name | Location |
---|