Lidocaine Supplement for Minimal Invasive Parathyroid Surgery
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|ClinicalTrials.gov Identifier: NCT00528502|
Recruitment Status : Withdrawn (Terminated due to no patient enrollment.)
First Posted : September 12, 2007
Last Update Posted : December 7, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Parathyroid Disease||Drug: Lidocaine Drug: Saline||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Prevention of Laryngeal Reflexes in Minimal Invasive Parathyroid Surgery by the Use of Topical Lidocaine|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
Saline misted into the air breathe during the surgery.
Saline is misted into the air that you breathe during the surgery.
Lidocaine misted into the air during the surgery.
Lidocaine is misted into the air that you breathe during the surgery.
- Severity of Airway Interruption [ Time Frame: Assessment made by surgeon during minimally invasive parathyroidectomy surgery ]
- Quality of Operative Field [ Time Frame: Assessment made by surgeon during minimally invasive parathyroidectomy surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528502
|Principal Investigator:||Spencer Kee, MD||M.D. Anderson Cancer Center|