Prevention of Laryngeal Reflexes in Minimal Invasive Parathyroid Surgery by the Use of Topical Lidocaine
N/A
N/A
Both
Parathyroid Disease
Trial Information
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.
Inclusion Criteria:
- All outpatients scheduled for MIPS at the ACB by Dr N Perrier, Dr D Evans and Dr JE
Lee.
Exclusion Criteria:
- Patients who are excluded will be any who require elective endotracheal intubation as
a preoperative decision by the anesthesia team. These patients will be those with
sleep apnea, BMI>35, uncontrolled gastro esophageal reflux.
- Patients who have a history of allergy/hypersensitivity to lidocaine.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Severity of Airway Interruption
Outcome Time Frame:
Assessment made by surgeon during minimally invasive parathyroidectomy surgery
Safety Issue:
No
Principal Investigator
Spencer Kee, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2006-0147
NCT ID:
NCT00528502
Start Date:
June 2006
Completion Date:
January 2008
Related Keywords:
- Parathyroid Disease
- Parathyroid Disease
- Minimal Invasive Parathyroid Surgery
- MIPS
- Laryngeal Reflexes
- Lidocaine
- Saline
- Parathyroid Diseases
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