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Prevention of Laryngeal Reflexes in Minimal Invasive Parathyroid Surgery by the Use of Topical Lidocaine

Phase 3
Not Enrolling
Parathyroid Disease

Thank you

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

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:


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:


Principal Investigator

Spencer Kee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




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