Lidocaine Supplement for Minimal Invasive Parathyroid Surgery

Condition(s) targeted: Parathyroid Disease

Intervention: Lidocaine (Drug); Saline (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Spencer Kee, MD, Principal Investigator, Affiliation: U.T.M.D. Anderson Cancer Center

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Uncontrolled, Parallel Assignment, Efficacy Study

Primary outcome: The goal of this clinical research study is to determine if Lidocaine, given during minimally invasive parathyroidectomy surgery, will stop the interruptions to surgery caused by coughing and other throat movements.

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, the substance used will be billed to you and/or your insurance provider. Up to 105 patients will take part in this study. All will be enrolled at M. D. Anderson.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

U.T.M.D. Anderson Cancer Center, Houston, Texas 77030, United States

Starting date: June 2006
Last updated: March 10, 2008