Lidocaine Supplement for Minimal Invasive Parathyroid Surgery

Phase 3

Withdrawn

• Conditions: Parathyroid Disease
• Interventions: Drug: Saline; Drug: Lidocaine

• Registration Number: NCT00528502
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

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. Up to 105 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-09-11
• Study First Submitted QC: 2007-09-11
• Study First Posted: 2007-09-12
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-05
• Last Update Posted: 2012-12-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline	Saline misted into the air breathe during the surgery.
Lidocaine	Lidocaine	Lidocaine misted into the air during the surgery.

Primary Outcome Measures

Name	Time	Method
Quality of Operative Field	Assessment made by surgeon during minimally invasive parathyroidectomy surgery
Severity of Airway Interruption	Assessment made by surgeon during minimally invasive parathyroidectomy surgery