Lidocaine Supplement for Minimal Invasive Parathyroid Surgery

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00528502

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

Primary Objective:

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

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Jan 1, 2008

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Saline Saline misted into the air breathe during the surgery.	Drug: Saline Saline is misted into the air that you breathe during the surgery.
Experimental: Lidocaine Lidocaine misted into the air during the surgery.	Drug: Lidocaine Lidocaine is misted into the air that you breathe during the surgery.

Arm

Intervention/Treatment

Experimental: Saline

Saline misted into the air breathe during the surgery.

Drug: Saline

Saline is misted into the air that you breathe during the surgery.

Experimental: Lidocaine

Lidocaine misted into the air during the surgery.

Drug: Lidocaine

Lidocaine is misted into the air that you breathe during the surgery.

Outcome Measures

Primary Outcome Measures

Severity of Airway Interruption [Assessment made by surgeon during minimally invasive parathyroidectomy surgery]
Quality of Operative Field [Assessment made by surgeon during minimally invasive parathyroidectomy surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.