ClinicalTrials.gov
ClinicalTrials.gov Menu

Lidocaine Supplement for Minimal Invasive Parathyroid Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00528502
Recruitment Status : Withdrawn (Terminated due to no patient enrollment.)
First Posted : September 12, 2007
Last Update Posted : December 7, 2012
Sponsor:
Information provided by (Responsible Party):
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.


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 Type : Interventional  (Clinical Trial)
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 : June 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Severity of Airway Interruption [ Time Frame: Assessment made by surgeon during minimally invasive parathyroidectomy surgery ]
  2. Quality of Operative Field [ Time Frame: Assessment made by surgeon during minimally invasive parathyroidectomy surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528502


Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Spencer Kee, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00528502     History of Changes
Other Study ID Numbers: 2006-0147
First Posted: September 12, 2007    Key Record Dates
Last Update Posted: December 7, 2012
Last Verified: December 2012

Keywords provided by M.D. Anderson Cancer Center:
Parathyroid Disease
Minimal Invasive Parathyroid Surgery
MIPS
Laryngeal Reflexes
Lidocaine
Saline

Additional relevant MeSH terms:
Parathyroid Diseases
Endocrine System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action