Lidocaine Supplement for Minimal Invasive Parathyroid Surgery
Primary Purpose
Parathyroid Disease
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lidocaine
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Parathyroid Disease focused on measuring Parathyroid Disease, Minimal Invasive Parathyroid Surgery, MIPS, Laryngeal Reflexes, Lidocaine, Saline
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Saline
Lidocaine
Arm Description
Saline misted into the air breathe during the surgery.
Lidocaine misted into the air during the surgery.
Outcomes
Primary Outcome Measures
Severity of Airway Interruption
Quality of Operative Field
Secondary Outcome Measures
Full Information
NCT ID
NCT00528502
First Posted
September 11, 2007
Last Updated
December 5, 2012
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00528502
Brief Title
Lidocaine Supplement for Minimal Invasive Parathyroid Surgery
Official Title
Prevention of Laryngeal Reflexes in Minimal Invasive Parathyroid Surgery by the Use of Topical Lidocaine
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Terminated due to no patient enrollment.
Study Start Date
June 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parathyroid Disease
Keywords
Parathyroid Disease, Minimal Invasive Parathyroid Surgery, MIPS, Laryngeal Reflexes, Lidocaine, Saline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline
Arm Type
Experimental
Arm Description
Saline misted into the air breathe during the surgery.
Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
Lidocaine misted into the air during the surgery.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Lidocaine is misted into the air that you breathe during the surgery.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Saline is misted into the air that you breathe during the surgery.
Primary Outcome Measure Information:
Title
Severity of Airway Interruption
Time Frame
Assessment made by surgeon during minimally invasive parathyroidectomy surgery
Title
Quality of Operative Field
Time Frame
Assessment made by surgeon during minimally invasive parathyroidectomy surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Spencer Kee, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center official web site
Learn more about this trial
Lidocaine Supplement for Minimal Invasive Parathyroid Surgery
We'll reach out to this number within 24 hrs