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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Withdrawn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
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    September 11, 2007
    Last Updated
    December 5, 2012
    Sponsor
    M.D. Anderson Cancer Center
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    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    Withdrawn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

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