NCT00528502

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2006

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

December 7, 2012

Status Verified

December 1, 2012

Enrollment Period

1.6 years

First QC Date

September 11, 2007

Last Update Submit

December 5, 2012

Conditions

Parathyroid Disease

Keywords

Parathyroid DiseaseMinimal Invasive Parathyroid SurgeryMIPSLaryngeal ReflexesLidocaineSaline

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Saline

EXPERIMENTAL

Saline misted into the air breathe during the surgery.

Drug: Saline

Lidocaine

EXPERIMENTAL

Lidocaine misted into the air during the surgery.

Drug: Lidocaine

Interventions

LidocaineDRUG

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

Lidocaine
SalineDRUG

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

Saline

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All outpatients scheduled for MIPS at the ACB by Dr N Perrier, Dr D Evans and Dr JE Lee.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Parathyroid Diseases

Interventions

LidocaineSodium Chloride

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Spencer Kee, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2007

First Posted

September 12, 2007

Study Start

June 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

December 7, 2012

Record last verified: 2012-12