NCT02479789

Brief Summary

Intra operative Nerve Monitoring ( IONM ) is rapidly becoming the standard of care for thyroid surgery to prevent injury to the recurrent laryngeal nerve. However the laryngo tracheal reflexes need to be adequately suppressed to permit proper utilization of intra operative nerve monitoring. Increasing the depth of anesthesia to achieve this often leads to side effects. Intravenous lidocaine infusion has been shown to be effective in blunting these reflexes. The planned study intends to look at the efficacy of intravenous lidocaine infusion in decreasing the amount of anesthesia medications needed to suppress the reflexes. Also the study looks at the analgesic and anti emetic properties of intravenous lidocaine infusion post operatively by measuring these outcomes. The study is designed as a double blinded randomized controlled trial with 30 subjects in the group who will receive intravenous lidocaine during surgery and 30 subjects in the group who will receive placebo. Blunting of the laryngo tracheal reflexes intra operatively will be recorded as the primary outcome. The amount of anesthesia medications, the post operative patient comfort level, pain control, usage of narcotic pain medications, nausea, vomiting will be recorded as secondary outcomes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

3.1 years

First QC Date

June 21, 2015

Last Update Submit

February 19, 2018

Conditions

ThyroidectomyNerve Monitoring

Keywords

Intravenous LidocaineRecurrent laryngeal nerveIntra operative nerve monitoringThyroidectomy

Outcome Measures

Primary Outcomes (1)

  • Suppression of laryngo tracheal reflexes during thyroid surgery

    Number of times laryngo tracheal reflexes were encountered during surgery will be recorded.

    From beginning of surgery to the end of surgery

Secondary Outcomes (5)

  • Amount of Anesthesia medications used

    From beginning of surgery to the end of surgery

  • Post operative pain control

    At 30 minutes, two hours, eight hours, 24 hours after surgery

  • Post operative usage of medications to control pain

    Within 24 hours of surgery

  • Post operative nausea

    At 30 minutes, two hours, eight hours, 24 hours after surgery

  • Post operative overall patient comfort as measure of the anti inflammatory effect of Lidocaine

    At 30 minutes, two hours, eight hours, 24 hours after surgery

Study Arms (2)

Lidocaine

EXPERIMENTAL

Subjects in the Lidocaine arm of the randomized trial will receive a bolus of 1 mg /Kg of IV lidocaine followed by 1.5 mg/KG/h of IV lidocaine infusion during the surgery which will be stopped at extubation.

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

Subjects in the Placebo arm of the randomized trial will receive a bolus of 1mg/kg Placebo ( 0.9% saline) followed by 1.5 mg/KG/h Placebo ( 0.9% saline) infusion during the surgery which will be stopped at extubation.

Drug: Placebo

Interventions

LidocaineDRUG
Also known as: Xylocaine, Lignocaine
Lidocaine
PlaceboDRUG
Also known as: Normal Saline
Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consenting patients undergoing bilateral thyroid surgery
  • Age- 18-85 y

You may not qualify if:

  • Patients undergoing additional procedures,
  • Patients younger than 18y or older than 85 years.
  • Patients at high risk for use of lidocaine due to Congestive heart failure, arrhythmia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health and Wellness Center- Bronx Lebanon Hospital Center

The Bronx, New York, 10457, United States

Location

Related Publications (1)

  • Govindarajan R, Shah A, Reddy VS, Parithivel V, Ravikumar S, Livingstone D. Improving the functionality of intra-operative nerve monitoring during thyroid surgery: is lidocaine an option? J Clin Med Res. 2015 Apr;7(4):282-5. doi: 10.14740/jocmr2025w. Epub 2015 Feb 9.

    PMID: 25699129RESULT

MeSH Terms

Interventions

LidocaineSaline Solution

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ramasamy Govindarajan, MD

    Bronx Lebanon Hospital Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research In-Charge, Anesthesia

Study Record Dates

First Submitted

June 21, 2015

First Posted

June 24, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

US(1)