Effects of intravenous lidocaine on somatosensory and motor evoked potentials during spine surgery

ISRCTN ISRCTN11684890
DOI https://doi.org/10.1186/ISRCTN11684890
Secondary identifying numbers 12005
Submission date
05/01/2017
Registration date
13/01/2017
Last edited
13/01/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Spinal fusion surgery is a type of surgical procedure which joins two or more vertebrae (small bones that make up the spine) together. Multilevel spinal fusion surgery is where this takes place in multiple areas of the spine, and is used for treating serious spinal problems such as spinal deformity such as scoliosis (abnormal twisting of the spine). Somatosensory evoked potentials (SSEPs) and motor evoked potentials (MEPs) are electrical signals in the body, which are commonly monitored during surgical procedures that place the spinal cord at risk. Many general anesthetic agents (drugs used to sedate people for surgery) can affect SSEPs and MEPs in ways that can make them difficult to monitor however. Propofol (an anesthetic) has been shown to better preserve SSEPs and MEPs than many other anesthetic agents, and for this reason, it is commonly used for cases requiring MEP and SSEP monitoring, either on its own or with a low dose of an inhaled agent. Intravenous (through a vein) lidocaine (a numbing agent) has recently been shown to reduce the required propofol dose during surgery, possibly due to pain blocking properties. This is beneficial as it can decrease a patient’s risk of complications associated with high doses of propofol. In this study, patients each receive two anesthetic treatment administered in randomized order, one including a higher dose propofol, and the other including lidocaine plus lower dose of propofol. The aim of this study is to find out whether lidocaine can be added to anesthetic management to allow reduction in propofol requirements without affecting SSEPs or MEPs.

Who can participate?
Adults undergoing multilevel spinal fusion surgery.

What does the study involve?
Each study patient alternately receives two anesthetic treatments in a random order. One treatment involves a high dose of propofol and the other treatment involves a lower dose of propofol with lidocaine. In both treatments, the anesthesia is maintained using a range of drugs usually used in anesthesia. Each treatment lasts for a total of two hours. While the treatment is being given and then at regular intervals throughout surgery, participants have their SSEP and MEP measured using a special monitoring system that measures electrical conductivity in the body.

What are the possible benefits and risks of participating?
There are no direct benefits or risks for patients taking part in the study.

Where is the study run from?
Hospital for Special Surgery (USA)

When is the study starting and how long is it expected to run for?
August 2011 to December 2015

Who is funding the study?
Hospital for Special Surgery (USA)

Who is the main contact?
Dr Ronald Emerson
emersonr@hss.edu

Contact information

Dr Ronald Emerson
Scientific

Hospital for Special Surgery
535 East 70th Street
New York
10021
United States of America

ORCiD logoORCID ID 0000-0002-8592-7539
Phone +1 212 774 2742
Email emersonr@hss.edu

Study information

Study designSingle-centre randomised cross over trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet No participant information sheet available
Scientific titleIn patients undergoing multilevel posterior spinal fusion, does the addition of intravenous lidocaine as a component of balanced anesthesia, compared to balanced anesthesia without lidocaine, alter somatosensory and motor evoked potentials?
Study objectivesThere will be no differences between tibial nerve cortical somatosensory evoked potential (SSEP) amplitudes and motor evoked potential (MEP) threshold voltages under balanced anesthetic conditions including propofol 50 mcg/kg/hr and lidocaine 1 mg/kg/hr plus propofol 25 mcg/kg/hr.
Ethics approval(s)Institutional Review Board, Hospital for Special Surgery., 28/03/2012, ref: 12005
Health condition(s) or problem(s) studiedMultilevel posterior spinal fusion
InterventionEach study patient alternately receives two anesthetic treatments. The order of administration is determined randomly. The treatments are propofol at 50 mcg/kg/h, or propofol 25 mcg/kg/min + lidocaine 1 mg/kg/h. During both treatments, maintenance anesthesia also includes fentanyl 1mcg/kg/h, ketamine 2 mcg/kg/min and diazepam 10mg. Patients additionally receive isoflurane, typically 0.5%, adjusted as needed by the attending anesthesiologist to maintain steady hemodynamics.

The total duration of each treatment is 120 minutes, and each treatment is administered for 30 minutes prior to logging IONM data for this study. Prior to the institution of the lidocaine infusion, each patient receives a loading dose at 1mg/kg over 10 minutes. Primary outcome measurements (SSEP amplitude and MEP threshold voltages) are made by a neurophysiological technologist who is blind to the treatment being administered.
Intervention typeDrug
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)Lidocaine
Primary outcome measure1. Somatosensory evoked potential amplitude is measured using a Cadwell Elite intraoperative monitoring system, at 3-5 minute intervals
2. Motor evoked potentials threshold voltage is measured using a Cadwell Elite intraoperative monitoring system, at 10-20 minute intervals
Secondary outcome measures1. Isoflurane concentration is measured using a General Electric Datex Ohmeda operating room patient monitor at 5 minute intervals
2. Heart rate is measured using a General Electric Datex Ohmeda operating room patient monitor at 5 minute intervals
3. Blood pressure is measured using a General Electric Datex Ohmeda operating room patient monitor at 5 minute intervals
4. Temperature is measured using a General Electric Datex Ohmeda operating room patient monitor at 5 minute intervals
5. Estimated blood loss is measured at the conclusion of the procedure based on cell salvage system data, irrigation and intraoperative blood administration
Overall study start date15/08/2011
Completion date16/12/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Key inclusion criteria1. Patients undergoing multi-level posterior spine fusions requiring both somatosensory and motor evoked potential monitoring
2. Ages within the age range of 18 – 70 years.
Key exclusion criteria1. Allergy to any of the anesthetic medications included in the protocol
2. Current use of medication for Parkinson’s disease
3. Current psychotropic medication
4. History of cardiac arrhythmias
5. Non-English speaking
Date of first enrolment28/03/2012
Date of final enrolment05/03/2014

Locations

Countries of recruitment

  • United States of America

Study participating centre

Hospital for Special Surgery
535 East 70th Street
New York
10021
United States of America

Sponsor information

Hospital for Special Surgery
Hospital/treatment centre

535 East 70 Street
New York
10021
United States of America

Phone +1 212 774 2742
Email emersonr@hss.edu
ROR logo "ROR" https://ror.org/03zjqec80

Funders

Funder type

Hospital/treatment centre

Hospital for Special Surgery

No information available

Results and Publications

Intention to publish date02/01/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication of study results in a peer reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Ronald Emerson (emersonr@hss.edu)