Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ronald Emerson
ORCID ID
http://orcid.org/0000-0002-8592-7539
Contact details
Hospital for Special Surgery
535 East 70th Street
New York
10021
United States of America
+1 212 774 2742
emersonr@hss.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12005
Study information
Scientific title
In 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?
Acronym
Study hypothesis
There 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
Institutional Review Board, Hospital for Special Surgery., 28/03/2012, ref: 12005
Study design
Single-centre randomised cross over trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Multilevel posterior spinal fusion
Intervention
Each 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 type
Drug
Phase
Drug names
Lidocaine
Primary outcome measure
1. 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 measures
1. 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 trial start date
15/08/2011
Overall trial end date
16/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. 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
Recruitment start date
28/03/2012
Recruitment end date
05/03/2014
Locations
Countries of recruitment
United States of America
Trial participating centre
Hospital for Special Surgery
535 East 70th Street
New York
10021
United States of America
Sponsor information
Organisation
Hospital for Special Surgery
Sponsor details
535 East 70 Street
New York
10021
United States of America
+1 212 774 2742
emersonr@hss.edu
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Hospital for Special Surgery
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication of study results in a peer reviewed journal.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Ronald Emerson (emersonr@hss.edu)
Intention to publish date
02/01/2017
Participant level data
Available on request
Basic results (scientific)
Publication list