Thyroidectomy Clinical Trial
Official title:
Efficacy of Intravenous Lidocaine in the Operative Management of Thyroid Surgery With Intraoperative Nerve Monitoring
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.
Intra Operative Nerve Monitoring ( IONM) is rapidly becoming a standard of care in many
institutions across the country. While the overall incidence of nerve palsy is low, when it
occurs it is a devastating lifelong handicap . Several studies have documented that routine
identification of the RLN with IONM has decreased the rates of permanent RLN palsy It is not
designed to visualize the recurrent laryngeal nerve (RLN), but to allow intra-operative
assessment of RLN function as well as to establish a prognosis in patients developing RLN
paralysis. Complete functionality of the IONM depends on near total laryngeal relaxation and
reflex suppression without the use of neuromuscular blocking agents (NMBAs). The depth of
anesthesia required to meet that criteria often leads to hemodynamic instability.
When the IONM signal is unchanged after the resection, the surgeon can be reassured that
postoperative vocal cord function is normal in 99.6% of cases. Where the IONM signal is
absent or abnormal, 30-45% of the patients will develop vocal cord dysfunction
postoperatively The successful deployment and data analysis from the IONM depends upon the
complete laryngeal relaxation and reflex suppression. The IONM causes strong contractions of
the vocal cords and is an independent cause of laryngeal alterations . The surgical procedure
is a strong factor of stress to the larynx with a potentially traumatic manipulation at the
level of the larynx . Complete functionality of the IONM constitutes before the full
electromyographic recovery of the NMB at the adductor pollicis muscle , as the laryngeal
muscles recover faster than the peripheral muscles . The anesthetic technique chosen should
ensure absolute laryngeal reflex suppression as the effect of the short acting depolarizing
muscle relaxant is wearing off immediately following intubation, until preferably the
extubation. Be it total intravenous anesthesia or inhalation-based anesthesia, the depth
required for reflex suppression can cause profound cardiovascular instability. While the
attempts to titrate down the anesthetic depth can cause resurfacing of the troublesome
laryngeal reflexes, attempts to counter the side effects with sympathomimetic agents can
themselves result in a myriad of undesirable hemodynamic consequences. The resulting
hemodynamic fluctuations can result in adverse outcomes in patients with significant
cardiovascular co-morbidities.
Laryngoscopy with or without intubation, provokes a sympathoadrenal response. These events
are especially detrimental in individuals who have limited myocardial reserve because of age
or disease; these include geriatric population and those with significant coronary
arteriosclerosis as in diabetes mellitus, sustained hypertension, angina, ischemic heart
disease and cardiac dysrhythmias . IV lidocaine decreases the intracellular Ca2+
concentration in airway smooth muscle, decreases myofilament Ca2+ sensitivity and has been
shown to suppress coughing and prevent reflex broncho constriction. Injected intravenously,
lidocaine is variably effective in blunting the hemodynamic response to tracheal intubation .
IV lidocaine has analgesic, anti-hyperalgesic and anti-inflammatory properties. Local
anesthetics can reduce the postoperative inflammatory response in several ways such as
blocking neural transmission at the site of tissue injury and thus attenuating neurogenic
inflammation. In addition because of anti-inflammatory properties of their own, they may
inhibit the migration of granulocytes and release of lysosomal enzymes, consequently leading
to a decreased release of pro-inflammatory cytokines. Pro-inflammatory cytokines can induce
peripheral and central sensitization, leading to pain augmentation (hyperalgesia)
Because of its plasma half life of 8 min, an IV bolus of 1 - 1.5 mg/kg lidocaine must be
followed by infusion of 1 - 4 mg/min in adults in order to maintain therapeutic levels of 1.5
- 4 μg/mL (15, 16). Lidocaine side effects have never been reported in its intended use,
probably because the first clinical signs of toxicity occur at considerably high blood
concentrations (> 5 μg/mL), which did not occur even when IV lidocaine was given continuously
over 14 days . Lidocaine infusion at the rate of 1.5 mg/kg/h following a bolus of 1.5 mg/kg
has been employed in a newborn to perform an intra-operative wake-up test during neurosurgery
. It was also used during thyroidectomy in 60 y old patient with cardiac co morbidities This
will be a prospective double blinded randomized controlled trial done at Bronx Lebanon
Hospital Center. 60 consecutive patients undergoing thyroidectomy using nerve monitoring will
be randomized into two groups of thirty each. One group will receive IV Lidocaine infusion
during the surgery to facilitate the nerve monitoring. The other group will receive a
placebo.
Patient recruitment:
The nurse administrator in the General Surgery clinic will talk to all patients coming to the
clinic for thyroid surgery and will inform them about the study. A booklet explaining the
nature of the study, risks and benefits will be provided to the patients by the
administrator. Patients who are willing to participate in the study will be asked to convey
the same with the surgeon.
After this the patients will be sent for pre operative medical evaluation and testing. Based
on the history, physical examination, investigations and medical evaluation, they will be
included or excluded from the study.
Informed consent will then be taken from the patients willing to participate in the study and
those who meet the inclusion criteria. This consent will be separate from the surgical
consent.
The day of surgery:
The patient will come to ambulatory surgery after overnight fasting. Vitals will be checked
and the patient is seen by the anesthesiologist and surgeon in the ambulatory surgery unit.
There after the patient is wheeled into the operating room for surgery.
Two days prior to the surgery, pharmacy will be notified of the case. The research pharmacist
will prepare the lidocaine or placebo vial according to the randomization chart. This will be
picked up and given to the anesthesiologist.
In the operating room:
The surgery is done in supine position with the head extended using a shoulder roll. Propofol
and Fentanyl are used for induction. Neuro muscular blockade which is routinely used in other
surgeries will not be used in this surgery.
Dragonfly Single Channel Laryngeal Surface Electrode (Electrode LSE 500Ms; Neurovision
Medical Products,Ventura, CA, USA) will be applied to a #7 cuffed ETT (Medline Industries,
Mundelein, Illinois, USA) according to the manufacturer's instructions. The patient will be
pre-oxygenated and then induced with a bolus of midazolam 2 mg and fentanyl 1.25 μg/kg
followed by etomidate 0.25 mg/kg and succinylcholine 1.2 mg/kg intravenously. Direct
laryngoscopy is done and endotracheal intubation is done. The nerve monitoring apparatus is
set up and the placement of the electrode plates touching the vocal cords will be verified
under vision with a Glidescope®, after positioning the patient with the desired neck
extension or by impedence measurement. The patient will be cleaned and draped.The patients
will receive a bolus of 1 mg /Kg of IV lidocaine/Placebo ( 0.9% saline) followed by 1.5
mg/KG/h of IV lidocaine/Placebo ( 0.9% saline) infusion during the surgery which will be
stopped at extubation.
Esmolol in titrated boluses will be used to blunt the sympatho adrenal responses during the
intubation. Anesthesia will be maintained with 50:50 mixture of air in oxygen and 1 - 2
minimum alveolar concentration of sevoflurane. IV infusion of propofol 50 μg/ kg/min will be
titrated to effect for maintenance. Intra operative nerve monitoring ( IONM) will be used to
identify the recurrenct laryngeal nerves. Dragonfly Single Channel Laryngeal Surface
Electrode [Neurovision Medical Products, Ventura, CA; Electrode LSE 500Ms] will be used as
part of the electromyography circuit to facilitate the neve monitoring. A Bispectral Index
(BIS) monitor (Aspect Medical Systems, Newton, MA; Model 1 A 2000) will be used to guard
against "recall" during lighter planes of anesthesia and a train of four (TOF) monitor [
Microstim Plus, Neurotechnology, Houston, Texas, USA ] will be employed to guard against
inadvertent neuromuscular blockade.
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. The intended period of the study will be one year. 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.
;
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