TITLE

ORAL PREMEDICATION WITH

PREGABALIN OR CLONIDINE FOR
HAEMODYNAMIC STABILITY
DURING LARYNGOSCOPY AND
INTUBATION
 Introduction
• Direct laryngoscopy and Intubation predictably leads to tachycardia and
hypertension, which are usually transient, variable and unpredictable.
Usually, these changes are well tolerated by healthy patients but may be
fatal in patients with hypertension and coronary artery disease. Many
pharmacological methods were evaluated either in premedication or during
induction to attenuate the adverse hemodynamic response to laryngoscopy
and Intubation, such as deepening the anesthesia, pretreatment with
vasodilators, adrenoreceptor blockers, calcium channel blockers, and
opioids, with variable results. The present study was designed as blind
randomized controlled study to evaluate, compare the efficacy of ORAL
premedication with pregabalin or clonidine on sedation, anxiety and
changes in HR and NABP during laryngoscopy & Intubation along with
perioperative haemodynamic stability.
• Pregabalin

• Pregabalin is a gabapentinoid compound, is described structurally

as (s0-3 amino methyl-5-methylhexanoic acid. Prgabalin is
structurally related to the inhibitory neurotransmitter gamma amino
butyric acid (GABA), but is not functionally related to it. It acts by
decreasing the synthesis of the neurotransmitter glutamate to act on
the central nervous ststem, and possesses analgesic,
anticonvulsant and anxiolytic activity and is effective in preventing
neuropathic component of acute nociceptive pain of surgery. It is
well-absorbed and tolerated after oral administration, with peak
plasma concentration achieved within 1 hr. It undergoes negligible
hepatic metabolism.
• Clonidine

• Clonidine activates the (alpha)2 adrenergic receptors in th brain and

spinal cord to decrease sympathetic outflow, causing sedation,
analgesia, hypotension and bradycardia without significant
respiratory depression. It is well-absorbed after oral administration
with peak plasma concentration in 75-90 mins. The perioperative
use decreases the intraoperative stress response by reducing
nociceptive transmission and decrease Norepinephrine
concentration in serum, providing hemodynamic stablility.
 AIMS AND OBJECTIVES

1. To assess the efficacy and compare oral pregabalin and oral

clonidine premedication for the attenuation of hemodynamic
responses like heart rate (HR), BLOOD PRESSURE (BP) and rate
pressure product (RPP) = systolic blood pressure x heart rate)
following laryngoscopy and tracheal intubation.

2. To assess any side effects like hypotension, bradycardia, and

sedation associated with these drugs
 MATERIALS AND METHODS
• Study area:
• The study will be conducted in the Department of anaesthesiology, CARE
Hospitals, Banjara Hills, Hyderabad.
• Study Population:
• All patients posted for elective surgical procedures under GA of age group
18 to 60 years of either sex and those belonging to American society of
the anesthesiologists physical status 1 & 2 will constitute the study
population.
• Sample Size:
• A total of 100 patients will be evaluated.
• Study Design:
• A prospective, randomized controlled double blinded comparative study
will be done. The co-investigator will be the basis for sample size
calculation in view of paucity of literature in aesthetic practice.
• Study duration:
• The proposed study will be conducted over a period of 1 year
• Data collection methods:

• Written informed consent of the subjects or responsible attendant

will be obtained.

• Statistical methods:
• Continuous / quantitative analysis will be stated as Mean ± SD
(Standard Deviation) and range. P values will be calculated to assess
the significance in the difference in the mean values obtained in the
study. SPSS package will be used for statistical analysis using chi-
square test where relavant. Significance will be assessed at 5 %
level of significance i.e. if P values were < 0.05, the findings or the
difference in the findings will be considered significant.

• Ethical consideration:
• The study protocol will be subjected to clearance and approval from
the Institutional ethics Committee.
• EQUIPMENT
• Mackintosh blade with handle
• Endotracheal tube
• ECG Monitor
• Pulse oximeter
• Non invasive blood pressure
• Nerve stimulator
• Observer anesthetist
• Ventilator
• ETCO2
Inclusion criteria
1. Age group 18-60,of either sex, scheduled for elective procedures.
2. American Society of Anesthesiologists physical status 1-2
3. Patients willing for study
Exclusion criteria
1. Uncontrolled Hypertension, DM
2. Coronary artery diseases, renal, hepatic or cerebral insufficiency
3. Asthma
4. Allergy to drugs used in the study
5. Patients with coagulopathies or receiving drugs influencing blood
coagulation and those contraindicated for controlled hypotension
were also excluded from the study.
6. Other exclusion criteria included anticipated difficult intubation,
patients with morbid obesity, and history of taking antihypertensive,
antidepresents, antianxiety, anti-convulsant or anti-psychotics.
• Group allocation
• After undergoing a thorough pre-anesthetic evaluation with
checking out patients basal laboratory investigations(CBP,RBS,RP)
ECG,CXR,2D ECHO(in selected patients) and then those who are
eligible and who are willing to participate in study will be allocated
to 2 groups after obtaining a written informed consent from them.
Patients will be randomly assigned into two groups by computer-
generated random numbers.

• Group P received – 150 mg pregabalin

• Group C received – 200 µg clonidine

• All patients will be kept fasting overnight after 10 pm and receiving

Tab lorazepam 1 mg and ranitidine Tab150 mg as premedication on
the night before surgery. On the morning of surgery all patients will
be receiving either oral pregabalin or clonidine randomly 60- 90
Minutes before admission to the OT. The observer will be totally
blind about the groups and medication received by the patients
• Methodology

• On arrival in the pre-operative room, monitors will be attached and

baseline parameters like pulse rate, systolic, diastolic, and mean
arterial blood pressure, oxygen saturation and ECG will be recorded.
• The preoperative level of sedation will be assessed by the four point
score described by Chernik et al

• Grade 0 – Patient wide awake.

• Grade 1 – patient is sleeping comfortably but responding to verbal
commands.
• Grade 2 – Deep sleep but arousable.
• Grade 3 – Deep sleep, unarousable.
• Intravenous line will be secured and IV fluids started at 6 to 8 ml per kg
and premedicated with IV ondansetron 4 mg, IV glycopyorolate 0.2 mg,
I V midazolam 1 mg, IV fentanyl 2mcg/kg.
• After pre-oxygenation for 3 mins with 100% oxygen, induction will be
done with IV propofol 2 mg/kg. Direct laryngoscoy and intubation will
be facilitated with IV succinylcholine 2 mg/kg. anaesthesia will be
maintained with O2 + Air + Isoflurane and intermittent muscle relaxant
injection IV vecuronium bromide 0.1 mg/kg (loading dose) and 0.02
mg/kg (maintainance dose) later.
• During laryngoscopy and endotracheial intubation heart rate, systolic,
diastolic blood pressure and mean blood pressure will be recorded at
0, 1, 3, 5, and 10 mins. The patients will be mechanically ventilated to
maintain the normocapnia (ETCO2 between 35 and 40 mm/Hg). After
completion of the surgery residual neuromuscular block will be
reversed with appropriate doses of myopyorolate and extubation will
be performed.
• Patients will be observed for complications like hypotension
bradycardia, hypertension, arrhythmias, hypoxia, bronchospasm and
treated accordingly.
 Observation

SEDATION SCORING
Grade 0 – patient wide awake
Grade 1 – patient sleeping but responds to commands
Grade 2 – deep sleep but arousable
Grade 3 – deep sleep, unarousable