A double blind, randomised, controlled trial to study the

effect of dexmeditomidine on hemodynamic and

recovery responses during tracheal extubation.
ABSTRACT
This study was done to see the effect of bolus dose of dexmeditomidine on hemodynamic
responses and airway reflexes during extubation. Materials and methods- Sixty patients
aged 20-45 yrs of either sex of ASA grade I/II scheduled for elective general surgical, ENT,
orthopedics and gynecological surgeries were studied after randomisation into two groups.
Group A and B, received an intravenous dexmeditomidine 0.5 mcg/kg or placebo
respectively over 1-2 minutes before anticipated end of surgery, in a double blind manner.
Standard anesthesia techniques were followed, heart rate , systolic, diastolic, mean arterial
pressures were recorded at the start of bolus drug injection and there after 1, 2 and 3
minutes after injection, during extubation, at 1, 3, 5 minutes after extubation and thereafter
every 5 minutes for 15 minutes. Quality of extubation was evaluated based on cough
immediately after extubation using a five point rating scale and postoperative sedation was
evaluated on a six point scale. Side effects like laryngospasm, bronchospasm, respiratory
depression, desaturation, vomiting, hypotention, bradycardia and undue sedation was
noted. Results Heart rate,systolic,diastolic, mean arterial pressure were significantly higher
in group B (P<0.05).Extubation quality score in majority of cases was 1 in study group and 3
in control group. Sedation score in most of the cases was 3 in study group and 2 in control
group. Bradycardia and hypotention were noticed in study group.Vomiting was noticed in 1 in
study group and 3 patients in control group. Conclusion- Our study conclude that single
dose of dexmeditomidine 0.5 mcg/kg administered 5 minutes before extubation attenuates
the hemodynamic and airway reflexes during emergence from anesthesia without causing
undue sedation.
Introduction
Emergence from anesthesia and tracheal extubation are usually associated with
hypertension, tachycardia and high plasma catecholamines leading to increased systemic
vascular resistance and myocardial contractility (1). The peak changes are noticed about
one minute following extubation and continue until 10 minutes. Majority of the patients
tolerate these changes without any significant clinical consequences but patients suffering
from diseases like hypertension, diabetes, CAD etc may not tolerate these responses(2).
Various agents like lidocaine, opioids, esmolol, fentanyl, calcium channel blockers,
magnesium sulphate and pripofol have been shown to attenuate these responses but they
have limitations and side effects (3, 4).
Alpha-2-Adrenergic receptor (AR) agonists have been the focus of interest for their
sedative, analgesic, perioperative sympaholytic anesthetic sparing and hemodynamic
stabilizing properties Dexmeditomidine a highly selective 2 AR agonist possesses all these
properties but lacks repiratory depression making it a useful and safe adjunct in diverse
clinical applications(5). Dexmeditomidine is a new 2 aginist with 8 times more affinity
compared with clonidine
and so suppresses the release of catecholamines to stress

response. This drug may be useful in anesthetic management requiring smooth emergence
from anesthesia. The net effect of Dexmeditomidine action is a significant reduction in
circulating catecholamines with a slight decrease in BP and a modest reduction in HR.
Our study was designed to determine the effects of single bolus dose of
dexmeditomidine as an effective drug to attenuate the hemodynamic response to
emergence from general anaesthesia and tracheal extubation.
Material and methods
This clinical study was carried out on sixty patients (30 in each group) between 20
to 45 years of age of either sex belonging to ASA physical status I and II and scheduled for
elective general surgical, ENT and gynaecological surgery under general anesthesia
patients suffering from cardiovascular, respiratory disorders, diabetes, hypertension, obesity,
difficult airway, history of sleep apnoea, pregnancy, breast feeding women, medications that
affect heart rate or BP and emergency procedures were excluded.
Institutional board approval was taken and written informed consent was taken from
each patient. Preanesthetic check up was conducted and a detailed history and a complete
physical examination recorded. Routine investigations like complete blood picture, blood
grouping and typing,blood urea,serum creatinine, bleeding time clotting time,blood sugar,
ECG and chest radiography were done. Patients were randomly divided in to 2 groups of 30
each. Randomisation was done by computer generated table.
Group A as study group (Dexmeditomidine) and, group B as control group.
Routine anaesthetic technique was used using propofol,fentanyl,vecuronium,nitrous
oxide-oxygen and isoflorane standard monitoring with ECG, pulse oximetry (spo2), Etco2
and non invasive BP were measured. About 5 minutes before the estimated time of end of
surgery, inhalational agent was cut off and patients in each group received the specified
solution intravenously over 1 2 minutes.
Patients in group A received dexmeditomidine 0.5g/kg iv in 10ml saline over 1-2 minutes,
while in Group B patients received 10 ml saline over 1-2 minutes.
HR, SBP, DBP, and MAP were recorded at the start of bolus drug injection and there
after 1, 2, 3 minutes. Residual neuromuscular blockade was reversed with neostigmine and
glycopyrolate given iv when spontaneous respirations were sufficient and able to obey
simple commands, suction of the throat was done and tracheal was extubated.
The anaesthesiologist performing the extubation was double blinded to the study
drugs.HR; SBP, DBP and MAP were recorded at the time of extubation and thereafter 1, 3,
5, 10 and at 15 minutes after extubation. Any side effects like larygospasm , bronchospasm,
respiratory depression, desaturation , vomiting hypotension and bradycadia and undue
sedation was noted.
Hypotension was defined as a decrease in SBP of more than 20% decrease from
base line or SBP less than 80mmHg. Bradycardia was defined as HR of less than 60/ min
and was corrected if assosciated with hemodynamic instability.

Quality of extubation was evaluated based on cough immediately after extubation,

using a 5 point rating scale (6). 1- no coughing; 2- smooth extubation with minimal coughing(
1 or 2 times); 3- moderate coughing(3 or 4 times); 4- severe coughing (5 to 10 times) and
straning; 5- poor extubation , very uncomfortable( laryngospasm and coughing>10 times).
Post operative sedation was evaluated 5 minutes after extubation on a 6 point scale
(Ramsay sedation scale)(7). 1- Anxious or agitated and restless or both; 2- cooperative,
oriented and tranquil, 3- drowsy but responds to commands; 4- asleep, brisk response to
glabellar tap or loud auditory stimulus , 5- Asleep and slow response to stimulation, 6Asleep and unarousable, no response to stimulation.
Power of study was calculated

Results
The patients in the two groups were comparable for age, weight and male:female
ratio, ASA physical status, Mallampati class, nature of surgery and the difference between
the two groups were not statistically significant ( p value ) [ Table 1]
We observed a statistically significant difference (p< 0.05) in HR between the two
groups from 5 minutes after starting administrating of the agent till 15 minutes after
extubation(table 2). A statistically significant difference (p<0.05) was observed in SBP
between the two groups from 5 min after the start of the administration of the agent and
continued till the time observation were made (table 2). Our study showed a significant
difference in DBP between the two groups (p<0.05) from 5min after the starting the
administration of the agent and continued till the time observation were made (table 2). The
Mean ABP between the two groups showed statistically significant difference (p<0.05) from
5min starting the administration of the agent and continued till the time observation were
made (table 2).
We observed
a statistically significant difference (p< 0.05) in the quality of
extubation between the two groups (p<
) [table 3]. 60% of the patients in group A could
be extubated smoothly without any cough; where as 40% of patients showed minimal
coughing at the time of extubation.
67% of patients in GroupB showed moderate coughing at the time of extubation,
whereas only 33% of the patients could be extubated smoothly with minimal coughing [table
3].
A significant difference in the level of postoperative sedation was observed between
the two groups (p
) [table 3]. 90% of the patients in group A were drowsy but
responding to commands with the sedation score of 3 on the Ramsay scale where as in
group B, 93% of patients were cooperative, oriented and tranquil with a sedation score of 2
on the Ramsay scale [table 3].
The incidence of bradycardia and hypotension was higher in group A compared to
Group B[table4]. One patient in Group A developed bradycardia, but none in control group. 2

patients in group A developed hypotension where as none in control group, but none
required treatment for bradycardia or hypotension.
One patient in group A and 3 in groupB had vomiting after extubation. Other side
effects like respiratory depression, laryngospasm , bronchospasm , or undue sedation were
not observed in either of the groups. Also no significant difference was observed between
the two groups in spo2 values.[fig 1]
Discussion
Emergence from general anaesthesia and tracheal extubation are often
accompanied by tachycondia and hypertension and is of equal concern as intubation
response (15). These responses may produce myocardial ischemia or infarction in
susceptible patients. Alpha-2 Adrengicreceptior agonists decrease the sympathetic outflows
and noradrenergic activity, thereby counteracting hemodynamic fluctuations occurring at the
time of intubation (5).
Dexmeditomidine is a new 2 against, suppresses the release of catecholamines to
stress response. The present study was conducted to evaluate the effect of
dexmeditomidine in a dose of 0.5 mg/kg(as a single bolus dose) on hemodynamic response
during extubation, the quality of extubation, the level of post operative sedition and the
prevalence of complications. We found that the cough reflex, increase in systolic and
diastolic arterial pressure, heart rate associated with emergence from anaesthesia were
attenuated by single bolus dose of dexmedito midine 0.5mg/kg.
In our study one patient (3.3%) had bradycardia in study group (Group A) which
was not required any treatment. This is in conjunction with the observation by Aksu et al
(10).
In our study, in the study group we observed that HR did not show a significant rise
compared to basal value from second minute of drug administration, at extubation and any
period post extubation. But in control group there was a significant rise in HR compared to
basal value. This observation is in concurrence with the study done by Shirang Rao et al (2).
SBP, DBP, MAP values are significantly lower in study group compared to base line
values at all times from the time of injection of dexmeditomedine to post extubation for 15
minutes. This is in conjunction with the study conducted by Bindu et al (9).
The incidence of bradycardia and hypotension was higher in study group (Group A)
compared to control group (Group B). One patient in Group A developed bradycardia but
none in Group B, Two patients in Group - A developed hypotension but none in Group B.
None of the patients required treatment for bradycardia and hypotension. This is in
conjunction with observations by Guler et al (8).
Turan et al found that dexmeditomidine 0.5mg/kg administered 5 mts before the end
of surgery stabilized haemodynamics, allowed easy extubation, provided a more comfortable
recovery and early neurological examination following intracramial operations(6)(contd next
page Turan et al). Turan et al studied the effects of two different doses of dexmeditomidine
during the extubation period in patients operated for intracranial lesions. They concluded that
dexmeditomidine used in a dose of 0.5 mg/kg in 1 mt before extubation is a suitable agent
for optimal haemodynamic state and good recovery condition for intracranial operations.(6).

In our study we observed a significant difference in the quality of extubation between

the study and control groups. 60% of the patients in group A could be extubated smoothly
without any cough where as 33% of the patients could be extubated smoothly with minimal
coughing. This is in conjunction with the observation by Recep Atsu et al.
SPO2 values were comparable in both the groups with no significant difference was
observed in SPO2 values, no incidence of desaturation. No side effects like broncospasm
leigospasm, respiratory depression or undue sedition was noticed in either of the groups.
These observations are in concurrence with study conducted by Guler et al (8).
Sedation in our study was assessed by using Ramsay Sedition Scale. Significant
numbers of patients in study group were drowsy but responded to verbal commands
(Ramsay Sedition Scale 3) when compared to control group, where most patients with a
sedition score of 2 on the ramsay Scale. This is in conjunction with the study conducted by
Bharkha Bindu et al.
Our study found insignificant difference in the incidence of vomiting between two
groups.
To conclude, use of dexmedetomidine before extubation attenuates the
hemodynamic response to extubation. It enables smooth extubation of the trachea and
provides adequate sedition post operatively.

References
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Guler et al, studied the effect of a single bolus dose of dexmeditomidine 0.5mg/kg as
a bolus 1/v over 60 seconds in patients undergoing intraocular surgery. The authors findings
suggested that a single bolus dose of dexomeditomidine before tracheal extubation
attenuated airway-circulatory reflexes during extubation without affecting emergence time,
an effect possibly medicated via its sedative and analgesic properties,(7). In the same study
one patient had bradycardia and three had hypotensionwas observed) which is noticed
similar results in our study.
Barkha, Bindu et al studied the effect of dexmeditomidinic 0.7mg/kg administered
over 15 minutes before extubation. They concluded that use of dexmeditomidine before
extubation attenuates the homodynamic response to extubation, enable smooth extubation
of the trachea, provides adequate sedition post operatively. Incidence of bradycardia and
hypertension was more with the 0.75mg/kg i/c dose, but does not cause side effects like
respiratory depression, laryngospasm, bronchospasm, undue sedation and debaturation(9).
Dexmeditomidine 0.5mg/kg given 5 minutes before extubation has been found to be
more effective then fantamyl/mg/kg in attenuating airway reflex respose to tracheal
extubation and maintaining hemodynamic stability without prolonging recovery(8).
In our study in the study group we observed that HR did not show a significant rise
compared to basal value from second mode of drug administration, at extubation and any
period post extubation. But in control group, there was a significant rise in HR compared to
basal value.
This observation is in consonance with the study done by Shirang Rao et al(4) where
the pulse rate in study group remained below the pre dose values(base line value) at all
time intervals following extubation.
The incidence of bradycardia and hypotension was higher in study group (Group A)
compared to control group (Group B). One patient in group A developed bradycardia but
none in group B, two patients in group A developed hypotension, where as none of the
patients in group B had hypotension, but none required treatment for bradycardia and
hypotension. This is in conjunction with the observation by Bharkha Bindu et al (9). Systolic
blood pressure, Diastolic blood pressure mean arterial pressure values were significantly
lower in study group compared to base line values at all times from the time of
dexmeditomine injection to post extubation 15mts. This is in conjunction with the observation
by G Guler et al (7).

A double blind, randomised, controlled trial to study the

effect of dexmedetomidine on haemodynamic and
recovery responses during tracheal extubation.
ABSTRACT
Background. To study the effect of bolus dose of dexmedetomidine on
hemodynamic responses and airway reflexes during extubation.
Materials and Methods.
After obtaining institutional ethical committee approval and informed written consent,
sixty American Society of Anaesthesiologists grade I and II patients aged 20 to 45 years of
either sex scheduled for elective general surgical, ENT and Gynaecological Surgeries were
studied. Using computer generated random allocation; patients are divided into two groups,
Group A and B of thirty patients in each group. About 5 minutes before the estimated time of
end of surgery, inhalation agents was cut off and Group A and Group B received an
intravenous bolus dose of dexmeditomidine 0.5 g / kg or placebo respectively over 1-2
minutes in a double blind manner. Anesthesia techniques were standardised. HR , Systolic ,
Diastolic and Mean arterial BP were recorded at the start of bolus drug injection and
thereafter at 1, 2 and 3 minutes after injection, during extubation at 1, 3, 5 minutes after
extubation and there after every 5 minutes for 15 minutes.
Quality of extubation was evaluated based on cough immediately after extubation
using a five point rating scale and post operative sedation was evaluated on a 6 point scale.
Side effects like larygospasm , bronchospasm, respiratory depression, desaturation ,
vomiting hypotension and bradycadia and undue sedation was noted.
Results
HR, SBP, DBP, MAP, were significantly higher in control group (p<
). Extubation
quality score in majority of cases was 1 in study Group and 3 in control Group... sadation
score in most of the cases was 3 in study Group and 2 in control Group. Bradycardia and
Hypotension were noticed in study group. Vomiting was noticed in 1 in studyGroup and 3
patients in control group. No other side effects were noticed in either group.
Conclusion
We conclude that single bolus dose of dexmeditomidine 0.5 mg/kg administered 5
minutes before extubation attenuates the hemodynamic and airway reflexes during
emergence from anesthesia without causing undue sedation.