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SRM University Journal of Dental Sciences
Original Research
Efficacy of Propofol and Midazolam in conscious sedation in
minor oral surgery A comparative study
A Gnanam, J Jasline David, Balaji Srikanth, D Siddharth
Department of Oral and Maxillofacial Surgery, SRM Dental college, Ramapuram, Chennai
Address for correspondence:
Dr J Jasline David MDS,
Senior Lecturer,
Department of Oral and Maxillofacial Surgery
SRM Dental College,
Ramapuram, Chennai 600 089.
Email: drjasdavid@yahoo.co.in
Introduction
In day to day Oral and Maxillofacial surgical outpatient
procedures, the fear psychosis is unimaginable due to anxiety
towards surgery and local anaesthetic administration. There
will be considerable burden on time and expenditure on
general anaesthesia which will increase morbidity and
distress. Propofol has several advantages when used in the
outpatient set up and can be used with bolus technique
familiar to most oral surgeons administrated through an
infusion pump1. It has a rapid onset and short duration of
action. This leads to rapid recovery with earlier cognitive and
psychomotor function.
Propofol goes through hepatic metabolism and renal
excretion where up to 90% is excreted in the urine and less
than 1% is excreted unchanged in the faeces2. The sedation at
chair side eliminates the necessity for general anaesthesia and
also save time and energy. The patient can get it done without
observing standard protocols like prolonged starvation, pre
medications etc.
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Volume 2, Issue 2, April - June 2011
Abstract
A procedure which calms the patient with good control on
psychomotor response will help the surgeon to perform surgery
with perfection. One such procedure is the chair side sedation
using midazolam (or) propofol to achieve the desired results.
Though local anesthesia alone is used to provide analgesia for
definitive surgical treatment, it has little effect on patient's fear
and anxiety when compared to sedation allied with local
anesthesia. Midazolam is a fast acting, water soluble
benzodiazepine derivative which has sedative, anxiolytic and
amnesic properties and short duration. Propofol which is 2,6 di-
isopropylphenol is a general anesthetic agent that is delivered
intravenously. It is prepared as 1% (10mg/ml) emulsion in an
aqueous solution of 10% soyabean oil, 2.25%glycerol and
1.25% purified egg phosphatide. It acts by enhancing the
GABA-activated chloride ion channel function. The objective
of this study was to compare propofol and midazolam in terms
of anxiolysis achieved.
Keywords: Conscious sedation, propofol, midazolam
Aim of the study
This study was to compare the efficacy of propofol and
midazolam as conscious sedatives in minor oral surgery and
also it evaluates the depth of analgesia, amnesia, anxiolysis,
and patient's comfort. This study also aims in calculating the
drug dosage, patient's cooperation, drug response, and its
post surgical sequelae.
Materials and methods
The study was conducted in the department of Oral and
Maxillofacial Surgery, SRM dental college with 40 patients,
who required elective removal of impacted teeth with ASA I
(American society of anaesthesiology) health status
representating both sexes, aged between 18years and 40
years, with body weight ranging from 50- 70 kgs. All the
patients were explained elaborately about the procedure and
also the possible intra and post operative complications.
They were thoroughly checked for any existing illnesses and
any associated family history of diabetes or hypertension.
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Efficacy of Propofol and Midazolam in conscious sedation in minor oral surgery A comparative study
Patients were advised to avoid driving for about 6hrs after the
procedure. Separate formats were prepared for general case
history and intraoperative as well as postoperative
recordings. Post operatively the pain response, swelling, any
discomfort due to the procedure and the amnesia is noted in
the case sheet. All the patients were given antibiotics and
analgesics postoperatively. Patients were reviewed every
48hrs till the day of the suture removal.
Figure 1. Trolley displaying the drugs and other gadgets for
sedation
Drug dosage:
First group of patients are given intravenous propofol at
initial dose of 40mgs (0.75mg/kg) and later intermittent doses
of 20mgs. Second group of patients are given intravenous
midazolam in dilution at initial bolus dose of 3mgs
(0.05mg/kg) and later intermittent doses of 1mg each time.
Figure 2: Propofol Figure 3: Midazolam
Procedure:
Preoperatively, assessment of anxiety using CORAHS dental
anxiety scale was done. On arrival to the operating room,
blood pressure cuff, pulse oximeter and ECG monitor were
connected to the patient. Sterile intravenous line was
Streamdent, 2(2), 2011
A Gnanam et al
achieved with 20 gauge cannula. The data such as heart rate,
blood pressure, oxygen saturation, respiratory rate were
recorded 2 minutes before sedation when the patient is lying
quietly and breathing spontaneously. The parameters were
assessed after the onset of sedation, 2 minutes after LA
administration and followed by every 10 minutes interval of
time i.e.10th, 20th, 30th and 40th minute and before
discharging the patient. We used the modified observers
assessment alertness / sedation score (OAA/S) to assess
sedation depth. Time of onset is defined as the time from the
first dose of medication to the time of sedation and score of
3(responds only after name is called or after repeated call).
Time recovery is defined as the time from that an OAA/S
score of 5 (respond readily to name spoken in normal tone).
Amnesia was assessed with two different pictures of easily
recognizable object shown to the patients before the incision
and 10 min after sedation. At the end of operation inability to
recollect any of the objects or the local anesthetic injection
was considered as amnesia. Any post operative
complications like nausea, vomiting, headache, pain at
injection site was recorded. achieved with 20 gauge cannula.
The data such as heart rate, blood pressure, oxygen
saturation, respiratory rate were recorded 2 minutes before
sedation when the patient is lying quietly and breathing
spontaneously. The parameters were assessed after the onset
of sedation, 2minutes after L.A administration and followed
by every 10 minutes interval of time i.e.10th, 20th, 30th and
40th minute and before discharging the patient.
Discussion
Anxiety and fear are inevitable circumstances met by the
patients undergoing oral surgical procedures. Though
tremendous developments have been evolved to alleviate
such unfavorable circumstances, conscious sedation with the
help of local anesthetics to carry out safe and comfortable
minor oral surgical procedures in the outpatient set up has
been accepted as patient friendly method. 40 patients who
required elective removal of impacted mandibular third
molars in the Dept. of Oral and Maxillofacial Surgery, SRM
DENTAL COLLEGE, Ramapuram were included in this trial
study. 20 patients were selected for propofol sedation and
remaining 20 for midazolam sedation. The propofol group
included 9- male and 11-female patients. The midazolam
group included 8-male and 12- female patients. The average
age of the patients ranges from 18-40 years with mean age of
29 years. The body weight of patients ranges from 50-70 kgs
with mean body weight of 59 kgs. Pre-operative assessment
of anxiety by using the CORAH's Dental Anxiety scale was
done on the arrival of the patients to the operating room .In
order to measure the cardio-respiratory baseline data such as
blood pressure, oxygen saturation, respiratory rate etc, the
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Efficacy of Propofol and Midazolam in conscious sedation in minor oral surgery A comparative study
respective gadgets (B.P cuff, Pulse-oximeter, ECG monitor)
were used3. The base line data were recorded 2 minutes
before sedation when the patient was lying quietly and
breathing spontaneously. I.V. line was achieved with 20
gauge cannula and the respective drug was infused. The
parameters were assessed after onset of sedation, followed by
2 minutes after L.A. administration, then 10th, 20th , 30th ,
and 40th minutes till the patient was discharged.
First group received I.V. Propofol at initial bolus dose of 40
mgs (0.75 mg/kg) and later intermittent doses of 20 mgs
whenever required. Second group received I.V. Midazolam at
initial bolus dose of 3 mgs (0.05mg/kg) and later intermittent
doses of 1 mg. The mean total dose of propofol was 61.5 mg
with standard deviation of 9.8mg; whereas midazolam mean
total dose was 4.9mg with standard deviation of 1.1 mg. The
mean duration of surgery was 19 minutes for propofol
patients with standard deviation of 5 minutes, and 21 minutes
for midazolam patients with standard deviation of 5.5
minutes. The parameters taken into consideration were heart
rate, systolic and diastolic blood pressures, respiratory rate,
oxygen saturation, anxiolysis achieved, profoundness of
amnesia, time of onset of drug, time of recovery and other
postoperative complications like nausea, vomiting, headache,
pain at injection as well as in the surgical sites.
In the present study propofol caused decrease in the heart rate
after sedation, and further decrease in the heart rate 2 minutes
after L.A administration, and then slowly increases till 20
minutes, later decreased from 20 to 30 minutes, and gradually
reached to base line value before discharge. Midazolam had
increased heart rate up to 20 minutes after sedation; heart rate
was decreased gradually and comes to base line value before
discharge. On comparison of the effect of propofol and
midazolam in the regular interval of time with respect to
heart rate, propofol decreased the heart rate than midazolam
which was statistically significant, since P value is < 0.05
which is in accordance with above study. In this present study
the systolic blood pressure for propofol decreased up to 2
minutes after LA administration and then slowly increases till
it reaches base line value before discharge. When compared
propofol with midazolam the fall in systolic blood pressure
was not statistically significant, since P- valve is < 0.05. Both
the drugs decreased diastolic blood pressure slowly till 30
minutes after sedation and then slowly increased to base line
value before discharge.
Comparison propofol and midazolam with respects to
diastolic blood pressure in different periods of time showed
no statistically significant difference since P- value < 0.05
with consistent with above study. The ventilatory response to
carbon dioxide and arterial hypoxemia are decreased by
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A Gnanam et al
propofol4,5. Midazolam causes central depression of
respiration. Low sedative doses of midazolam 0.07 mgs/kg
I.V do not affect ventilatory response to Co2.
In this present study respiratory rate was decreased after
propofol and midazolam sedation, midazolam causing more
decreased effect on the respiratory rate than propofol. By
comparing propofol and midazolam with respect to
respiratory rate after sedation, midazolam had decreased
respiratory rate than propofol which is statistically
significant since P- value is < 0.05. The results were in
accordance with Robert K. Stoelting6.
The mean time of onset for propofol was 62 seconds with
standard deviation of 24 seconds, where as for midazolam
was 201 seconds with standard deviation of 72 seconds. The
time of onset was faster in propofol than in midazolam which
is statistically significant with t value - 8.0922 and p- value
0. The time of recovery was defined as the time from last dose
of medication to the time that an OAA/S Score of 5.
According to Pradermchai Kongkam et al the mean recovery
time for propofol was 17.24 minutes with standard deviation
of 5.99 minutes and for midazolam was 34.25 minutes with
standard deviation of 16.06 minutes7.
In the present study we assessed amnesia with two different
pictures of easily recognizable objects shown to the patients
before the incision and 10 minutes after sedation. At the end
of surgery, inability to recall any of the objects or the local
anesthesia injection was assessed as amnesia. The percentage
of patients with amnesia after propofol sedation was 10%,
where as after midazolam sedation was 80%. Therefore
midazolam had more amnesic effect than propofol8. Post
operatively, 14 patients were normal, 2 patients were mild
anxious, 2 patients were moderately anxious, and 2 patients
were severely anxious for propofol sedation and 13 patients
were normal, 2 patients were mild anxious, 3 patients were
moderately anxious, and 2 patients were severely anxious for
midazolam sedation. Both propofol and midazolam showed
similar anxiolytic property with mild variation which was not
significant9. In comparison with midazolam at equal sedation
levels, propofol was found to produce less respiratory
depression and maintains good oxygen saturation, faster time
of onset and achieving faster cognitive and psychomotor
recovery. It effectively reduced post operative nausea /
vomiting and showed reduced incidence of post operative
headache. Propofol is a beneficial intravenous conscious
sedative drug than midazolam for minor oral surgical
procedures and further studies need to be conducted in the
light of present situation, and to arrive at a definitive
conclusion.
Streamdent, 2(2), 2011
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Efficacy of Propofol and Midazolam in conscious sedation in minor oral surgery A comparative study
Summary and conclusion
From the present study, we concluded that cardiovascular
parameters were well maintained with propofol and
midazolam sedation, but propofol showed decreased heart
rate than midazolam. Respiration was well maintained with
both the drugs but midazolam has shown slight decrease in
respiratory rate. On the other hand, transient decline in
oxygen saturation was noticed with propofol. The time of
onset was faster with propofol than midazolam and the time
required for recovery from propofol was considerably less
than that of midazolam. Better amnesic property noticed in
midazolam than propofol with similar anxiolytic property.
Propofol effectively reduced post operative nausea, vomiting
and showed reduced incidence of post operative headache
than midazolam10.
In comparison with midazolam at equal sedation levels,
propofol is a beneficial intravenous conscious sedative drug
for minor oral surgical procedures.
References
1. Alkire, Michael T.Haier Richard J, Barker, Steven J;
Cerebral metabolism during propofol anesthesia in
human studies with positron emission tomography.
Anesthesiology vol 82(2) 1995:393-403.
2. Angelle M. Casagrande; propofol for office oral and
maxillofacial anesthesia: The case against low dose
katamine. J Oral Maxillofac surg 64:693-695,2006.
3. Bell G.W, P.J.Kelly; A study of anxiety, and midazolam
induced amnesia in patients having lower third molar
teeth extracted. British journal of oral and maxillofacial
surgery (2000) 38,596-602.
Streamdent, 2(2), 2011
A Gnanam et al
4. Chandra Rodrigo, Michael G.Irwin , Man Hei Wong;
Patient controlled sedation with propofol in minor oral
surgery. J oral Maxillofac. Surg. 2004;62:52-56.
5. Joseph E.Cillo ,Buffalo,NY; Propofol anesthesia for
outpatient oral and maxillofacial surgery. Oral
surg,Oral Med.Oral pathol Oral Radio Endod
1999;87:530-8.
6. Joseph E.Cilio and Richard Finn; Hemodynamics in
elderly coronary artery disease patients undergoing
propofol sedation. J Oral Maxillofac Surg 64:1338-
1342,2006.
7. Luyk N.H, B.D. Whitley; Efficacy of oral midazolam
prior to intravenous sedation for removal of third
molars. Int.J.Oral Maxillofac.Surg.1991:264-267.
8. Luyk N.H, B.D. Whitley; Efficacy of midazolam prior
to intravenous sedation for removal of third molars. Int.
J. Oral Maxillfac. Surg.1991;264-267.
9. Meyers J. Chrisopher, Eisig B. Sidney Kraut A.
Richard; Comparison of propofol and methohexital for
deep sedation. J.Oral. Maxillofac. Surg, 1994;52;449-
452.
10. Timothy T.Coyle,John F Hellfrick, Martin
L.Gonalez,Randi V Andersen, David H.Perrott; Office-
based ambulatory anesthesia ; factors that influence
patient satisfaction or dissatisfaction with deep
sedation/general anesthesia. J Oral Maxillofac surg
63;163-172,2005.
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