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958
Original Article
IntroductIon
The development of minimally invasive surgery has
revolutionized surgical procedures and has inuenced the
practice of anesthesiology. The success in healthy adult patients
has led to the introduction of more extensive endoscopic
procedures in older and sicker patients, as well as in pregnant
and pediatric patients. Despite the potential advantages,
Laparoscopic procedures are associated with physiological
hemodynamic changes and life-threatening complications
such as regurgitation of the gastric contents and potential
aspiration due to physiological changes associated with
pneumoperitoneum that are usually not encountered with the
conventional open procedure. As a result, anesthetic techniques
for Laparoscopic surgery have been rened to anticipate these
differences from open surgery.[1]
Maintenance of a patent airway remains an important concern
of an anesthesiologist.[2] Even though the time tested and
excellent airway securing device, i.e., the Endotracheal
Tube (ETT), is available at all times, it too has its demerits.
Morbidities such as trauma to the vocal cords and structures of
the oral cavity, pressor response, and sore throat are worrisome
to the anesthesiologist. This led to the use of supraglottic
devices such as ProSeal laryngeal mask airway (PLMA) for
Laparoscopic surgeries.[3]
Context: The Proseal LMA(PLMA), which has been designed especially for positive pressure ventilation and protection against aspiration
can act as an alternative to Endotracheal Tube (ETT) as an effective airway device for patients undergoing elective Laparoscopic surgeries.
Aims: To compare the efcacy and safety of PLMA with ETT in patients undergoing Laparoscopic surgeries under general anaesthesia.
Settings and Design: A prospective, randomized study was conducted in a tertiary care teaching hospital with 60 patients of ASA grade I/
II undergoing elective Laparoscopic surgery under general anaesthesia .Ethical committee clearance and written consent taken. The patients
were randomly divided into two equal groups to the PLMA group (Group S) and to the ETT group (Group C) Heart rate (HR), mean blood
pressure (MAP), ETCO2 values, intraoperative complications such as regurgitation- aspiration, and Postoperative complications such as nausea
or vomiting, throat soreness and oral injuries were monitored. Results: There was no difference demographically. Insertion success rate was
100% for both the groups. The mean increase in HR was seen all throughout the duration of the surgery to 8 % above the baseline in Group C
and to 3% above the baseline in Group S. On comparing the MAP in Group C, there was a increased by 2.5% to 78.300 ± 14.2615 mmHg as
compared to an increase by 5% to 76.233 ± 6.2072 mmHg in Group S. EtCO2 showed a rise in both groups after pneumoperitoneum, which
returned to baseline values after completion of surgery. Gastric aspirate values showed no difference in each group. Post op complications
were seen mainly in Group C with statistical signicance. Conclusions: A properly positioned PLMA is a suitable and safe alternative to ETT
for airway management in adequately fasted, adult patients undergoing elective Laparoscopic surgeries.
Keywords: Effective ventilation, Endotracheal Tube, Laparoscopic surgeries, ProSeal laryngeal mask airway
Address for correspondence: Dr. Suchita Shailesh Parikh,
E‑62, Grain Merchants CHS, Plot No. 26 and 35, Sector 17, Vashi,
Navi Mumbai ‑ 400 703, Maharashtra, India.
E‑mail: drsuchitaparikh@gmail.com
ProSeal Laryngeal Mask Airway versus Cuffed Endotracheal
Tube for Laparoscopic Surgical Procedures under General
Anesthesia: A Random Comparative Study
Suchita Shailesh Parikh, Shivam Bipin Parekh1, Chaula Doshi, Varsha Vyas
Department of Anaesthesia, Dr. D. Y. Patil Medical College and Research Center, Navi Mumbai, 1Department of Critical Care, P. D. Hinduja National Hospital and
Medical Research Center, Mumbai, Maharashtra, India
Abstract
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DOI:
10.4103/aer.AER_97_17
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How to cite this article: Parikh SS, Parekh SB, Doshi C, Vyas V. ProSeal
laryngeal mask airway versus cuffed endotracheal tube for laparoscopic
surgical procedures under general anesthesia: A random comparative study.
Anesth Essays Res 2017;11:958-63.
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Parikh, et al.: The ProSeal LMA versus Endotracheal Tube for Laparoscopic surgeries
Anesthesia: Essays and Researches ¦ Volume 11 ¦ Issue 4 ¦ October-December 2017 959
PLMA is a double-lumen, double-cuff LMA. The double-tube
design separated the respiratory and the alimentary tracks
providing a separate passage for the regurgitated fluids.
Furthermore, the double cuff provided a better seal around the
glottis, thus providing an option of administering intermittent
positive-pressure ventilation[4,5] These properties increase the
suitability to use PLMA in patients who are more prone to
aspiration of regurgitated uids.
The aim of our study is to compare the efcacy and safety of
PLMA with ETT in patients undergoing Laparoscopic surgeries
under general anesthesia.
subjects and methods
Patient selection
After obtaining approval from Ethical Committee, sixty
patients were chosen who were scheduled to undergo
elective Laparoscopic surgeries under general anesthesia. The
duration of this study was 1 year. Written informed consents
were obtained from the patients. The inclusion criteria were
patients with American Society of Anesthesiologists (ASA)
Physical Status I and II, aged 18–60 years. Patients were
excluded if they had a mouth opening <2 cm, anticipated
difcult airway, ASA Physical Status III or IV, body mass
index >30 kgm−2, upper respiratory tract infection, increased
risk of aspiration (gastroesophageal reux disorder, hiatus
hernia, and pregnancy), cervical spine fracture, or instability.
The patients were randomly divided into two groups
(according to a computer generated plan) – thirty patients to
the ProSeal group (Group S) and thirty patients to the ETT
group (Group C).
Study procedure
A thorough preanesthetic checkup was performed 1 day
before the day of the surgery. All patients were given tablet
alprazolam 0.5 mg orally at bedtime on the previous night of
surgery and kept nil per oral for 12 h before surgery. After the
patient was shifted to operation theater, standard monitors such
as pulse oximeter, noninvasive blood pressure, and three-lead
electrocardiogram were connected. Intravenous (IV) access
was gained with 18-gauge cannula and Ringer’s lactate
infusion was started. The patients were given injection
glycopyrrolate 0.2 mg IV, injection midazolam 0.05 mg/
kg IV, injection fentanyl 1 µg/kg IV, injection ondansetron
4 mg IV, and injection pantoprazole 40 mg IV and then
preoxygenated with 100% oxygen for 3 min. Anesthesia was
induced with injection propofol 2.5 mg/kg IV, and injection
atracurium 0.75 mg/kg IV was used to achieve neuromuscular
blockade. The patients were ventilated for 3 min with oxygen
and isourane 0.8%, and the device was inserted by trained
anesthesia providers with signicant experience and expertise
in insertion.
• Group S (study group): PLMA (size 3 for females, size 4
for males) with introducer
• Group C (control group): cuffed ETT (size 7–7.5 ID for
females, size 8–8.5 ID for males).
Correct placement of the device was conrmed by manual
ventilation, auscultation, and square wave capnography. Once
conrmed, positive-pressure ventilation was started with a
tidal volume of 8 ml/kg. Closed circuit breathing system with
soda lime was used. Maximum three attempts were allowed
while inserting the airway device. If more than three attempts
were required for device insertion, the patient was excluded
from the study as repeated laryngoscopic response may alter
the hemodynamic parameters under study.
Ease of insertion of the device was noted.
Ryle’s tube was inserted. Correct placement of the Ryle’s tube
was checked with air injection and epigastric auscultation.
Volume of gastric aspiration was measured just after insertion
of Ryle’s tube and intraoperatively.
Anesthesia was maintained by isoflurane 0.5%–1.2%,
air: O2 (60%: 40%) connected to Drager Fabius machine
and put on volume mode along with injection atracurium
0.25–0.4 mg/kg for the maintenance of blockade. IV crystalloids
were administered after calculating fluid requirements
according to Holliday-Segar formula. CO2 pressures and ow
rates were monitored and ranged between 10 and 15 mmHg
and 200 and 400 ml/min, respectively, in all cases.
Heart rate (HR) and mean blood pressure were recorded before
induction, at 1 and 5 min after the insertion of the device,
during CO2 insufation, every 15 min interval throughout
surgery, and then 5 min after removal of airway device.
ETCO2 values were monitored similarly.
Intraoperative complications such as regurgitation-aspiration,
hypoxia, hypercarbia, bronchospasm, airway obstruction,
gastric insufation, and pneumothorax were looked for.
At the completion of surgery, isoflurane was stopped.
Residual paralysis was reversed with injection neostigmine
0.05 mg/kg and injection glycopyrrolate 0.008 mg/kg.
Postoperative analgesia was administered with IV injection
diclofenac sodium 75 mg as infusion.
The device was removed after thorough Ryle’s tube and oral
suction. Any blood or secretions present on the device were
noted.
Postoperatively, patients were monitored for vital parameters,
nausea or vomiting, throat soreness, and oral injuries.
observatIon and results
In this prospective randomized study, sixty patients
aged 18–60 years of ASA Physical Status I and II
undergoing elective Laparoscopic surgery were studied
to evaluate hemodynamic response and postoperative
complications after securing the airway with either the
ETT or the PLMA.
The sample size was determined by power analysis. Patients
listed for surgery were enrolled and assessed for eligibility.
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Anesthesia: Essays and Researches ¦ Volume 11 ¦ Issue 4 ¦ October-December 2017
960
Those not meeting the inclusion criteria or those refusing to
participate were excluded from the study.
The data collection sheets were checked daily by the principal
investigator for correctness and consistency. Data collected
were coded and entered into the SPSS software. Data were
analyzed using SPSS version 22.0 (SPSS Statistics for
Windows, Armonk, NY: IBM Corp); analysis between the
groups was done using the unpaired sample t-test while
within-group analysis was done using the paired sample t-test.
Chi-square test was used for qualitative data.
Continuous variables were described using mean ± standard
deviation. A P value of <0.05 was considered statistically
signicant.
Demographic profile
There were no statistical differences (P > 0.05) between the
groups regarding age, gender, weight, and height. All the
data were statistically insignicant and thus comparable.
Table 1 shows the comparison of demographic parameters of
all patients.
Insertion of device
Table 2 describes the insertion of device. Insertion success rate
was 100% for both the groups.
Comparison of pulse variation
Comparison of pulse variation is presented in Table 3.
Preoperatively, baseline mean pulse rate in Group S was
78.6 ± 6.27 per min and that in Group C was 79.76 ± 6.65,
with P = 0.23; thus, there was no statistical signicance in
both the groups.
During induction, there was a rise in mean pulse rate
in Group S to 81.80 ± 5.851 per min and in Group C to
82 ± 5.343 per min; however, the statistical analysis showed
no signicance.
After insertion of the device, in Group S, mean pulse rate
increased by 8% to 84.79 ± 7.497 per min, whereas in Group C,
the mean pulse rate increased by 10% to 87.5 ± 6.725 per min.
Even though there was a greater rise in mean pulse rate in
Group C as compared to Group S, there was no statistical
signicance seen as per P value.
As shown in Table 3, the mean increase in the pulse rate
was seen all throughout the duration of the surgery and
pneumoperitoneum to 8% above the baseline in Group C as
compared to 3% above the baseline in Group S. However,
there was no statistical signicance seen as per the P values.
The mean pulse rate thus showed better hemodynamic stability
in Group S as compared to Group C.
Comparison of mean arterial blood pressure variation
Comparison of mean arterial blood pressure variation is
presented in Table 4
Preoperatively, baseline mean arterial pressure (MAP) in
Group S was 74.133 ± 5.7938 mmHg and that in Group C was
75.233 ± 6.0554 mmHg, with P = 0.475; thus, there was no
statistical signicance in both the groups.
During induction, there was no signicant change in mean
MAP in both the groups.
After insertion of the device, in Group S, there was an
increase in mean MAP by 5% to 76.233 ± 6.2072 mmHg,
whereas in Group C, the mean MAP increased by 2.5% to
78.300 ± 14.2615 mmHg. Even though there was a greater
rise in mean MAP in Group C as compared to Group S, there
Table 1: Comparison of demographic parameters
Mean±SD P
Group S (n=30) Group C (n=30)
Age 34.27±11.44 34.57±9.107 0.72
Weight 53.9±9.211 53.83±8.663 0.54
Height 155.83±7.159 158.57±9.684 0.77
Male/female 8/22 5/25 0.69
Statistical test applied - Chi-square test. SD=Standard deviation
Table 2: Insertion of device
Group S (n=30) Group C (n=30)
Number of attempts
for insertion 1/2/3 (%)
100/0/0 100/0/0
Insertion
Easy 30 (with inserter) 30
Difcult Nil Nil
Table 3: Comparison of pulse variation
Time Mean±SD P
Group S
(n=30)
Group C
(n=30)
Baseline 78.60±6.278 79.76±6.659 0.23
After induction 81.80±5.851 82.00±5.343 0.32
Insertion of device 84.79±7.497 87.50±6.725 0.44
5 min after pneumoperitoneum 82.54±4.141 86.13±6.558 0.67
Removal of device 83.80±7.027 88.77±6.155 0.67
SD=Standard deviation
Table 4: Comparison of mean arterial blood pressure
variation
Time Mean±SD P
Group S
(n=30)
Group C
(n=30)
Baseline 74.133±5.7938 75.233±6.0554 0.475
After induction 75.767±6.8162 72.267±7.3669 0.061
Insertion of device 76.233±6.2072 78.300±14.2615 0.080
5 min after
pneumoperitoneum
70.333±11.7101 71.900±7.4387 0.539
Removal of device 69.967±12.6668 75.067±8.2166 0.069
5 min after removal 72.967±6.9901 72.967±6.9901 0.097
SD=Standard deviation
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Parikh, et al.: The ProSeal LMA versus Endotracheal Tube for Laparoscopic surgeries
Anesthesia: Essays and Researches ¦ Volume 11 ¦ Issue 4 ¦ October-December 2017 961
was no statistical signicance seen as per the P value. The
values of MAP gradually returned to the baseline values, with
no statistical signicance seen as per the P values. The mean
MAP thus showed better hemodynamic stability in Group S
as compared to Group C.
Comparison of end‑tidal carbon dioxide variation
Table 5 shows the comparison of end-tidal carbon dioxide
variation. On comparison, no statistical signicance was noted
in both the groups.
Comparison of gastric aspirate
Graph 1 shows the comparison of gastric aspirate variations.
On statistical analysis of the data with Chi-square test, there
was no statistical difference seen (P = 0.34) Thus, there was no
difference in the amount of gastric uid aspirated in each group.
Regurgitation of the gastric contents through the drain tube
was not seen in any of the patients. There was no case of
pulmonary aspiration.
There was no case of intraoperative displacement of the device.
Postoperative complications
Comparison of postoperative complications is presented in
Table 6. As shown in Table 6, postoperative complications such
as nausea, sore throat, and airway trauma were seen mainly
in patients with ETT (Group C) with statistical signicance
(P = 0.038, 0.002, 0.001, respectively); vomiting was not seen
in any group postoperatively.
dIscussIon
This study was carried out to compare the PLMA and the
ETT as an airway device during general anesthesia during
elective Laparoscopic surgeries in sixty ASA Grade I and
II patients who were randomly allotted into one of the two
groups containing thirty participants each, with respect to their
intraoperative hemodynamic parameters and postoperative
complications.
Both groups were given similar standardized anesthesia and
were compared for similar parameters including demographic
details, ease of insertion, volume of gastric aspirate,
hemodynamic alterations, and postoperative complications.
The two groups were comparable in terms of demographic data.
We compared the ease of insertion, attempts for insertion, and
the success rate of insertion in both groups and observed that
the insertion success rate was 100% in both.
Our ndings correlate well with Lim et al.,[6] who found that
the number of attempts for successful insertion was similar
between the both the groups and that both the devices were
successfully inserted within three attempts.
Oehler has compared different techniques of PLMA insertion.[7]
Their observation in terms of rst-time success rate at insertion
of PLMA by introducer technique and the number of attempts
for successful airway attainment coincide with our study.
On comparing the hemodynamic parameters, both the
groups were comparable in terms of baseline hemodynamic
parameters.
Our study demonstrated that there was a hemodynamic
response consisting of an increase in HR and MAP associated
with laryngoscopy and ETT insertion as well as with PLMA
insertion. The response caused by laryngoscopy with ETT
insertion was greater than that caused by PLMA insertion.
However, no statistical signicance was noted. Similar results
were seen by Güleç et al.,[8] who concluded that PLMA usage
is a suitable, effective, and safe alternative to ETT in patients
with lower metabolic stress.
The hemodynamic parameters were elevated to 10%–15% above
the baseline values after the insertion in patients of the ETT
group and gradually settled to 5%–8% above the baseline for the
remaining duration of the surgery. These results are comparable
16.7 16.7
3.3
23.3
20.0
3.3
0.0
5.0
10.0
15.0
20.0
25.0
<5 ml 5–10m
l>
10ml
Percentage
ProSeal LMA
ET Tube
Graph 1: Comparison of gastric aspirate variations
Table 5: Comparison of end‑tidal carbon dioxide variation
Time Mean ETCO2±SD P
Group S (n=30) Group C (n=30)
Insertion of device 32.033±1.4967 32.700±1.0554 0.051
After insertion 32.267±1.8742 32.933±1.1121 0.099
After
pneumoperitoneum
35.600±1.7140 36.000±1.8004 0.382
5 min after
pneumoperitoneum
32.217±1.5654 31.867±1.5976 0.507
SD=Standard deviation, ETCO2=End tidal carbon dioxide
Table 6: Comparison of postoperative complications
Group S (n=30) Group C (n=30) P
Incidence Percentage Incidence Percentage
Nausea 4 6.67 10 16.67 0.038
Sore throat 0 0 8 13.33 0.002
Airway
trauma
0 0 1 1.67 0.0001
Vomiting 0 0 0 0 -
Total 30 100 30 100
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Parikh, et al.: The ProSeal LMA versus Endotracheal Tube for Laparoscopic surgeries
Anesthesia: Essays and Researches ¦ Volume 11 ¦ Issue 4 ¦ October-December 2017
962
to those found by Kanchi et al.[9] and Takahashi et al.,[10]
who found that in normotensive patients, laryngoscopy and
endotracheal intubation are immediately followed by an increase
in the sympathetic response and hemodynamic parameters.
The PLMA group in our study showed a 6%–8% increase in
hemodynamic parameters after insertion, which was lower than
that seen in patients with ETT. These parameters gradually
settled to 1%–3% above the baseline for the remaining duration
of the surgery.
These ndings are supported by Misra and Ramamurthy[11]
and Lim et al.,[6] who concluded that the PLMA is a similarly
effective airway device to conventional laryngoscope-guided
tracheal intubation but is more rapidly inserted and associated
with an attenuated hemodynamic response to insertion and
removal.
Idrees and Khan[12] noted that the hemodynamic response
to insertion was signicantly attenuated in LMA group as
compared to ETT group. They concluded that this attenuated
hemodynamic response to insertion of LMA as compared
to ETT will be beneficial in patients with compromised
cardiovascular prole, and hence, it has a safer hemodynamic
prole compared to ETT.
Laparoscopic surgery cause changes in respiratory mechanics
following carbon dioxide pneumoperitoneum. The pulmonary
compliance is decreased and the resistance is increased leading
to high airway pressure. Therefore, higher inspiratory pressures
are required to provide adequate tidal volume and minute
ventilation to maintain adequate airway pressures and end-tidal
carbon dioxide levels.[13,14]
On comparing the mean end-tidal carbon dioxide levels
in both the groups, the values of ETCO2 were comparable
in both the groups on insertion of the airway device;
however, there was a rise in both groups after laparoscopy
and pneumoperitoneum, which returned to baseline values
after completion of surgery. This variation was comparable
all throughout the duration of surgery with no statistically
signicant difference.
Ryle’s tube was inserted successfully in all our patients in
the rst attempt along with the insertion of either device.
In comparison, Cook et al.[15] were successful in 92%.
Sharma et al.[16] had a success rate of gastric tube placement
of 100%.
On comparing the mean values of gastric aspirate in both
groups, we noted minimal mean gastric aspirate in both the
groups with no statistical signicance. This could be attributed
to elective nature of the surgery where appropriate aspiration
prophylaxis was administered. Regurgitation of the gastric
contents through the drain tube was not seen in any of the
patients.
Cook et al.[17] observed that the drain tube enables early
diagnosis of mask misplacement, allows gastric drainage,
reduces gastric ination, and may vent regurgitated stomach
contents and also that the correctly placed PLMA reduces
aspiration risk Evans et al.[18] described a case of intraoperative
passive regurgitation where the PLMA successfully protected
the airway from the respiratory tract illustrates that passive
regurgitation can occur unexpectedly intraoperatively and
thus the PLMA can protect the airway during such an event
by allowing the regurgitated uid to pass up the drainage tube
without leaking into the glottis.
We compared postoperative complications such as nausea,
vomiting, airway trauma, and sore throat in both the groups.
16.67% patients in ETT group experienced nausea 6.67%
patients in PLMA group. These values were statistically
signicant. 13.33% patients in the ETT group had sore throat
postoperatively. No patient in the PLMA group experienced
this complication, which was statistically signicant.
Airway trauma was seen in 1.67% of all the cases. This was
highly statistically signicant.
Higgins et al.[19] showed that patients with ETT had the greatest
incidence of sore throat; 45.4%, followed by patients with
LMA.
Saraswat et al.[20] found that sore throat postoperatively was
seen in 10% patients with PLMA and in 20% patients with
ETT and noted airway trauma in 10% patients with PLMA
and in 16.67% patients with ETT.
No incidence of vomiting postoperatively in any groups. This
could be attributed to appropriate antacid prophylaxis and
Ryle’s tube suctioning, before extubation.
summary and conclusIon
We summarize that in the patients undergoing elective
Laparoscopic surgeries:
1. The PLMA has similar ease of insertion as the ETT
2. PLMA has better hemodynamic stability
3. PLMA is an equ ally good conduit for delive r y of positive
pressure ventilation and provides an effective airway
seal with minimal chances gastric distension and but no
regurgitation or aspiration in patients undergoing general
anesthesia during Laparoscopic surgeries
4. PLMA reduces the chances of postoperative complications
such as nausea, sore throat, and vomiting and airway
trauma and hence is desirable especially for day care
procedures.
Hence, we conclude that a properly positioned PLMA is a suitable
and safe alternative to ETT for airway management in adequately
fasted, adult patients undergoing elective Laparoscopic surgeries.
It provides equally effective pulmonary ventilation without
gastric distention, regurgitation, and aspiration.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conicts of interest.
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