SYNOPSIS
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE.
ANNEXURE – II
PROFORMA FOR REGISTRATION OF THE SUBJECT FOR DISSERTATION
1. / Name of the Candidate and Address[in block letters] / DR. JITHUMOL THANKAM THOMAS
P.G. RESIDENT,
DEPARTMENT OF ANAESTHESIOLOGY,
ST. JOHN’S MEDICAL COLLEGE ,
BANGALORE – 560 034.
2. / Name of the Institution / ST. JOHN’S MEDICAL COLLEGE,
BANGALORE – 560 034.
3. / Course of study and subject / M.D. ANAESTHESIOLOGY
4. / Date of Admission to Course / 01.06.2013
5. / TITLE OF THE TOPIC:
“COMPARISON OF THE HEMODYNAMIC RESPONSES WITH LARYNGEAL MASK AIRWAY VS ENDOTRACHEAL INTUBATION IN ADULTS UNDERGOING GENERAL ANAESTHESIA FOR ELECTIVE SURGERIES
BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
The choice of securing the airway during general anaesthesia
often lies between endotracheal intubation and insertion of the
laryngeal mask airway.It has been hypothesized that both are
associated with some degree of pressor responses due to reflex
sympathetic discharge in response to laryngotracheal
stimulation which in turn leads to increased catecholamine
release.
These hemodynamic changes are probably of little consequence
in normal, healthy individuals , but maybe more severe or even
dangerous in patients with underlying co-morbidities. It may
lead to complications like myocardial infarction, left ventricular
failure,Cerebro vascular accidents ,intracranial hypertension
and rise in intra ocular pressure.1
Many methods have been utilized to attenuate the
pressor responses following the insertion of endotracheal tube
like deepening the level of anaesthesia and various
pharmacological approaches which include the use of
lignocaine, esmolol, nitroglycerine, magnesium sulphate,
verapamil , nicardipine and diltiazem2.
In 1983 , Archie I.J Brain developed the laryngeal mask
airway(LMA) which provides a useful alternative for airway
management during spontaneous or controlled ventilation. It
filled the niche between oropharyngeal airway and
endotracheal tube .Use of laryngeal mask airway in place of
endotracheal tube has been observed to have less
hemodynamic responses after its insertion , as its insertion
requires neither visualisation of cords nor the penetration of
larynx. Studies are plenty in literature on the hemodynamic
responses to Endotracheal intubation when compared to
laryngeal mask airway .Takita K et al studied attenuation of
cardiovascular responses to endotracheal intubation with
tracheal Lidocaine 3.Maguire A.M et al compared the effects of
remifentanil and alfentanil on cardiovascular responses to
tracheal intubation in hypertensive patients4.Farooq M et al
studied management of cardiovascular responses to
laryngoscopy and tracheal intubation using Esmolol
hydrochloride5.
Various committees and societies have been advocating the use
of Laryngeal mask Airway in different situations. New
guidelines by DAS (Difficult Airway Society) for
intubation and extubation protocols in difficult airway
management advocates the use of Laryngeal Mask Airway
nowadays and attempts are being made in designing newer
models of laryngeal mask airways to make it a more ideal
airway device.
Based on these facts we intend to investigate the hemodynamic
changes with LMA(LMA-classic) vs Endotracheal tube among
patients undergoing General anaesthesia posted for elective
surgery of less than 2 hours duration and to determine if
laryngeal mask airway could be an acceptable alternative
airway device to endotracheal tube for short to moderate
duration surgeries in our hospital setup where the trend is
towards using Endotracheal tube.
6.2 REVIEW OF LITERATURE:
M Shafique Tahir et al (2008) did a prospective comparative study to test the hypothesis that Laryngeal mask airway is associated with less pressor responses than endotracheal intubation. A statistically significant rise in heart rate , systolic and diastolic blood pressure was seen after tracheal intubation (p <0.05) . Following laryngeal mask airway insertion, the rise in heart rate was statistically significant(p<0.05) while there was not much difference in rise in systolic and diastolic blood pressure.The increase in heart rate was significantly more marked in Endotracheal tube group than Laryngeal mask airway group and this increase remained significant upto 5minutes after insertion. It was therefore concluded that endotracheal intubation is associated with significantly marked increase in heart rate , systolic and diastolic blood pressure compared to that associated with Laryngeal mask airway. So Laryngeal mask airway can be used in situations where minimal changes in hemodynamics are desirable like in patients with coronary artery disease with no contraindications for using Laryngeal mask airway.
Dipashri Bhattacharya et al(2008) did a randomised controlled study in patients with controlled hypertension to determine the pressor responses following insertion of Laryngeal mask airway as compared to endotracheal intubation. It was observed that tracheal intubation was associated with increase in heart rate from 84 ±7.80 to 86 ± 6.17 ( p<0.05) and significant increase in systolic blood pressure from 128.60±7.44 to 166.20±8.9 and diastolic blood pressure from 80.70±5.18 to 90.05±2.39(p< 0.01) as compared to insertion of Laryngeal mask airway.Hence it was concluded that insertion of Laryngeal mask airway was associated with lesser pressor responses as compared to endotracheal intubation in patients with controlled hypetension..It is an effective method to avoid laryngoscopic pressor responses during endotracheal intubation in hypertensive patients.
Ismail SA et al(2011) tested the hypothesis that the effects of insertion of an i-gel supraglottic airway management device on intraocular pressure(IOP) and hemodynamic variables would be milder than those associated with insertion of a laryngeal mask airway(LMA) or an endotracheal tube. It was concluded that insertion of endotracheal tube increased the IOP, Heart rate, Systolic and diastolic blood pressure significantly.These increases were significantly higher than those which followed insertion of i-gel.Thus it was concluded that insertion of the
i-gel device provides better stability of IOP and the hemodynamic system compared with the insertion of an endotracheal tube or LMA .
Namita Saraswat et al (2011) did a prospective controlled study to compare the efficacy of Proseal laryngeal mask airway and endotracheal tube in patients undergoing laparoscopic surgeries under General Anaesthesia. It was concluded that properly positioned Proseal laryngeal mask airway proved to be a suitable and safe alternative to Endotracheal tube for airway management in elective fasted , adult patients undergoing laparoscopic surgeries. It provided equally effective pulmonary ventilation without gastric distension , regurgitation and aspiration.
O Ajuzieogu et al (2013) did a prospective , randomized controlled study to compare the blood pressure and heart rate changes after insertion of laryngeal mask airway and endotracheal intubation .It was concluded that insertion of Endotracheal tube was associated with a more significant increase in blood pressure. And that in patients in whom increased stress reponses to a insertion of Endotracheal tube may represent a health hazard the Laryngeal mask airway should be used where possible.
Braude N et al (1989) studied the pressor responses of tracheal intubation with that of laryngeal mask insertion.It was shown that a similar , but attenuated pattern of response is associated with laryngeal mask insertion in comparison with laryngoscopy and intubation, significant differences between the two were evident in arterial diastolic blood pressure immediately after insertion and again 2 minutes later.Use of laryngeal mask airway therefore offer some advantages over tracheal intubation in the anaesthetic management of patients where the avoidance of pressor responses is of particular concern.
Hosam M Atef et al(2013) did a prospective, randomized controlled comparative study to evaluate the efiicacy of Perfusion Index for detecting hemodynamic stress responses to inserton of i-gel, Laryngeal mask airway and endotracheal tube and compare its reliability with the conventional hemodynamic criteria in adults during General Anaesthesia.It was concluded that perfusion index is a reliable and easier alternative to conventional hemodynamic criteria for detection of stress response to insertion of i-gel , Laryngeal mask airway and Endotracheal tube during propofol fentanyl isoflurane anaesthesia in adult patients.
6.3 OBJECTIVES OF THE STUDY:
1. To compare the hemodynamic responses of LMA vs Endotracheal tube in adults undergoing GA for elective surgeries of less than 2 hours duration
2. To study the immediate postoperative complications of Laryngeal mask airway and endotracheal intubation
(Postop sore throat, Hoarseness of voice, postop nausea
and vomiting)
7. / MATERIAL AND METHODS
7.1. Source of data: ASA Physical status I & II adults patients who will undergo elective surgeries under General anaesthesia in ST JOHN’S MEDICAL COLLEGE HOSPITAL will be included in the study.
7.2. Method of collection of data:
Study type : Prospective randomized controlled study
Duration of study :Jan 2014 to Aug 2015
Sample size: By power analysis based on study by Hosam M Atef et al , with Type 1 error of 5 and Type 2 error of 20, power 80%, 110 ASA I & II adults patients who will undergo elective surgeries of less than 2 hours duration under General anaesthesia will be included in the study.
Inclusion criteria-
110 ASA physical status I & II patients from both genders ,
in the age group 18-50 yrs, scheduled for elective surgical
procedures, of duration less than 2 hours will be enrolled
for the study.
Exclusion criteria-
Patients who are
- obese, pregnant,
-difficult intubation(Mallampatti III and IV) ,
-with h/o COPD, h/o autonomic neuropathy,
-patients undergoing head and neck surgeries,
-surgeries where prone positioning is required
-patient in whom more than 1 attempt at
insertion of airway device was required will be
excluded from the study.
The patients will be randomized via computer generated table :
Group I: Airway is secured using Laryngeal Mask Airway(LMA-classic)
Group II: Airway is secured using Endotracheal tube
Preoperative assessment: Preoperative evaluation of all the patients will be performed with detailed history, physical examination including height, weight, airway examination and systemic examination. The basal heart rate and blood pressure will be recorded prior to surgery . All the patients will be kept nil per oral for 8 hours. All patients will be premedicated which includes ranitidine 150 mg on the night before surgery and also 2 hours prior to surgery and Alprazolam 0.25mg on the night before surgery with sips of water. Informed valid written consent for participation in the study will be taken from all the patients.
Intraoperative assessment: Patient will be randomly allocated into either Group I (LMA-classic)) or GroupII(Endotracheal intubation). Intravenous access is obtained in all patients . In all selected patients pre-induction(baseline) systolic blood pressure(SBP) , diastolic blood pressure(DBP) , mean arterial pressure(MAP), pulse rate(HR) and oxygen saturation(SpO2) will be recorded. Patient will be preoxygenated with 100% O2 . Anaesthesia will be induced with intravenous Propofol 2mg/kg , Fentanyl 2mcg/kg and Atracurium 0.6 mg/kg will be administered for mechanical ventilation. Insertion of airway device will be attempted 3 minutes after induction.
In the ET group, intubation of the trachea will be attempted with a cuffed tracheal tube (internal diameter 7.5 mm for women and 8.5mm for men) using direct laryngoscopy.In the LMA classic group , the size 3/4 for women and size 4/5 for men will be chosen . Patients’ lungs will be mechanically ventilated and minute volume set to maintain end-tidal CO2 at 30-35 mm Hg . Isoflurane will be used to maintain adequate level of anaesthesia with N2O/oxygen mixture in 50%:50% volume ratio. Systolic and diastolic blood pressure,Mean arterial pressure , Heart rate and Spo2 will be measured before induction and after insertion of the airway device every minute for the first 10 minutes and every 5 min for the first half hour following insertion of the airway device.
Data Analysis
Data will be analyzed for the statistical significance using Independent t test for repeated measures.
7.3 Does The Study Require Any Investigations Or Interventions To Be Conducted On Patient Or Other Human Or Animals?
Yes…Intervention being using an LMA or Endotracheal tube
7.4 Has Ethical Clearance Been Obtained From Your Institution In Case Of 7.3?
Yes
8. / LIST OF REFERENCES:
1. Tahir MS, Khan NA, Masood M, Yousaf M,Warris S A comparison of pressor responses following laryngeal mask airway Vs Laryngoscopy and Endotracheal Tube insertion, Anaesthesia, Pain & Intensive care 2008; 12(1):11-15
2. Bhattacharya D, Ghosh S , Chaudhuri T , Saha S. Pressor responses following insertion of laryngeal mask Airway in patients with controlled Hypertension: Comparison with Tracheal Intubation. J Indian Medical Association 2008;106:787-90
3. Takita k,Morimoto Y,Kmmotosa O.Tracheal lidocaine attenuate the cardiovascular response to endotracheal intubation.
Canadian J Anaesthesiology 2001;48:732-6
4. Maguire A.M, Kumar N, Parker J.L, Robotham D.J,Thompson J.P. Comparison of effects of remifentanil and alfentanil on cardiovascular responses to tracheal intubation in hypertensive patients.Br J Anaesth2001;86:90-3
5. Farooq M,Butt HA,Chaudry AH.Management of cardiovascular stress response to laryngoscopy and tracheal intubation using Esmolol hydrochloride. Ann KE Med Cill 1999;5:128-30
6. Ismail SA, Bisher NA, Kandil HW, Mowafi HA, Atawia HA. Intraocular pressure and hemodynamic responses to insertion of the i-gel, Laryngeal mask airway or Endotracheal intubation.European J Anaesth 2011; 28(6):443-8
7. Braude,N,Clements,E.A.F,Hodges,U.M.andAndrews,B.P.The pressor response and laryngeal mask airway insertion. Anaesthesia 1989; 44(7) :551-4
8. Wilson JG,Fel D, Robinson SL,Smith G,Cardiovascular responses to insertion of laryngeal mask airway. Anaesthesia1992;47:300-2
10 Saraswat N, Kumar A, Mishra A, Gupta A , Saurabh G,
Srivastava U. The comparison of Proseal Laryngeal mask airway and Endotracheal tube in patients undergoing laparoscopic surgeries under general anaesthesia.Indian J Anaesthesia 2011;55:129-34
11 Atef HM , Fattah SA, Abd Gaffer ME, Al Rahman AA.
Perfusion -Index versus non invasive hemodynamic
parameters during inserton of i-gel. LMA and endotracheal
tube .Indian J Anaesthesiology 2013; 57(2)156-62
12 Kihara S, Brimacombe J,Yaguchi,Watanabe S,TaguchiN, Komatsuzaki T.Hemodynamic responses among three tracheal intubation devices in normotensive and hypertensive patients.Anesth Analog 2003;96:890-5
13. Lamb K, James MF and Janicki PK. Laryngeal mask airway for
intraocular surgery, effects on Cardiovascular reactions to
laryngoscopy and intraocular pressure and stress responses .
Br J Anaesth 1992;69:143-7.
14. Hickey S, Cameron AE, Asbury AJ.Cardiovascular response to
insertion of Brain’s laryngeal mask.Anaesthesia 1990;45:629-33.
15. Imai M,Matsumura C,Hanaoka Y,Kemmouts UO.Comparison of
cardiovascular response to airway management using a new
adaptor,laryngeal mask insertion or conventional laryngoscopic
intubation.J Clinical Anesth 1995;7:14-8
9 / SIGNATURE OF THE CANDIDATE:
10 / REMARKS OF THE GUIDE: / .
11 / NAME & DESIGNATION OF
11.1.GUIDE / DR. SATHYANARAYANA P S
PROFESSOR,
DEPARTMENT OF ANAESTHESIOLOGY,
ST JOHN’S MEDICAL COLLEGE
BANGALORE – 570034.
11.2.SIGNATURE
11.3.HEAD OF DEPARTMENT / DR. VASUDEVA UPADHYAYA K S
PROFESSOR AND HEAD,
DEPARTMENT OF ANAESTHESIOLOGY ,
ST JOHN’S.MEDICAL COLLEGE,
BANGALORE – 570034.
11.4.SIGNATURE
12 / 12.1.REMARKS OF THE CHAIRMAN AND PRINCIPAL
12.2.SIGNATURE
1