RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
SYNOPSIS
OF
DISSERTATION
“A COMPARITIVE CLINICAL STUDY OF INTUBATING CONDITIONS OF SEVOFLURANE WITH PROPOFOL AND HALOTHANE WITH PROPOFOL IN PEDIATRIC AGE GROUP”
Submitted by
Dr. KOMALA.H.K
M.B.B.S.
POST GRADUATE STUDENT IN
ANAESTHESIOLOGY (M.D.)
DEPARTMENT OF ANAESTHESIOLOGY
ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES,
B.G.NAGARA-571448
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / NAME OF THE CANDIDATEAND ADDRESS
(in block letters) / Dr. KOMALA.H.K
PG IN ANAESTHESIOLOGY,
ADICHUNCHANAGIRI INSTITUTE OF
MEDICAL SCIENCES.B.G NAGARA,
MANDYA DISTRICT -571448
2. / NAME OF THE INSTITUTION /
ADICHUNCHANAGIRI INSTITUTE OF
MEDICAL SCIENCES, B.G.NAGARA.3. / COURSE OF STUDY AND SUBJECT /
M.D. IN ANAESTHESIOLOGY
4. / DATE OF ADMISSION TO COURSE / 17/06/20135. / TITLE OF THE TOPIC / “A COMPARITIVE CLINICAL STUDY OF INTUBATING CONDITIONS OF SEVOFLURANE WITH PROPOFOL AND HALOTHANE WITH PROPOFOL IN PEDIATRIC AGE GROUP”
6. / BRIEF RESUME OF INTENDED WORK
6.1 NEED FOR THE STUDY
6.2 REVIEW OF LITERATURE
6.3 OBJECTIVES OF THE STUDY / APPENDIX-I
APPENDIX-IA
APPENDIX-IB
APPENDIX-IC
7 / MATERIALS AND METHODS7.1 SOURCE OF DATA
7.2 METHOD OF COLLECTION OF DATA : (INCLUDING SAMPLING PROCEDURE IF ANY)
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER ANIMALS, IF SO PLEASE DESCRIBE BRIEFLY.
7.4 HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3 / APPENDIX-II
APPENDIX-IIA
APPENDIX-IIB
YES
APPENDIX-IIC
YES
APPENDIX-IID8. / LIST OF REFERENCES /
APPENDIX – III
9. / SIGNATURE OF THE CANDIDATE10. /
REMARKS OF THE GUIDE
/ The following study will help to compare the ease of intubation with sevoflurane-propofol and halothane-propofol in pediatric age group.11 / NAME AND DESIGNATION
(in Block Letters)
11.1 GUIDE / Dr. VASANTHA KUMAR.K.R MBBS, DA, MD.
PROFESSOR,
DEPARTMENT OF ANAESTHESIOLOGY,
AIMS, B.G. NAGARA-571448
11.2 SIGNATURE OF THE GUIDE
11.3 CO-GUIDE (IF ANY) / -
11.4 SIGNATURE / -
11.5 HEAD OF DEPARTMENT / Dr. RADHA M.K, M.D
PROFESSOR AND HEAD
DEPARTMENT OF ANAESTHESIOLOGY
AIMS, B.G. NAGARA-57144811.6 SIGNATURE
12 / 12.1 REMARKS OF THE CHAIRMAN
AND PRINCIPAL / The facilities required for the investigation will be made available by the college
Dr. M.G SHIVARAMU M.B.B.S., MD
PRINCIPAL,
AIMS, B.G. NAGARA.
12.2 SIGNATURE
APPENDIX-I
6. BRIEF RESUME OF THE INTENDED WORK:
APPENDIX –I A
6.1 NEED FOR THE STUDY:
Endotracheal Intubation is the most important and crucial step during administration of general anesthesia especially in pediatric age group. It helps in maintaining the airway patency, makes procedure safe and also protects the lungs from aspiration.1
Intubation in pediatric age group is difficult as compared to the adults because of anatomical and physiological differences as they are easily prone for hypoxemia. Recently, succinylcholine administration is avoided as it may be associated with side effects such as prolonged paralysis, postoperative myalgia, malignant hyperthermia, masseter spasm, histamine release, anaphylaxis, hyperkalemia, cardiac arrhythmias and increase in intracranial or intraocular pressure. Cardiac arrest and death have been reported in young children. Even the use of non-depolarizing relaxants may be associated with undesirable effects such as prolonged neuromuscular blockade.
Hence, a technique of inducing general anesthesia with an inhalational agent is frequently employed in pediatric patients. Potent inhalational agents like halothane, sevoflurane are used to facilitate tracheal intubation. 2,3,5,6. Various studies have been done for achieving intubation in pediatric patients with higher concentration of sole inhalation agents like halothane and sevoflurane. Sevoflurane is as effective as halothane in providing smooth and rapid induction of anesthesia, while recovery is considerably faster and hemodynamic tolerance is better compared to halothane; this suggests that sevoflurane could be a useful substitute for halothane in pediatric patients 4 but only Sevoflurane 8% can be used as an alternative to facilitate tracheal intubation. However, this trend could not be accepted universally due to its associated drawbacks like: bradycardia, severe hypotension with halothane and cost ineffectiveness, hypotension with sevoflurane respectively.
Combination of lesser percentage of halothane with propofol has been studied and concluded that combination of inhalational agent and propofol is ideal for intubation in children.7 Similarly, sevoflurane is very costly, to get the same effect of smooth induction and intubation condition a combination of lesser percentage of sevoflurane with propofol is being studied with hemodynamic response with better cost effectiveness. 9, 10
Combination of sevoflurane 8% and propofol 1.5 mg kg-1 has been tried for Laryngeal Mask Airway Insertion. Induction of anesthesia with a combination of lesser dose of propofol and lesser sevoflurane with opioid premedication may optimize the inserting conditions of endotracheal tube.8
Hence, an attempt will be made to compare intubating conditions by administration of combination of sevoflurane & propofol with Halothane & propofol to evaluate hemodynamic response in pediatric patients of age group between 2 – 10 years undergoing various elective procedures.
APPENDIX –I B
6.2 REVIEW OF LITERATURE
1. Villani A, et al. conducted a randomised study on , 64 children aged 3-12 years, receiving general anaesthesia for urological, abdominal, and orthopaedic surgery, after oral flunitrazepam (0.05 mg kg-1), to compare induction, maintenance and recovery characteristics of halothane and sevoflurane when used in pediatric patients. General anesthesia was randomly induced by either sevoflurane (start: 1%, maximum: 7%, n = 32) or halothane (start: 0.5%, maximum: 4.5%, n = 32) and a 60% N2O in oxygen mixture was administered. It was concluded that sevoflurane is as effective as halothane in providing smooth and rapid induction of anesthesia, while recovery is considerably faster and hemodynamic tolerance is better compared to halothane; this suggests that sevoflurane could be a useful substitute for halothane in pediatric patients.4
2. Ghanta S, et al. conducted a randomized, controlled trial of infants who required nonemergency endotracheal intubation, to compare the efficacy of propofol, a hypnotic agent, to the regimen of morphine, atropine, and suxamethonium as an induction agent for nonemergency neonatal endotracheal intubation. Infants were randomly assigned to propofol (n = 33) and the morphine, atropine, and suxamethonium regimen (n = 30). Muscle relaxation, intubation, blood pressure, heart rates and oxygen saturation were compared. It was concluded that propofol is more effective than the morphine, atropine, and suxamethonium regimen as an induction agent to facilitate neonatal nasal endotracheal intubation and the incidence of hypoxemia was less severe.5
3. Erhan E, et al. conducted a randomized study, on 80 healthy patients were assigned to one of four groups (n = 20). After intravenous atropine, alfentanil 40 microg/kg or remifentanil 2, 3 or 4 microg/kg were injected over 90 s followed by propofol 2 mg kg(-1) to compare intubating conditions without muscle relaxants in premedicated patients. . Intubating conditions, ease of lung ventilation, jaw relaxation, laryngoscopy, position of the vocal cords, and patient response to intubation were compared. It was concluded that remifentanil 4 microg/kg and propofol 2 mg/kg administered in sequence intravenously provided good or excellent conditions for tracheal intubation in all patients without the use of muscle relaxants.6
4. Hansen D, et al. conducted a randomized study was conducted on 100 healthy children, aged 3-6yrs, to compare intubating conditions and cardiovascular changes during light halothane anesthesia and propofol 3mg kg-1 with those during deep halothane anesthesia. Light halothane anesthesia was defined as an end tidal concentration of 1%, deep halothane anesthesia as 2%, Intubating conditions were graded according to ease of laryngoscopy, vocal cord position and coughing. It was concluded that propofol administration during 1% halothane anesthesia was a reliable method for tracheal intubation in children aged 3-6yrs.7
5. Siddik-Sayyid SM, et al. conducted a randomized study on eighty-three unpremedicated ASA physical status I-II patients, to compare sevoflurane 8%-propofol1.5 mg/kg versus sevoflurane 8% or propofol 3 mg/kg for laryngeal mask airway insertion in adults. ). Propofol-induced induction of anesthesia allowed the fastest insertion of LMA and was associated with the least frequent incidence of postoperative nausea and vomiting. However, this advantage of propofol was offset by a frequent incidence of pain on injection and the occurrence of movements during insertion of the LMA. It was concluded that induction of anesthesia with sevoflurane-propofol combined provides a frequent incidence of successful LMA insertion at the first attempt that is associated with an infrequent incidence of apnea.8
6. Wappler F, et al. was conducted on 30 children who had endotracheal intubation and 30 children who had a laryngeal mask airway inserted induced with an inspiratory concentration of sevoflurane 8% in a nitrous oxide and oxygen mixture to assess the intubatory response. It was concluded that induction with sevoflurane in nitrous oxide and oxygen lead to fast loss of consciousness and provides ideal conditions for managing the airway without supplemental opioids or muscle relaxants. Furthermore, sevoflurane using this technique was very well tolerated, indicated by high haemodynamic stability and a reduced rate of postoperative restlessness, shivering, nausea and vomiting.9
7. Luntz SP, et al. conducted a randomized study on 96 patients undergoing elective ophthalmic surgery received either total intravenous anesthesia with propofol (Group P), propofol and sevoflurane induction and maintenance (Group P/S) or sevoflurane for inhalation induction and maintenance (Group S) to compare cost-effectiveness and high patient satisfaction in the elderly: sevoflurane versus propofol anesthesia. ). Analyses focussed on haemodynamics, the quality of recovery, and the costs for the anesthetic and the entire procedure. It was concluded that propofol and sevoflurane based maintenance of anesthesia were similar with regard to patient comfort and recovery in the elderly. Cost analysis revealed that it was less expensive to use propofol and sevoflurane for induction and maintenance than to use either propofol or sevoflurane as sole agents for anesthesia.10
8. Data from multiple studies have clearly shown that sevoflurane and halothane are approximately equivalent in terms of airway complications during induction of anesthetic but the rate of induction is more rapid with sevoflurane. There is a lower incidence of coughing, laryngospasm, bronchospasm, breathholding during sevoflurane induction and a higher incidence of excitement during emergence. Halothane does not have a noxious smell and is still commonly used for inhalation induction in places where budgetery concerns limit the availability of sevoflurane.11
APPENDIX –IC
6.3 AIMS AND OBJECTIVES OF STUDY
1. To study and compare the ease of intubating conditions of sevoflurane
and propofol with halothane and propofol.
2. To study the quality of intubation.
3. To study the hemodynamic response during intubation.
4. To study major and minor problems occurring during intubation.
APPENDIX-II
7. MATERIALS AND METHODS
APPENDIX-II A
7.1 SOURCE OF DATA
The study will be conducted on pediatric patients age group between 2-10 yrs, ASA-I and II, posted for various elective procedures under general anesthesia, department of anesthesiology, AH&RC, B.G.Nagara.
APPENDIX-II B
7.2 METHOD OF COLLECTION OF DATA
Methodology:
Study Design -prospective Randomized study.
60 patients of both sexes in the age group of 2-10 yrs of ASA status I and II undergoing elective surgeries under general anesthesia will be randomly allocated into two groups, group S and group H (30 each).
Group S- will be induced with sevoflurane 4% for 3 minutes and propofol 1.5mg/kg i.v.
Group H- will be induced with halothane 2% for 3 minutes and propofol 1.5mg/kg i.v
Result value will be recorded using a preset Proforma.
Duration of the study-18 months.
Procedure:
All patients will undergo pre anesthetic evaluation on the previous day of surgery. Detailed history and cardio-respiratory examination will be carried out in all patients. All relevant investigations will be done. Nil per oral status for a minimum of 6 hrs is advised and written informed consent is taken from parents.
On the day of surgery, after arrival of patient to the operation theatre, pulse oxymeter, ECG, and non-invasive blood pressure monitors will be connected. The baseline heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure will be recorded. After doing a thorough cockpit drill of continuous flow anesthesia machine and availability of emergency drugs with ETCO2 monitor, an intravenous line with Isolyte-P/ Dextrose normal saline will be secured using either 20G or 22G intravenous cannula.
All the patients will be pre-medicated with IV fentanyl 2µg/kg and glycopyrrolate 0.2mg/kg before induction. All the patients will be pre-oxygenated with 100% oxygen for 3 minutes. Anesthesia will then be induced in Group S patients by mask with sevoflurane 4% inhaled concentration with 67% nitrous oxide in oxygen at a total gas flow of 6 liters/min for 3mins and at 3rd minute IV propofol 1.5mg/kg injected with lignocaine 0.2mg/kg added to prevent pain on injection. Similarly, Group B will be induced by mask with halothane 2% for 3mins and IV propofol 1.5mg/kg injected at 3rd minute.
Tracheal intubation is attempted, when the trachea cannot be intubated, it is facilitated by either deepening anesthesia with increased concentration of inhalational agents or IV succinyl choline 1.5mg/kg or IV rocuronium bromide 1.2mg/kg will be administered intravenously in older children. Following tracheal intubation in all patients, the tube will be gently inflated after confirming the position of the endotracheal tube by auscultation of chest and capnography and anesthesia will be maintained on oxygen-nitrous oxide and inhalational agent sevoflurane or halothane for 5 mins, afterwards muscle relaxants will be administered.
The following parameters will be monitored:
· Changes in heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure before, soon after induction and intubation and post-intubation at 1, 3, and 5 mins.
· Quality of endotracheal intubation based on “Copenhagen Consensus Conference(CCC)” scoring system- vocal cords position, vocal cords movement, limb movement, coughing and quality of intubation.
· Intubation side effects: breath holding, cough, excitatory movements, laryngospasm and others like bradycardia, hypoxia, hyperthermia and hypothermia.
· Number of attempts taken for successful endotracheal intubation.
· Supplementation of endotracheal intubation with either deepening anesthesia by inhalational agent or IV succinyl choline or IV rocuronium bromide.
INCLUSION CRITERIA:
· Pediatric age group of 2-10 years of both sexes