Rajiv gandhi university of health sciences, bangalore karnataka annexure-ii




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TitleRajiv gandhi university of health sciences, bangalore karnataka annexure-ii
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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE

KARNATAKA


ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION




1.


Name of the candidate

& address


Dr. AMRUTHA BINDU B. N.

POST GRADUATE IN THE DEPT. OF

ANAESTHESIOLOGY,

BANGALORE MEDICAL COLLEGE &

RESEARCH INSTITUTE,

BANGALORE.



2.


Name of the Institution


BANGALORE MEDICAL COLLEGE &

RESEARCH INSTITUTE, BANGALORE



3.


Course of study & Subject


DOCTOR OF MEDICINE IN ANAESTHESIOLOGY



4.

Date of Admission to course


05-05-2010



5.


Title of the topic


A COMPARATIVE STUDY OF EFFECTS OF DIFFERENT DOSES OF FENTANYL INFUSION ON THE EMERGENCE CHARACTERISTICS AFTER SEVOFLURANE ANESTHESIA IN CHILDREN.


6.

Brief resume of the intended work









6.1



Need for the study


Sevoflurane is highly acceptable for paediatric anesthesia as a sole agent, owing to its physical properties and safety profile. But studies have shown that its use is associated with increased occurrence of Emergence Agitation in the early recovery period.(1,2,3)

Various drugs like midazolam, clonidine, propofol, fentanyl, dexmedetomidine have been tried to reduce its occurrence, with varying results. Studies using Fentanyl have reported a reduction in its occurrence.(4,5,6) However, minimum dose of Fentanyl that can be used has not been established. We intend to take up a Comparative Study using two different doses of Fentanyl and assess their effects on the Emergence Characteristics after Sevoflurane anesthesia.






6.2

Review of literature


Aono J and others conducted their study for Emergence Delirium in pre-school boys undergoing minor urological surgeries. Their study concluded that incidence of Emergence Delirium was significantly higher with Sevoflurane than Halothane .(1)

Cravero J et al study also showed higher incidence of Emergence Agitation with Sevoflurane than Halothane in their study on children undergoing General Anesthesia for non surgical purposes.(2)

Vlajkovic and others have listed various factors implicated in the occurrence of Emergence Agitation in children in the post operative period, and methods of prevention and treatment for the same.(3)

Galinkin and co workers studied the efficacy of intra nasal Fentanyl 2µg/kg and proved it to be useful in reducing the occurrence of post operative agitation, without significant side effects.(4)

Cohen and others used a concurrent 2.5µg/kg bolus dose of Fentanyl and proved it to be effective in reducing the incidence of Emergence Agitation in children.(5)

Ionomata and others studied the effects of Fentanyl infusion on tracheal intubation and emergence agitation in pre-school children anesthetised with Sevoflurane. They concluded that Fentanyl facilitates tracheal intubation and smoother emergence in children anesthetized with Sevoflurane, in a dose dependent manner.(6)







6.3


Aims and Objectives of the study


1. To study the effects of Fentanyl on the Emergence

Characteristics after Sevoflurane anesthesia in

children.

2. To study the effect of different doses of Fentanyl on

the occurrence of Emergence Agitation.

3. To study any other effects of Fentanyl in children

when used intra operatively.


7.

Materials & Methods






7.1


Source of Data


100 children of American Society of Anesthesiologists grade I and II, aged 4 to 7 years undergoing elective surgical procedures under General Anesthesia in Vanivilas Hospital, Victoria Hospital, Bowring and Lady Curzon Hospitals, Bangalore attached to BMCRI, Bangalore will be included in the study. The study will be conducted from November 2010 to October 2012. 50 children will be studied under each group.






7.2


Method of collection of Data


Children will be included in the study after applying the following criteria.


Inclusion Criteria

1. Pediatric patients in the age group of 4-7 years.

2. ASA I and II.

3. Undergoing elective surgical procedures under

general anesthesia.


Exclusion Criteria

  1. Children with neurological disorders or undergoing

treatment for the same.

  1. Children with psychiatric illnesses or undergoing treatment for the same.

  2. Children undergoing Ear, Nose and Throat surgeries

  3. Children with previous history of surgery.



5. Children with history of head injury.

6. Children with symptoms of respiratory infection.

7. Children with hypersensitivity to opioids.

8. Children with renal, hepatic and metabolic

disorders.


Children will be observed post operatively for one hour and Emergence Agitation assessed using a Paediatric Anesthesia Emergence Delirium Scale. (Annexure 1)


To maintain the power of the study at 80%, and level of significance fixed at 5%, the sample size required is about 100(making provisions for missing data).






7.3


Methods of study


Children included in the study will be randomly allocated into 2 groups.


Group 1- receiving a bolus of Fentanyl 1 μg/kgbw followed

by an infusion of 0.5 μg/kgbw/hr.


Group 2- receiving a bolus of Fentanyl 2 μg/kgbw

followed by an infusion of 1 μg/kgbw/hr.


Preoperatively, children will be examined thoroughly and anxiety levels assessed. Play toys shall be provided to allay anxiety. i.v. line will be secured and Syrup Diphenhydramine 1.25mg/kgbw will be administered orally the previous night.

On taking the child into the operation theatre, child will be induced with 6-8 % conc. Sevoflurane.

Inj. Glycopyrrolate 0.01mg/kgbw, Inj. Ondansetron 0.1mg/kgbw and Inj. Fentanyl bolus (depending on the group child belongs to) will be administered. Following intubation with appropriate size endotracheal tube, maintenance of anesthesia will be done using 50% O2:N2O mixture and sevoflurane to maintain a MAC of 1.5. Fentanyl infusion will be started after intubation and will be continued till the end of the surgical procedure. Appropriate doses of Atracurium will be used for muscle relaxation. Child will be reversed and extubated after evidence of spontaneous efforts.

Child’s behavior will be assessed and scored using PAED scale for one hour in the recovery room.(Annexure 1)


Statistical analysis

Based on the type of measurements, Chi square test/ Fischer’s exact probability test for Categorical data and Student t test for continuous data will be used to draw the inference.






7.4


Does the study require any investigations or interventions to be conducted on patients and other humans or animals? If so, please describe briefly.


Routine investigations like hemoglobin %, urine protein and sugar, bleeding time and clotting time will be done in children included in the study.






7.5


Has ethical clearance been obtained from your institution in case of 7.3?


Yes



8.


References




  1. Aono J, Ueda W, Mamiya K, Takimoto E,Manabe

Greater incidence of Delirium during Recovery

from Sevoflurane anesthesia in Preschool Boys.

Anesthesiology 1997;87:1298-300.



  1. Cravero J, Surgeoner S, Whalen K.

Emergence Agitation in Paediatric patients after

Sevoflurane anesthesia and no surgery: a

Comparison with Halothane. Paediatric Anesthesia

2000;10:419-24.



  1. Vlajkovic GP, Sindjelic RP. Emergence Delirium in Children: Many Questions, Few Answers. Anesthesia Analgesia 2007;104;84-91.




  1. Jalinkin JL,Fazi LM,Cuy RM, Chiavacci RM, Kurth CD, Shah UK et al Use of intranasal Fentanyl in children undergoing Myringotomy and Tube placement during Halothane and Sevoflurane anesthesia.Anesthesiology 2000;93:1378-83.




  1. Cohen I, Finkel JC,Hannallah RS, Hummer KA, Patel KM. The effect of Fentanyl on the Emergence Characteristics after Desflurane or Sevoflurane anesthesia in Children. Anesthesia and Analgesia 2002;94(5):1178- 81.




  1. Ionomata S, Maeda T,Shimizu, Satsumae T, Tanaka M. Effects of fentanyl infusion on tracheal intubation and emergence agitation in preschool children anesthetised with Sevoflurane. British Journal of Anesthesia 2010;105(3):361-7.





9.


Signature of the candidate








10.



Remarks of the Guide





11.


Name and Designation (in block letters)

    1. Guide




    1. Signature




    1. Co-Guide

( if any)

    1. Signature




    1. Head of the Dept.




    1. Signature








12


12.1 Remarks of

the Chairman

and Principal


12.2 Signature






Annexure 1


Paediatric Anesthesia Emergence Delirium Scale


Score


  1. The child makes eye contact with care giver. 4 = not at all

3 = just a little

  1. The child’s actions are purposeful. 2 = quite a bit

1 = very much

  1. The child is aware of his/her surroundings. 0 = extremely



0 = not at all

  1. The child is restless. 1 = just a little

2 = quite a bit

  1. The child is inconsolable. 3 = very much

4 = extremely


Maximum Score is 20.


A child with a score of or more than 10 is considered to be

agitated or delirious.

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