RAJIVGANDHIUNIVERSITY OF HEALTH AND SCIENCES

BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTION

1. / Name of candidate and address / Dr NAVYA C N
PG STUDENT
DEPARTMENT OF ANESTHESIOLOGY
S NIJALINGAPPAMEDICALCOLLEGE AND HSKHOSPITAL AND RESEARCH CENTRE
BAGALKOT – 587102
2. / Name of institution / S NijalingappaMedicalCollege And HSKHospital And Research Centre
Bagalkot - 587102
3. / Course of study and subject / M D Anesthesiology
4. / Date of admission to the course / 31/05/2011
5. / Title of the topic / A comparative study between intra venous Dexmedetomidine and Esmolol in attenuation of cardiovascular response to laryngoscopy and endotracheal intubation – A Randomized Clinical Trial
6. / Brief resume of the intended work
6.1 / Need for study
Stress response under anesthesia has long been universally recognized phenomenon which may be in the form of endocrine or autonomic disturbance. There is increase in heart rate, blood pressure and arrhythmias.1 Increase in intraocular and intracranial pressure is also noted.These changes are maximum at 1 min after intubation and last for 5-10 min.
Various pharmacological methods have been aimed to suppress this pressor response but the search for the ideal drug for attenuation of cardiovascular response during laryngoscopy and tracheal intubation continues.
Dexmedetomidine is a highly selective and specific 2 adrenoreceptor agonist, with dose-dependent reductions in intraocular pressure2, blood pressure and heart rate, also has analgesic, sedative, and sympatholytic effects.3
Esmolol is an ultra short acting 1 adrenergic blocker. It has rapid onset and a short duration of action. However, no consensus has been reached regarding optimum dose, the mode or timing of its delivery.4
Both dexmedetomidineandesmolol have been used for the attenuation of adrenergic response to laryngoscopy and tracheal intubation.5
The aim of this study is to compare effectiveness of Dexmedetomidine 1g/kgand Esmolol 1mg/kg in attenuating cardiovascular response during laryngoscopy and intubation in ASA I and ASA II patients of SNMC Bagalkot.
6.2 / Review of literature

King1 et al., in 1951, conducted the evaluation of cardiovascular changes that accompany laryngoscopy and tracheal intubation. Keniya2et al., concluded that perioperative infusion of Dexmedetomidine is effective in attenuating sympathoadrenal response to tracheal intubation, also has significant anesthetic and opioid sparing effect.

Jaakola3 et al., have reported attenuation of increase in heart rate and arterial pressure during intubation by a bolus injection of 0.6g/kgDexmedetomidine, 10 min before induction and decrease in intraoperative intra ocular pressure and anesthetic requirement for thiopentone and Isoflurane. The continuous infusion of Dexmedetomidine has also shown to decrease Propofol requirements in volunteers and patients.

Bensky4 et al., suggested small doses of Esmolol 0.2 or 0.4 mg/kg may block the increase in heart rate and blood pressure resulting from laryngoscopy and intubation.

Yavascaoglu5 and colleagues reported attenuation of increase in heart rate and arterial pressure with single low dose Dexmedetomidine 0.5 g / kg, also showed decrease in intraocular pressure, and requirement of Propofol induction dose, but Esmolol 0.5mg/kg was found to be ineffective in attenuation of intra ocular pressure and hemodynamic response to tracheal intubation.

Areas that need further investigations being,to findthe ideal drug, timing of single intravenous bolus and optimal dose of the stress attenuators.

Magnitude of the problem and the need for further exploration: ever since the identification of pressor response to laryngoscopy and intubation, the search for the ideal drug to attenuate the same continues as the stress may not betolerated by patients with compromised cardiac status.
The specific area that the proposed study is trying to address: Effectivenessof Dexmedetomidine at g/kg andEsmolol at 1mg/kg for attenuation of hemodynamic stress response during laryngoscopy and intubation.
6.3 /

Objectives of study

To compare effectiveness of Dexmedetomidine at a dose of 1g/kg with Esmolol at a dose of 1mg/kgin attenuating cardiovascular response to laryngoscopy and endotracheal intubation.
7. / Materials and methods
7.1 / Source of data
Patients of S NijalingappaMedicalCollege and HSKHospitaland Research Centre, Bagalkot.
7.2 / Method of collection of data (including sampling procedure, if any)
Study design
Single blind randomized clinical trial
Study area
S Nijalingappa Medical College and HSK hospital and research centre, Bagalkot
Study population
Agegroup: 18-65years who require tracheal intubation for elective, non cardiac surgery in either gender.
Inclusion Criteria:
  • ASA I or II (no or minimal co-morbid disease)
  • Patients scheduled for elective surgeries
Exclusion Criteria:
  • History of allergy or contraindications to either Dexmedetomidine or Esmolol
  • Concomitant use of medications which may exaggerate the heart rate response of Dexmedetomidine including digoxin or β-adrenergic antagonists.
  • Predicted difficulty in intubation, pregnancy, nursing women and morbid obesity
  • Coronary artery disease, ischemic heart disease, heart blocks.
Study period
One year(1 January 2012 to 31 December 2012).
Study sample size
100 ASA I and II patients with 50 in each of two groups.
Sampling frame
All in patients of SNMC requiring laryngoscopy and intubationscheduled for elective surgeries.
Sampling method
SimpleRandomization method.
Statistical analysis
Student unpaired t test.
Method of collection of data
Informed consent will be obtained from the patients.
Comparison groups: patients will be randomly, in a single blind fashion be allocated into Dexmedetomidine group, receiving Dexmedetomidine (1.0g / kg) (group D, n= 50)andEsmolol group receiving Esmolol (1.0mg/kg) (group E, n =50), dilutedto 10 ml with normal saline.
On arrival in the operating room, the patients' baseline heart rate, blood pressure and oxygen saturation (SpO 2) will be recorded after 5 min settling in the operative room. A 20G intravenous cannula will be inserted for drug and continuous fluid administration.
Premedication:intravenous (IV)Glycopyrrolate (0.05mg/kg) midazolam 0.03mg/kg, IV Fentanyl (2g/kg).
Prior induction: Dexmedetomidine (1.0g / kg) in group D over 10 min,or Esmolol (1.0mg/kg) in group E over 60 seconds.
Induction of anesthesia:Inhalational induction with Sevoflurane (titrated till loss of verbal response), and IV Vecuronium0.1mg/kg.
Patient will be ventilated for at least 3min using 100% oxygen. Laryngoscopy using Macintosh laryngoscope and appropriate sized cuffed endotracheal intubation will be done.
Maintenance agents:Oxygen andNitrous oxide in 60:40, Isoflurane/sevoflurane and Vecuronium.
Reversal at the end of surgery: IV Neostigmine 0.04mg/kg and Glycopyrrolate 0.02mg/kg.
Methods of measurement: Record of heart rate through ECG, systolic blood pressure, diastolic blood pressure, mean arterial pressure NIBP in mm/Hg, , rate pressure product calculated by formula (SBPX HR)/1000, SpO2 using pulse oximeter, continuous ECG monitoring, recorded before and 2 min after administration of drug,1min after induction and at 1, 3, 5 and 10 min after intubation.
End point classification: Effectiveness study
7.3 / Does the study require investigations or interventions to be conducted on patients or other human or animal?
Study type: Interventional
Administration of IVDexmedetomidine 1g/kg or IVEsmolol 1mg/kg and recording of the heart rate through ECG, systolic blood pressure, diastolic blood pressure, mean arterial pressure through NIBP in mm/Hg, SpO2 using pulse oximeter and continuous ECG monitoring. Rate pressure product calculated by formula (SBPX HR)/1000.
7.4 / Has ethical clearance been obtained from institute?
Yes
8 / List of References
  1. King BD, Harris LC, Griefenstein FE, Elder JD, and Dripps RD. Reflex Circulatory Responses to Direct Laryngoscopy and Tracheal Intubation Performed during General Anesthesia.Journal of the American society of anesthesiologists1951; 12: 556-66.
  1. Keniya VM, Ladi S, Naphade R. Dexmeditomidine attenuates sympathoadrenal response to tracheal intubation and reduces perioperative anesthetic requirement.Indian J Anesth2011;55:352-7.
  1. Jaakola ML, Ali-Malkkila T, Kanto J, Kallio A, Scheinin H, Scheinin M. Dexmeditomidine reduces intraocular pressure, intubation response and anesthetic requirement in patients undergoing ophthalmic surgery.Br Journal of Anesth1992; 68: 570-5.

4.Bensky KP, Donahue-Spencer L, Hertz GE, AndersonMT, James R. The dose related effects of bolus dose of esmolol and heart rate and blood pressure following laryngoscopy and tracheal intubation. Anesth Analg J 2000; 68:437-42.

5.Belgin Yavascaoglu, FN Kaya, M Bozkurt, S Korkmaz, M Baykara.A comparison of esmolol and dexmeditomidine for attenuation of intraocular pressure and hemodynamic responses to laryngoscopy and tracheal intubation EurJ Anesthesiol2008; 25:508-524.

9. / Signature of the candidate
10. / Remarks of the guide
11. / Name and designation
11.1 / Guide / Dr S Y Hulkund
Professor
Department of Anesthesiology
S.N.MedicalCollege
Bagalkot
11.2 / Signature
11.3 / Co-guide (if any) / Dr Vinod Hosalli
Associate professor
Department of anesthesiology
S.N.MedicalCollege
Bagalkot
11.4 / Signature
11.5 / Head of department / Dr Prakashappa D S
Professor and Head
Department of Anesthesiology
S.N.MedicalCollege
Bagalkot
11.6 / Signature
12 / 12.1 / Remarks of the chairman and principal
12.2 / signature

ANNEXURE- I

RESEARCH INFORMED CONSENT FORM

Study title: a comparative study between intravenous Dexmedetomidine and Esmolol in attenuation of cardiovascular response to laryngoscopy and intubation- A Randomized clinical trial.

Chief researcher/ PG guide’s name: Dr S Y Hulkund

Principal investigator: Dr Navya C N

Name of the subject:

Age :

Gender :

  1. I have been informed in my own language that this study requires administration of a drug and thoroughly understand its complication and possible side effects.
  2. I understand that my participation in the study may not have direct benefit to me.
  3. I understand that the medical information produced by this study will become part of institutional record and will be kept confidential by the said institute.
  4. I understand that my participation is voluntary and may refuse to participate or may withdraw my consent and discontinue participation at any time without prejudice to my present or future care at this institution.
  5. I agree not to restrict the use of any data or results that arise from this study provided such a use is only for scientific purpose(s).
  6. I confirm that ______(chief researcher/ name of PG guide) has explained to me the purpose of research and the study procedure that I will undergo and the possible risks and discomforts as well as benefits that I may experience, in my own language. I hereby agree to give valid consent to participate as a subject in this research project.

Participant’s signature

Signature of the witness: Date:

I have explained to ______(subject) the purpose of the research, the possible risk and benefits to the best of my ability.

Chief Researcher/ Guide signature Date:

CASE RECORD FORM

Case No: Date:

Name of patient

Age: IPD No.

Sex:Wt:

Dept:ASA grade:

Unit:

Diagnosis:

Planned Operation: Operation Performed:

Hours of Fasting Solids Liquids

Consent

Pre anesthetic evaluation

History:

G.C:Pulse:/ minBP:mmHgRS

CVS: CNS

Airway Spine

Pre-op: Investigations.

Hb:gm%TLC:%cu. mmDLC

LFT RFT ECGChest X-ray

Premedication: IV Glycopyrrolate (0.005mg/kg):

IV midazolam 0.03mg/kg:

IV Fentanyl (2g/kg)

Study drug : IV Dexmedetomidine in group D

IV Esmolol in group E

Time of injection of drug under study:

Induction of anesthesia: Sevoflurane+ IV Vecuronium 0.1mg/kg:

Time / Heart rate / Systolic BP / Diastolic BP / Mean Arterial Pressure / Rate pressure product( SBPx HR)/1000 / SpO2 / Adverse events
Base line
2min after administering drug
1min after induction
1 min after intubation
3min after intubation
5 min after intubation
10 min after intubation

Remarks

Signature of the concerned anesthesiologist:

Date :

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