1. Dissertation Proposal
Presented by
Dr. Shreya Modi
Under Guidance of
Dr. Subhash K. Patel
Associate Professor,
Department Of Anaesthesiology,
SMIMER, Surat.
2. TOPIC OF DISSERTATION
“A COMPARATIVE STUDY OF DEXMEDETOMIDINE AND
CLONIDINE AS AN ADJUVANT TO ISOBARIC
ROPIVACAINE 0.75% IN SPINAL ANAESTHESIA IN
LOWER LIMB AND LOWER ABDOMINAL SURGERIES.”
3. Subject Key Words:
•SPINAL Anaesthesia
•0.75 %Ropivacaine
•Clonidine and Dexmedetomidine
•Lower Limb and Lower Abdominal Surgeries
4. Introduction:
Spinal anesthesia is a popular modality for lower
abdominal and lower limb surgery. As procedure is very
simple, quicker onset of action, it is trustworthy in
generating generalized sensory & motor blockade.
5. Introduction:
•Due to its shorter duration of action, it has no long lasting
postoperative analgesia. To solve this problem ,
administration of local anaesthetic with various types of
adjuvant is a fair method which provides early
commencement and prolonged duration of sensory and
motor block in spinal anaesthesia. So it act as synergistic to
local anaesthetic with lower local anaesthetic requirement,
reduce side effects & excellent postoperative analgesia.
6. Research Question :
1.Onset of sensory and motor block.
2.Duration of sensory and motor block.
3.Hemodynamic changes
7. Aims :
To evaluate the effect of ISOBARIC
ROPIVACAINE 0.75% WITH
DEXMEDETOMIDINE AND CLONIDINE as an
ADJUVANT in SPINAL Anaesthesia in lower limb
and lower abdominal surgeries.
8. Objective :
●Onset Of sensory and motor block.
●Duration of sensory and motor block.
●Duration of analgesia and Rescue Analgesia.
●Haemodynamic changes like heart rate and blood pressure.
●Side effects and complications (if any).
10. Study Type & Sample Size:
●Observational study,
●Sample size (n=35 cases per each group) is calculated by using Open
EPI softwares by using demographic Mean weight part. (GROUP C –
mean 64.4 with SD 6.86 and GROUP D 68.3 with SD 5.4) based on
reference “ A comparative study on effects of intrathecal ropivacaine
plus dexmedetomidine versus ropivacaine plus clonidine “ by K. K.
Arora , bilaspur.
●Power = 80%
●Confidence Interval = 95
●Sample size = 70(n1=35, n2=35)
11. Sampling Technique:
●Patients will be selected by randomization by SPSS
(Statistical package for the social sciences) software.
(Simple random sampling).
12. Methodology:
●After approval From the Institutional Ethical committee and
informed written consent from patients, this prospective,
randomized, study will be carried out.
● 70 patients aged 18-60 years of either sex , height , weight ,
ASA status I and II scheduled for elective lower abdominal
and lower limb surgeries will be enrolled in this study.
13. Methodology:
●INCLUSION CRITERIA:
1) Patients in the age range 18-60 years.
2) ASA risk category I and II.
3) No known history of allergy.
4) Patient willing to sign informed consent.
14. Methodology:
●EXCLUSION CRITERIA:
1) Patient’s refusal.
2) Patients on antiplatelets, or on anticoagulants therapy.
3) Patients with local skin infections at site of injection.
4) Pschycological disorders/Neuropsychiatric disorders.
15. ●All the patients will be subjected to detailed pre-anaesthetic evaluation
with clinical history, General and Systemic examination of RS, CVS,
CNS & ALIMENTARY SYSTEM.
●Routine investigations like Haemogram, Random Blood Sugar, Renal
Profile, X ray chest (PA view) and ECG for patients should be done.
16. OT preparations:
Anaesthesia machine with working laryngoscope, airway,
endotracheal tubes, facemask and Bain’s circuit.
●Multiparamonitor
●ECG electrodes
●A sterile tray containing:
Sterile swab holding forceps
Adequate cotton swabs
Povidone-iodine and spirit
Sterile towel
Disposable 25 G SPINAL NEEDLE
10 ml syringe
Study drugs
17. Patient preparations:
●All patients will be kept nil by mouth for at least 6 hours before
surgery.
●An intravenous line will be secured with an intravenous
cannula.(Preloading will be carried out by infusion of lactated Ringer’s
solution (10 ml/kg).
●Pulse oximeter, non-invasive blood pressure cuff and ECG
electrodes will be attached and baseline pulse, blood pressure,
oxygen saturation will be recorded.
Premedication :
Inj. Glycopyrrolate 0.005 mg/kg IV.
Inj. Ondansetron 0.1 mg/kg IV.
18. Group C(n=35) will receive Isobaric Inj. Ropivacaine 0.75% 3.2 ml +
Inj.Clonidine 30 µgm intrathecally.
Group D(n=35) will receive Isobaric Inj. Ropivacaine 0.75% 3.2ml +
Inj.Dexmedetomidine 5 µgm intrathecally with 0.1ml N.S.
19. The Following parameters will be observed &
compared.
1)Onset of sensory and motor block.
2)Duration of sensory and motor block.
3)Haemodynamic changes during intra & post operatively.
4)Duration of analgesia and Rescue Analgesia.
5)Side effects and complications during intra & post-operative.
20. Intra-operative period:
Pulse rate, Blood pressure, Oxygen saturation and level of
sedation will monitored, immediately after giving the block, 5
min, 10 min, 15 min, then every 15 min up to 60 min, then every
30 min up to completion of surgery in intra-operative periods.
22. Side effects:
Patients will be observed for any cardiovascular or central nervous
toxicity by changes in hemodynamic or signs of CNS stimulation:
Hypotension- Fall in blood pressure of more than 20% of pre-operative
value.
Bradycardia- Fall in pulse rate less than 60/min.
Nausea and vomiting
Respiratory depression- Fall in Spo2 less than 90% or respiratory rate
less than10/min
Hypersensitivity
Local anaesthetic toxicity response to stimulation
23. Post-operative period:
Post-operatively pulse rate, blood pressure, Spo2, level of
sedation, effect of sensory & motor block and post-operative
analgesia (VAS score) will be monitored every hourly up to 4
hours, then every 2 hourly up to 12 hours, then every 3 hourly up
to 18 hours and then at 24 hours.
24. ●Project setting: Tertiary care teaching hospital in Surat, Gujarat.
●Location: Department of Anaesthesiology, SMIMER, Surat.
●Period of patient recruitment: 12-18 months
26. Benefits Of Study:
●Both significantly shortens the time of onset.
●Better postoperative outcomes.
●haemodynamic parameters and SpO2 will be compared.
●Minimal sedation & Visual Analog Scale score with no significant side
effects/complications
27. EXPECTED RESULTS & CONCLUSION:
●Supplementation of 5µg Dexmedetomidine with 3.2ml of 0.75%
Ropivacaine in spinal, significantly shortens the time of onset and
prolonged the duration of sensory and motor blockade as compared to
intrathecal 0.75% Ropivacaine with 30µg of clonidine.
28. REFERENCES
●Kristina S. Kuusniemi, Kalevi K. Pihlajama¨ ki, Mikko T. Pitka¨ nen,
Hans Y. Helenius and Olli A. Kirvela. The Use of Bupivacaine and
Fentanyl for SpinalAnesthesia for Urologic Surgery. Anaesth Analg
2000;91:1452–6
●Agrawal Nidhi, Usmani A, Sehgal R, Kumar Rakesh, Bhadoria Poonam.
Effectof intrathecal Midazolam Bupivacaine combination on
postoperative analgesia. IJA 2005; 49: 37-79.
●M Edwards, JM Serrao, JP Gent, CS Goodchill. GABA involvement in
spinal analgesia with Midazolam. BJA: 1989; 62: 233-34.
●Subhi M. Al-Ghanem, Islam M. massad, Mohamoud M. Al-Mustafa,
khaled R. Al- Zaben, Ibrahim Y Qudaisat, Ayman m Qatanweh et
al.Effect of adding Dexmedetomidine versus Fentanyl to Intrathecal
Bupivacaine on spinal block characteristics in gynecological procedures:
A double blind controlled study. American journal of applied sciences
2009; 6:882-87
29. ●M Edwards, JM Serrao, JP Gent, CS Goodchill. GABA involvement in
spinal analgesia with Midazolam. BJA: 1989; 62: 233-34.
●Murali Krishna T,Panda NB,Batra YK,Rajeev S.:combination of low
doses of intrathecal Ketamine and Midazolam with Bupivacaine
improves postoperative analgesia in orthopaedic surgeries.Eur J
Anaesthesiol. 2008; 25:299-306. Bibliography
30. PROFORMA
●A COMPARATIVE STUDY OF DEXMEDETOMIDINE AND
CLONIDINE AS AN ADJUVANT TO ISOBARIC ROPIVACAINE
0.75% IN SPINAL ANAESTHESIA IN LOWER LIMB AND LOWER
ABDOMINAL SURGERIES.
●Inclusion criteria:
●Patients belonging to ASA grade I, II.
●Patients of either sex, between the age group 18 to 60 years.
●Elective surgeries which are less than equal to 2 hours.
●Patients who will give a written informed consent.
●Exclusion criteria:
●Patient’s refusal.
●Patients on antiplatelets, or on anticoagulants therapy
●Patients with local skin infections at site of injection
31.
32.
33. ●Written informed consent will be taken.
●NBM status:
●IV access: Secure large vein with appropriate size cannula. Pre
medication:1. Inj. Glycopyrrolate 0.005 mg/kg IV.
● 2. Inj. Ondansetron 0.1 mg/kg IV.
●Preloading will be carried out by infusion of lactated Ringer’ssolution (10
ml/kg)
●1. In Group C, will receive Inj. Ropivacaine Isobaric 0.75% 3.2 ml +
Inj.Clonidine 30µgm intrathecally.
●2. In Group D, will receive Inj. Ropivacaine Isobaric 0.75% 3.2 ml +
Inj.Dexmedetomidine 5µgm intrathecally .
34. ●FOLLOWING WILL BE OBSERVED:
●1. Onset of sensory and motor block.
●2. Duration of sensory and motor block.
●3. Haemodynamic changes during intra & post operatively.
●4. Duration of analgesia and Rescue Analgesia.
●5. Side effects and complications during intra & post-operatively.
