Comparative Medical Case Study Of drugs

1. A COMPARATIVE
STUDY ON KETAMINE,
CLONIDINE & A
COMBINATION OF
KETAMINE-CLONIDINE
FOR PREVENTION OF
SHIVERING
FOLLOWING GENERAL
ANAESTHESIA
Presented by:
Amarjeet Singh
Ankush Roy
Ashitha VS
Koushik Rakshit
Namita Pandey
Roma Agrawal

2. BACKGROUND
OBJECTIVE OF THE STUDY
 To compare the efficacy of single dose intravenous ketamine
(0.5mg/kg) and intravenous clonidine (1.5mcg/kg) and combination
of intravenous ketamine(0.25mg/kg) plus clonidine(0.75mcg/kg) in
the prevention of shivering following general anesthesia.
Total Size of Sample: 120 patients
Randomly allocated in following four equal groups:
 Group K – will receive intravenous ketamine(0.5mg/kg).
 Group C - will receive intravenous clonidine(1.5mcg/kg).
 Group KC– will receive combination of intravenous
ketamine(0.25mg/kg) and intravenous clonidine(0.75mcg/kg).
 Group P - will receive intravenous normal saline(placebo).

3. ANALYSIS & OBSERVATIONS
 Average Age, Weight & Height are symmetrical across
all groups.
 Average duration of surgery is also similar across all
groups.
 Each group has a similar sex ratio.
 Hence, we can infer that all the four groups are identical
in nature.

4. ANALYSIS & OBSERVATIONS
Intra Operative Comparison
Heart Rate (HR) across Groups: Pre operative HR was same across
all the groups. After that, as p<0.0001 at every time stamp, HR is
fluctuating. Group C has exceptionally low HR.

5. ANALYSIS & OBSERVATIONS
Intra Operative Comparison
Systolic Blood Pressure (SBP) across Groups: Pre operative value is
same, after that values are different across the groups at different time
stamps and exceptionally low for Group C.

6. ANALYSIS & OBSERVATIONS
Intra Operative Comparison
Diastolic Blood Pressure (DBP) across Groups: Mean DBP, just like
HR and SBP, has showed similar pattern in all the groups. However,
DBP for group C is relatively lower as compared to other groups. Mean
DBP across groups are the same for all the groups at pre-op stage.

7. ANALYSIS & OBSERVATIONS
Intra Operative Comparison
Mean Arterial Pressure (MAP) across Groups: MAP also follows the
same pattern - same for groups K, KC and P and slightly lower for
group C.

8. ANALYSIS & OBSERVATIONS
Intra Operative Comparison
Peripheral Oxygen Saturation (SPO2) across Groups: As p-value is
significantly high at every time stamps, therefore, null hypothesis is
true, hence there is symmetry between all four groups with reference
to SPO2.

9. ANALYSIS & OBSERVATIONS
Intra Operative Comparison
Capnography (ETCO2) across Groups: All 4 groups have similar type
of fluctuations and mean ETCO2 is almost same across groups at all
time stamps.

10. ANALYSIS & OBSERVATIONS
Intra Operative Comparison
Surface Temperature (ST) across Groups: Mean ST is similar across
all four groups.

11. ANALYSIS & OBSERVATIONS
Intra Operative Comparison
Core Temperature (CT) across Groups: Mean CT remain same across
all groups. Variations in first 3 groups are same, but group P has
constant CT.

12. ANALYSIS & OBSERVATIONS
Post Operative Comparison
Heart Rate (HR) across Groups: It is similar in Groups K, KC, P but
slightly low in group C.

13. ANALYSIS & OBSERVATIONS
Post Operative Comparison
Systolic Blood Pressure (SBP) across Groups: It is similar in Groups K,
KC, P but slightly low in group C.

14. ANALYSIS & OBSERVATIONS
Post Operative Comparison
Diastolic Blood Pressure (DBP) across Groups: It is similar in Groups
K, KC, P but slightly low in group C.

15. ANALYSIS & OBSERVATIONS
Post Operative Comparison
Mean Arterial Pressure (MAP) across Groups across Groups: It is
similar in Groups K, KC, P but slightly low in group C.

16. ANALYSIS & OBSERVATIONS
Post Operative Comparison
Peripheral Oxygen Saturation (SPO2) across Groups: As p-value is
high, therefore, all 4 groups have similar values of SPO2.

17. ANALYSIS & OBSERVATIONS
Comparison with Baseline values (Intra-Operative)
 Heart Rate (baseline value is HR_PREOP): Behaviors of
Group K and C are same, where p-value is significantly less.
Therefore null hypothesis is rejected and, hence, HR for these
two groups are different at different time points. Groups KC
and P have P>0.5 at most of the time stamp. Hence, for these
two groups null hypothesis is accepted. Thus, they have same
HR at different time points.
 Peripheral Oxygen Saturation (SPO2) (baseline values is
SPO2_PI): P-value is significantly high for all 4 groups. The
null hypothesis is accepted and, hence, SPO2 is same across
all groups.

18. ANALYSIS & OBSERVATIONS
Comparison with Baseline values (Intra-Operative)
 Systolic Blood Pressure, Diastolic Blood Pressure and
Mean Arterial Pressure (baseline value is SBP_PREOP,
DBP_PREOP and MAP_PREOP respectively):
Behaviors of Group K and C are same, P value is
significantly less. Therefore, null hypothesis is rejected
and, hence, these 3 variables for these two groups are
different at different time points. Groups K,C and P have
P>0.5 at most of the time stamp. Hence, for these two
groups null hypothesis is accepted. Thus, they have
same SBP, DBP and MAP at different time points.

19. ANALYSIS & OBSERVATIONS
Comparison with Baseline values (Post-Operative)
 Heart Rate (baseline value is HR_EOS): P<0. Thus,
alternative hypothesis accepted, i.e., all groups have different
HR at different time interval.
 Systolic Blood Pressure, Diastolic Blood Pressure and Mean
Arterial Pressure (baseline value is SBP_EOS, DBP_EOS
and MAP_EOS respectively): P<0. Therefore, alternative
hypothesis is accepted, i.e., all groups have different SBP,
DBP and MAP at different time interval.
 Peripheral Oxygen Saturation (SPO2) (baseline value is
SPO2_EOS): SPO2 is stable as p is significantly high. Null
hypothesis is true.

20. ANALYSIS & OBSERVATIONS
• Group K has highest cases of Tachycardia and Hypertension in
group K while Bradycardia.
• Hypotension and Nausea Vomiting are mainly reported within group
C patients.
• Group KC has lesser side-affects among all 4 groups

21. ANALYSIS & OBSERVATIONS
 Maximum patients from Group K suffered both from
Tachycardia & Hypertension immediately followed by Group
P in both the cases.
 No case of hypertension reported in Group C.
 Group C reported with highest cases of Hypotension while
no cases is seen in Group K.
 Affect of nausea & vomiting is highest in Group C with 8
patients.
 Interestingly, Group KC has lesser side-affects among all 4
groups.

22. ANALYSIS & OBSERVATIONS
Sedation is the most in group C , followed by group KC. Almost
80-85% patients of group K & P, remain fully awake, which is a
serious issue during operation.

23. ANALYSIS & OBSERVATIONS
Shivering was more or less noticed amongst all groups but
maximum in group P followed by K and KC.
.

24. RECOMMENDATIONS
From the analysis, it is clear that patients who were given dose
of combination of intravenous ketamine (0.25mg/kg) and
clonidine (0.75mcg/kg)) have normal variation for almost all
parameters and also less side-effects.
So, this will be the best way for the prevention of Post-anesthetic
Shivering.
Scope for further medical research
Causes for side-effects should be determined:
 Tachycardia and hypertension in group K
 Bradycardia, Hypotension and Nausea Vomiting in group C

25. Thank You