A COMPARISON BETWEEN KETAMINE,CLONIDINE AND COMBINATION OF KETAMINE-CLONIDINE FOR THE PREVENTION OF POSTANAESTHETIC SHIVERING

Presented byAsim AbinashKrishna BollojulaShubham SharmaSoham MukhopadhyaySuddhasheel BhattacharyaSwapnasis Mohanty

Agenda

• Introduction• Objective• Demographical Analysis• Intra-operative Analysis• Post-operative Analysis• Adverse Effects• Final Results• Conclusion

Introduction

• Data Given Sample Size (120 Patients)

• Groups(4) Group-K(Single dose of Intravenous Ketamine [0.5mg/kg]) Group-C(Single dose of Intravenous Clonidine [1.5mg/kg]) Group-KC(Combination of Intravenous Ketamine

[0.25mg/kg] and Clonidine [o.75mcg/kg]) Group-P(Placebo)

Objective

To compare the efficacy of single dose intravenous ketamine and intravenous clonidine and combination of intravenous ketamine plus clonidine in the prevention of shivering following general anesthesia.

Total Sample Size(120)

Group-K(30) Group-C(30) Group-KC(30) Group-P(30)

Demographic Analysis

• Average age, height, weight and duration of surgery are almost same across groups.

• Male-female ratio in Group-P is almost same.

Intra-operative and Post-operative Analysis

• Across groups, the average values of Heart Rate(HR), Systolic Blood Pressure(SBP), Diastolic Blood Pressure(DBP), Mean Arterial Pressure(MAP),Peripheral oxygen saturation (SPO2) are compared using ANOVA test.

• Across groups, the mean difference values of all the above variables are compared with the baseline value using Paired t-test.

• These variables are tested using the values measured during intra-operative and post-operative periods.

• Body temperatures(Core and Surface) and Capnography (ETCO2 ) are measured only during Intra-operative periods.

Intra-operative Analysis

• Heart Rate(HR) has shown variations across all groups after induction. Group-C has shown the highest variation.

• When compared with base line value, Group-K is raising the HR, Group-C is lowering the HR and Group-KC has fewer variations and more stability.

• Systolic Blood Pressure(SBP) has shown variations across all groups. Group-KC has shown the less variations (values lies between 120-139 with less fluctuations).

• When compared with base line value, Group-KC is more stable and there is a sudden increase at EOS in Group-K and Group-P

Intra-operative Analysis

• Diastolic Blood Pressure(DBP) is stable across Group-C, Group-KC and Group-P and near to normal value of being less than 80. Group-K is slightly increasing DBP.

• When compared from baseline, Group-K and Group-C has high fluctuations, Group-P seems more stable at all intervals except at 15 min and EOS intervals. Group-KC is more stable.

• Mean Arterial Pressure shows variations across groups with highest variation in Group-C and more stable in Group-KC.

• When compared from baseline, SBP is increasing in Group-K and decreasing in Group-C and more stable in Group-KC.

Intra-operative Analysis

• Peripheral oxygen saturation (SPO2 ) has very less fluctuations and almost similar across groups.

• When compared from baseline, it seems same across groups and values at 50 min and 30 min in Group-KC and Group-P are the same values as the baseline(mean difference=0).

• Capnography (ETCO2 ) has very less fluctuations and almost similar across groups.

• When compared from baseline, it seems same across groups. However, Group-KC is decreasing very slightly from baseline, Group-P is increasing from baseline.

Intra-operative Analysis

• Core temperature has very less fluctuations and almost similar across groups.

• When compared from base line, it shows variations in Group-K, C and KC except at Induction interval and Group-P don’t have any variations.

• Surface temperature has very less fluctuations and almost similar across groups.

• When compared from baseline, it shows variations in all groups except in three intervals in Group-P.

Post-operative Analysis

• Heart Rate(HR) is more stable across all groups except Group-C has shown decrease in HR.

• When compared with base line value(EOS), all groups patients HR is coming to normal values.

• Systolic Blood Pressure(SBP) has shown variations by being higher the normal value(120-139) across all groups except Group-C. Group-K has shown higher variations.

• When compared with base line value, all groups have shown variations, Group-K, C and P values are decreasing.

Post-operative Analysis

• Diastolic Blood Pressure(DBP) is stable across Group-K, Group-KC and Group-P and near to normal value of being less than 80. Group-C DBP values are decreasing.

• When compared from baseline, all groups DBP values are getting decreased. Hence, Group-C patients need attention.

• Mean Arterial Pressure shows variations across groups with highest variation in Group-C and Group-KC.

• When compared from baseline, MAP values in all groups are decreasing and very high variation at 30 min.

Post-operative Analysis

• Peripheral oxygen saturation (SPO2 ) has very less fluctuations and almost similar across groups.

• When compared from baseline, it seems same across groups and values at 30 min in Group-KC is the same values as the baseline(mean difference=0).

Adverse Effects

• Tachycardia (Intra-op HR >100)

60% of people have tachycardia in Group- K 80% of people do not have tachycardia in Group-C &

Group-KC More than 65% of people do not have tachycardia in

Group-C• Bradycardia (Intra-op HR <60)

50% of people have bradycardia in Group-C More than 90% of people have no event of

bradycardia in Group-K More than 85% of people have no event of

bradycardia in Group-KC and Group-P

Adverse Effects

• Hypertension (Intra-op MAP > 20%or more from Baseline)

50% of people in Group-K has hypertension Group- C has no event of hypertension 47% of people in Group-P has hypertension In Group-KC has more than 85% event of no

hypertension• Hypotension (Intra-op MAP < 20%or more from Baseline)

Group – K has no event of hypotension 50% of people in Group – P has hypotension Group-KC and Group –P has 17% event of

hypotension

Adverse Effects

• Nausea and Vomiting 90 % of the people in Group-K, Group-P & Group-KC

has no event of nausea and vomiting. Group-C has highest events of nausea and vomiting.

• Shivering 50 % of the people in Group KC has no Shivering. Group P has highest event of Shivering(Shiv>=3). Group K & Group C has shivering levels between 1 and 2.

Adverse Effects

• Sedation Score High Variation of sedation Score in Group C

(sed_score>=3). More than 80% of people in Group K & Group P has

score of 1. More than 50% of people in Group KC has score of 1. General Sedation Score scale.

Adverse Effects

Final Results

Parameters Group-K Group-K Group-K&C Group-P

Pre-operative

Heart rate NE NE E NESystolic BP NE NE E NEDiastolic BP NE NE E NEMean Artrial pressure NE NE E NE

Post operative

Heart rate NE NE NE NESystolic BP NE E NE NEDiastolic BP NE NE NE NEMean Artrial pressure NE NE NE NE

If there is less number of fluctuations from Base Line we have termed it as effective for that parcticular parameterIf there is high number of fluctuations from Base Line we have termed it as Not effective for that parcticular parameter

Final Results

Variables Group-K Group-C Group-KC Group-PSHIVERING NORMAL NORMAL LOWEST HIGHESTSEDATION LOWEST HIGHEST NORMAL LOWESTHYPOTENSION LOWEST HIGHEST NORMAL NORMALHYPERTENSION HIGHEST LOWEST NORMAL HIGHESTBRADYCARDIA NORMAL HIGHEST NORMAL NORMALTACHYCARDIA HIGHEST NORMAL NORMAL NORMALNAUSEA & VOMITING LOWEST HIGHEST NORMAL NORMAL

SHIVERING HYPERTENSIONLOWEST LOWEST SHIVERING SCORE ACROSS GROUPS LOWEST LOWEST SHIVERING SCORE ACROSS GROUPSHIGHEST HIGHEST SHIVERING SCORE ACROSS GROUPS HIGHEST HIGHEST SHIVERING SCORE ACROSS GROUPSNORMAL ALL VALS IN BETWEEN NORMAL ALL VALS IN BETWEEN

SEDATION TACHYCARDIALOWEST LOWEST SED SCORE ACROSS GROUPS LOWEST LOWEST SED SCORE ACROSS GROUPSHIGHEST HIGHEST SED SCORE ACROSS GROUPS HIGHEST HIGHEST SED SCORE ACROSS GROUPSNORMAL ALL VALS IN BETWEEN NORMAL ALL VALS IN BETWEEN

HYPOTENSION BRADYCHARDIALOWEST LOWEST HYPOTENSION ACROSS GROUPS LOWEST LOWEST HYPOTENSION ACROSS GROUPSHIGHEST HIGHEST HYPOTENSION ACROSS GROUPS HIGHEST HIGHEST HYPOTENSION ACROSS GROUPSNORMAL ALL VALS IN BETWEEN NORMAL ALL VALS IN BETWEEN

Conclusion

Based on the comparisons of vital parameters and adverse effects across all groups, we conclude that

Intravenous ketamine (0.25mg/kg) and clonidine (0.75mcg/kg)) combination works the best for most vital parameters with least adverse effects.

•We need to check with the other adverse effects like sedation score, shivering, tachycardia etc., caused to patients due to this drug.