Submitted by:Amarjeet Singh

Ankush RoyAshitha VS

Koushik RakshitNamita PandeyRoma Agrawal

A Comparative Study On Ketamine, Clonidine & A Combination Of Ketamine-clonidine for the Prevention Of Shivering Following General Anesthesia

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 No of Patients: 120

Objective

  GROUP K GROUP C GROUP KC GROUP P

DESC receive ketamine only

receive clonidine only

receive both ketamine & clonidine

receive placebo

SAMPLE SIZE 30 30 30 30

Background

• Types of Variables:1. Continuous: SL, AGE, HEIGHT, WEIGHT, HR, SBP, DBP, MAP, SPO2,

ETCO2, ST, CT2. Categorical: GR, SEX, SURGERY, N_V, SED_SCORE, SHIVERING, DOS,

TACH, BRAD, HYPER, HYPO (these 4 created by us)

• Intra-operative and Post-operative comparison between the groups (ANOVA test)

-continuous variables are compared with categorical variable GR

- H0: µk = µc = µkc = µP

• Comparison with Baseline Value (Intra-operative and Post-operative) (Paired t-test)

- mean difference is calculated for continuous variables with their baseline value- H0: mean difference is 0 i.e. for ex - µHR_5 = µHR_PREOP likewise.

• Adverse effects (chi square test)

- all categorical variables are compared with categorical variable GR- H0: two categorical variables are independent. i.e. it assumes that observed data is distributed as per the expectation that variables are independent.

Analysis and Observations

Demographics

• Groups are statistically same on the basis of average age, height, weight, duration of surgery and male-female ratio.

Intra-Operative Comparison

• Group C, which has been given clonidine, is lowering the heart rate while other 3 groups have more or less similar heart rate near normal range.

 • Group C is better among the four as it keeps the systolic blood pressure near the

normal range while others (ketamine, ketamine and clonidine and placebo) increases the SBP among the patients of the respective groups. Max at end of surgery which is 150+ 

 

• Diastolic blood pressure (DBP) is within ideal range for Group C, KC and P. Ketamine slightly raises DBP, reaching a maximum of 82.9.

• Ketamine is raising the MAP of patients in group K which is not good for them. Also group K and P patients have values maximum at end of surgery.

• Drugs have no effects on SPO2, ETCO2, ST, and CT. All these remain same for all groups.

Post-Operative Comparison

• HR of all patients in Group K, KC and P are absolutely normal, but Group C has decreased too much.

• Systolic blood pressure (SBP) is higher than the normal range i.e. <=120. Group C, KC and P are better, but group K patients’ needs attention.

• Diastolic blood pressure (DBP) is low for patients in group C and KC, other two are absolutely fine.

• Ketamine is raising the MAP of patients in group K, which is not good for them. Also group P patients have values towards the higher end of range. Group C and KC patients have normal MAP.

• Drugs have no effects on SPO2, it remain same for all groups.

Comparison with Baseline values (pre-operative) during Intra-Operative Period

• Ketamine is raising the HR and clonidine is lowering the HR significantly from its baseline value.

• Clonidine is decreasing the SBP significantly from its baseline value.

• Ketamine is raising the DBP and MAP and clonidine is lowering both the pressures significantly from its baseline value.

  • SPO2 remains same across all four groups. • All the four groups have patients with increased ST compared to baseline

values. Changes in ST are considerable in all the groups.

Comparison with Baseline values (end of surgery) during Post operative

• HR, SBP, DBP and MAP has decreased from its pre-operative value. HR is decreasing to gain stabilization. So this is good that patients are tending towards normal values.

   • SPO2 remains same across all four groups.

 

• As Ketamine makes Heart rate and Mean Arterial Pressure raise during Intra operative period which is the cause for maximum patients of this group suffering from Tachycardia and hypertension.

 • Similarly, clonidine is lowering down the Heart rate and Mean Arterial Pressure

that’s why patients of group C are suffering from Bradycardia, Hypotension. 

Adverse Effects Comparison

• Nausea Vomiting are seen maximum within group C patients.

• Group KC has almost equally distributed patients among all 5 side-effects.

• Almost 80 - 84% patients in Group K and P are having low sedation score which is good (Sed_score >=3 is not good for patients). Group C, which has been given clonidine, has maximum sedation score. Group P has received saline and has lowest sedation score (83.33% has Sed_score of 1).

• All the group’s patients have shivering. Maximum in group P followed by K. Group P was given saline and 66.67% are having post anesthetic shivering. Group KC has minimum shivering (50% patients are not shivering).

Conclusion

Group KC has lesser variation of parameters among all 4 groups, therefore it is clear that patients within group KC (who were given a dose of combination of intravenous ketamine (0.25mg/kg) and clonidine (0.75mcg/kg)) are getting better treatment.

Also the adverse effects are normally distributed and less in comparison with other 3 groups.

Best among the four in case of post-anesthetic shivering. Should work on the following side-effects:• Tachycardia and Hypertension in group K • Bradycardia, Hypotension and Nausea Vomiting in group C• Group P does not have sedation but have maximum shivering among four

groups.

Thank you!