Comparison of Ketamine-propofol Combinations

Study Overview
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Brief Summary
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ASA I-II 3-12 years old children participated to this study. All Participants will divide into the three groups. In Groups I, 2,5 mg/kg propofol and 0,5 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 5/1 ratio of ketamine-propofol mixture with %67 of Mcfarlan dose regiment. In Groups II, 2,75 mg/kg propofol and 0,41 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 6,7/1 ratio of ketamine-propofol mixture with %80 of Mcfarlan dose regiment. In Groups III, 3 mg/kg propofol and 0,3 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 10/1 ratio of ketamine-propofol mixture with %90 of Mcfarlan dose regiment. After than surgical operation recovery time, PAED scores, FLACC scores, Staying time in PACU will be recorded. These data will be evaluated with statistically.

Detailed Description
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ASA I-II, 3-12 years old children who will operate due to tonsillectomy and adenoidectomy. will be participated in to this study. All Participants will divide into the three groups. In Groups I, 2,5 mg/kg propofol and 0,5 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 5/1 ratio of ketamine-propofol mixture with %67 of Mcfarlan dose regiment. In Groups II, 2,75 mg/kg propofol and 0,41 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 6,7/1 ratio of ketamine-propofol mixture with %80 of Mcfarlan dose regiment. In Groups III, 3 mg/kg propofol and 0,3 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 10/1 ratio of ketamine-propofol mixture with %90 of Mcfarlan dose regiment. McFarlan dose regiments include 15 mg/kg/h infusion during 15 minutes, 13 mg/kg/h infusion during second 15 minutes, 11 mg/kg/h infusion from 30 to 60 minutes, 10 mg/kg/h from 1 to 2 h. Anaesthesia dept will be detect with BIS monitoring during operation. After than surgical operation recovery time, PAED scores, FLACC scores, staying time in PACU and extubation time will be record. At the end of the study, these data will be evaluated with statistically.

Official Title
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Effect of Ketamine-propofol Mixture on Postoperative Pain and Sedation-agitation

Conditions
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Agitation, Postoperative Pain

Intervention / Treatment
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* Drug: Ketamine-propofol mixture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II children Children who will be performed to adenoidectomy and tonsillectomy surgical operations Exclusion Criteria: ASA III-IV children Patients over the age of 13

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ketamine-propofol mixture 5/1<br>Ketamine-propofol mixture will be compare for every groups. | Drug: Ketamine-propofol mixture<br>* Ratio of Ketamine-propofol mixture will be compare for every groups.<br>* Other names: ketofol;|
| Active Comparator: ketamine-propofol mixture 10/1<br>Ketamine-propofol mixture will be compare for every groups. | Drug: Ketamine-propofol mixture<br>* Ratio of Ketamine-propofol mixture will be compare for every groups.<br>* Other names: ketofol;|
| Active Comparator: Ketamine-propofol mixture 6,7/1<br>Ketamine-propofol mixture will be compare for every groups | Drug: Ketamine-propofol mixture<br>* Ratio of Ketamine-propofol mixture will be compare for every groups.<br>* Other names: ketofol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAED(Paediatric Anaesthesia Emergence Delirium) Scores Evaluation | All patients will be evaluate with PAED scores at PACU during first 1 hour | During 1 hour at post operative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anaesthesia depth assessed using the Bispectral Index (BIS) | All Patients will monitored with BIS monitoring during operation. | During peroperative period. | 
| Extubation time | At the end of the surgery, time from injection of reversal to extubation | time from injection of reversal to extubation, through patient extubated | 
| FLACC(Face, leg movement, activity, craying, consolability) | All patients will be evaluate with FLACC scores at PACU during first 1 hour | During 1 hour at post operative period |