Comparison of Emergence/Dysphoric Reaction Frequency of Using 2 Different Doses Ketamine

Study Overview
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Brief Summary
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The aim of this study is to compare the effect of using different doses of ketamine on producing dysphoric reaction.

Detailed Description
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Our study is a randomized single-blind observational study. In our study, the effect of producing a dysphoric reaction will be observed by administering ketamine at doses of 0.5 mg/kg and 1 mg/kg to two randomly randomized different groups who presented to our hospital and needed interventional sedation analgesia. For this reason, our patients with an indication for interventional sedation and analgesia will be taken to the observation room and their vital values will be monitored. Two different vascular accesses with at least 18 gauge will be obtained from the two extremities. The patients will be randomized and 0.5 mg/kg IV ketamine will be given to the 1st group. The second group will be given 1 mg/kg IV ketamine. Then, the patients will be recorded in terms of blood pressure, pulse and saturation at the 5th minute, 15th minute and 30th minute. We will give iv ketamine to two different patient groups as 0.5 mg per kilogram in the 1st group and 1 mg per kilogram in the 2nd group and we will observe the patients.We scored the patients between +4 and -5 points on the RASS scale. Patients who were sedated to an extent that they could not be awakened were scored as -5, patients who were dangerously agitated +4, and patients who were awake were scored 0. We considered patients who scored +2 on the Richmond agitation sedation scale as having developed a dysphoric reaction.

Official Title
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Comparison of Emergence/Dysphoric Reaction Frequency of Using Ketamine at 2 Different Doses in Interventional Sedation and Analgesia

Conditions
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Sedation Complication

Intervention / Treatment
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* Drug: Ketalar 50 MG/ML Injectable Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Glaskow coma scale should be 15 Inability to speak, read or understand English or Turkish Patients needing procedural sedation and analgesia Exclusion Criteria: Patients with active coronary artery disease Patients with liver or kidney transplant Patients with conditions that change consciousness such as substance intake, alcohol intake Patients with advanced COPD or Heart failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The group given 0.5 mg/kg ketamine<br>In this group we will give 0.5 mg/kg ketamine and we observe for disphoric reaction | Drug: Ketalar 50 MG/ML Injectable Solution<br>* Ketamine will be administered to two different groups as 0.5 mg/kg and 1 mg/kg<br>* Other names: ketamine hydrochloride;|
| The group given 1 mg/kg ketamine<br>In this group we will give 1 mg/kg ketamine and we observe for disphoric reaction | Drug: Ketalar 50 MG/ML Injectable Solution<br>* Ketamine will be administered to two different groups as 0.5 mg/kg and 1 mg/kg<br>* Other names: ketamine hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To observe a significant difference between the two doses in terms of producing a dysphoric reaction | We will give iv ketamine to two different patient groups as 0.5 miligram/kilogram in the 1st group and 1 miligram/kilogram in the 2nd group and we will observe the patients.We scored the patients between +4 and -5 points on the Richmond Agitation and Sedation Scale between -5 to +4. Patients who were sedated to an extent that they could not be awakened were scored as -5, patients who were dangerously agitated +4, and patients who were awake were scored 0. We considered patients who scored +2 on the Richmond agitation sedation scale as having developed a dysphoric reaction. | January 2023-August 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of 0.5 mg/kg and 1 mg/kg IV ketamine | We will give iv ketamine to two different patient groups as 0.5 miligram/kilogram in the 1st group and 1 miligram/kilogram in the 2nd group, and and we will evaluate patients in terms of sedation duration and efficacy.We evaluated the efficacy according to whether additional doses were needed, sedation duration, and the ability to perform the procedural procedure. | January 2023-August 2023 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine, Procedural sedation analgesia, Dysphoric reaction, Sedation