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

Aksaray University Training and Research Hospital108 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

108

Conditions

Sedation Complication

Interventions

Ketalar 50 MG/ML Injectable SolutionDRUG

Ketamine will be administered to two different groups as 0.5 mg/kg and 1 mg/kg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Çağrı Türkücü

Aksaray, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

Time frame: January 2023-August 2023

Secondary Outcomes

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.

Time frame: January 2023-August 2023

Data from ClinicalTrials.gov

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