NCT05786365

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 108 (actual)
• Sponsor: Aksaray University Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Sedation Complication

Interventions

Type	Name	Description
DRUG	Ketalar 50 MG/ML Injectable Solution	Ketamine will be administered to two different groups as 0.5 mg/kg and 1 mg/kg

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-09-15
• Completion: 2023-12-31
• First posted: 2023-03-27
• Last updated: 2024-07-30

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated drug study