Clinical trial NCT05786365: Comparison of Emergence/Dysphoric Reaction Frequency of Using 2 Different Doses Ketamine
Official title: Comparison of Emergence/Dysphoric Reaction Frequency of Using Ketamine at 2 Different Doses in Interventional Sedation and Analgesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sedation Complication
Keywords: Ketamine
Procedural sedation analgesia
Dysphoric reaction
Sedation
Lead sponsor: Aksaray University Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cases with an indication for sedation analgesia, who applied to our emergency department, will be included in our study. Indications for interventional sedation and analgesia: Tube thoracostomy insertion, central venous catheter insertion, fracture/dislocation reduction, skin incision repair, arthrocentesis, lumbar puncture, paracentesis, burn debridement, cardioversion

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: To observe a significant difference between the two doses in terms of producing a dysphoric reaction
timeFrame: January 2023-August 2023
Secondary outcomes:
measure: Efficacy of 0.5 mg/kg and 1 mg/kg IV ketamine
timeFrame: January 2023-August 2023
Other outcomes:
measure: Comparision side effect of iv ketamine between 2 different dose group
timeFrame: January 2023-August 2023
Locations:
city: Aksaray
country: Turkey
facility: Çağrı Türkücü
Study officials:
affiliation: Aksaray UTRH
name: Kamil Kokulu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: