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

NCT05786365 | Completed FDA Drug

• 1 other identifier: cagriturkucu
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sedation Complication

Keywords

Ketamine; Procedural sedation analgesia; Dysphoric reaction; Sedation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficacy of 0.5 mg/kg and 1 mg/kg IV ketamine

  January 2023-August 2023

Other Outcomes (1)

• Comparision side effect of iv ketamine between 2 different dose group

  January 2023-August 2023

Study Arms (2)

The group given 0.5 mg/kg ketamine

In this group we will give 0.5 mg/kg ketamine and we observe for disphoric reaction

Drug: Ketalar 50 MG/ML Injectable Solution

The group given 1 mg/kg ketamine

In this group we will give 1 mg/kg ketamine and we observe for disphoric reaction

Drug: Ketalar 50 MG/ML Injectable Solution

Interventions

Ketalar 50 MG/ML Injectable Solution DRUG

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

Also known as: ketamine hydrochloride

The group given 0.5 mg/kg ketamine; The group given 1 mg/kg ketamine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Glaskow coma scale should be 15
• Inability to speak, read or understand English or Turkish
• Patients needing procedural sedation and analgesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Aksaray University Training and Research Hospital: lead

Study Sites (1)

Çağrı Türkücü

Aksaray, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Kamil Kokulu, M.D.

  Aksaray UTRH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: cagriturkucu

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 27, 2023
• Study Start: January 1, 2023
• Primary Completion: September 15, 2023
• Study Completion: December 31, 2023
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)