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

NCT ID: NCT05786365

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-31

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.

Conditions

Sedation Complication

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Ketalar 50 MG/ML Injectable Solution

Intervention Type: DRUG

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

The group given 1 mg/kg ketamine

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

Ketalar 50 MG/ML Injectable Solution

Intervention Type: DRUG

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

Interventions

Ketalar 50 MG/ML Injectable Solution

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

Intervention Type: DRUG

Other Intervention Names

ketamine hydrochloride

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aksaray University Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

çağrı türkücü

cagriturkucu

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kamil Kokulu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Aksaray UTRH

Locations

Çağrı Türkücü

Aksaray, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

cagriturkucu

Identifier Type: -

Identifier Source: org_study_id