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

Sedation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05786365
• Other study ID #: cagriturkucu
• Status: Active, not recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2023
• Source: Aksaray University Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: December 31, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedation Complication

Intervention

Drug:
• Ketalar 50 MG/ML Injectable Solution
Ketamine will be administered to two different groups as 0.5 mg/kg and 1 mg/kg

Locations

Country	Name	City	State
Turkey	Çagri Türkücü	Aksaray

Sponsors (1)

Lead Sponsor	Collaborator
Aksaray University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparision side effect of iv ketamine between 2 different dose group	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 in terms of the incidence of side effects.We monitored patients for the following side effects:Hypertension(Defined as a systolic blood pressure (SBP) of 140 mm Hg or more),tachycardia (Heart rate of more than 100 beats per minute),diplopia or nystagmus, nausea and vomiting, respiratory depression (apnea occurring over 10 seconds or oxygen saturation falling below 90%)	January 2023-August 2023
Primary	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	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.	January 2023-August 2023