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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Sedation Complication
• Intervention / Treatment: Drug: Ketalar 50 MG/ML Injectable Solution

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.

• Study Type: Observational
• Enrollment (Estimated): 108

Contacts and Locations

Study Locations

• Turkey
  • Aksaray, Turkey
    • Çağrı Türkücü

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Ketamine will be administered to two different groups as 0.5 mg/kg and 1 mg/kg; Other Names: ketamine hydrochloride
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; Ketamine will be administered to two different groups as 0.5 mg/kg and 1 mg/kg; Other Names: ketamine hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aksaray University Training and Research Hospital
• Investigators: Principal Investigator: Kamil Kokulu, M.D., Aksaray UTRH

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): September 15, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 10, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Ketamine; Sedation; Procedural sedation analgesia; Dysphoric reaction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: cagriturkucu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No