Sedation ComplicationNCT05786365
Comparison of Emergence/Dysphoric Reaction Frequency of Using 2 Different Doses Ketamine
An observational study of Sedation Complication, run by Aksaray University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effect of using different doses of ketamine on producing dysphoric reaction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sedation Complication
- What is being tested?
- Ketalar 50 MG/ML Injectable Solution
- Type of treatment
- Injection or infusion
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Glaskow coma scale should be 15
- Inability to speak, read or understand English or Turkish
- Patients needing procedural sedation and analgesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Ketalar 50 MG/ML Injectable Solution
- Keywords
- Ketamine, Procedural sedation analgesia, Dysphoric reaction, Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketalar 50 MG/ML Injectable SolutionDrug
Also called ketamine hydrochloride
Ketamine will be administered to two different groups as 0.5 mg/kg and 1 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Ketalar 50 MG/ML Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: January 2023-August 2023
Secondary outcomes (1)
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.
Measured: January 2023-August 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Jan 2023
- Primary completion15 Sep 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, çağrı türkücü, Aksaray University Training and Research Hospital
- Investigators
- Kamil Kokulu, M.D., Principal investigator, Aksaray UTRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786365
- Sponsor's protocol ID
- cagriturkucu
- Status last verified
- Jul 2024
- First submitted
- 22 Feb 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Emergence/Dysphoric Reaction Frequency of Using Ketamine at 2 Different Doses in Interventional Sedation and Analgesia
- ClinicalTrials.gov ID
- NCT05786365
- Acronym / sponsor ID
- cagriturkucu
- Conditions
- Sedation Complication
- Keywords
- Ketamine, Procedural sedation analgesia, Dysphoric reaction, Sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Aksaray University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group given 0.5 mg/kg ketamine | – | Drug: Ketalar 50 MG/ML Injectable SolutionIn this group we will give 0.5 mg/kg ketamine and we observe for disphoric reaction |
| The group given 1 mg/kg ketamine | – | Drug: Ketalar 50 MG/ML Injectable SolutionIn this group we will give 1 mg/kg ketamine and we observe for disphoric reaction |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Glaskow coma scale should be 15
- Inability to speak, read or understand English or Turkish
- Patients needing procedural sedation and analgesia
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketalar 50 MG/ML Injectable SolutionAlso: ketamine hydrochlorideKetamine will be administered to two different groups as 0.5 mg/kg and 1 mg/kg | Drug | The group given 0.5 mg/kg ketamine, The group given 1 mg/kg ketamine |
Primary outcome
To observe a significant difference between the two doses in terms of producing a dysphoric reaction
Time frame: January 2023-August 2023
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.
1 secondary outcome
Efficacy of 0.5 mg/kg and 1 mg/kg IV ketamine
Time frame: January 2023-August 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamil Kokulu, M.D. principal investigator
Aksaray UTRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedation Complication, run by Aksaray University Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To observe a significant difference between the two doses in terms of producing a dysphoric reaction (time frame: January 2023-August 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.