Subanesthetic Ketamine DexmedetomidinNCT06498700
Intraoperative Subanesthetic Ketamine Versus Dexmedetomidine Infusion for Prevention of Post-traumatic Stress Disorder After Traumatic Brain Surgeries
A study testing ketamine and dexmedetomidine in people with Subanesthetic Ketamine Dexmedetomidin, run by Zagazig University at 1 site in Egypt.
Trial summary
Prevention of Post-traumatic Stress Disorder after traumatic Brain surgeries by using either subanesthetic ketamine or dexmedetomidine infusion. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Subanesthetic Ketamine Dexmedetomidin
- What is being tested?
- ketamine and dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2024to 15 Mar 2025
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-60 years old.Body mass index of less than or equal 35.American Society of I and II.Duration of surgery not more than 3 hours.
Who cannot join
- Known hypersensitivity to dexmedetomidine or ketamine. Hemorrhagic shock decompensation.History of alcohol or drug abuse.History of neurologic or psychiatric diseases Advanced renal ,liver or cardiovascular disorders.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine,Zagazig University
Zagazig, Sharqia Province, 44519
About this study
Official title: Intraoperative Subanesthetic Ketamine Versus Dexmedetomidine Infusion for Prevention of Post-traumatic Stress Disorder After Traumatic Brain Surgeries: A Randomized Trial
Prevention of Post-traumatic Stress Disorder after traumatic Brain surgeries by using either subanesthetic ketamine or dexmedetomidine infusion.
Read the detailed description
after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into two equal groups (K group and D group). Using computer generated randomization table; each group consists of 26 patients: K group (n=26): Patient will receive with 0.5 mg/kg/h ketamine infusion. D group (n=26): Patient will receive 0.1 ug/kg/h dexmedetomidine infusion.
- Conditions
- Subanesthetic Ketamine Dexmedetomidin
- Being tested
- ketamine, dexmedetomidine
- Keywords
- Ketamine, Dexmedetomidine ,Post-traumatic Stress Disorder , traumatic Brain surgeries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
0.5 mg/kg/h ketamine infusion
dexmedetomidineDrug
0.1 ug/kg/h dexmedetomidine infusion
| Study group | Role | What they receive |
|---|---|---|
| Ketamine(K) | Experimental | 0.5 mg/kg/h ketamine infusion Receives: Drug: ketamine |
| dexmedetomidine(D) | Experimental | 0.1 ug/kg/h dexmedetomidine infusion Receives: Drug: dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
(PTSD)
To measure the change in PTSD symptom severity using the PTSD Checklist
Measured: 6 months
Secondary outcomes (2)
VAS
postoperative pain
Measured: (24 hours, 48 hours, and 1 month)
postoperative delirium
using the confusion assessment method criteria
Measured: twice daily for 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start15 Jul 2024
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subanesthetic Ketamine DexmedetomidinStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marwa Mohamed Medhat, Zagazig University
- Investigators
- marwa M Medhat, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498700
- Sponsor's protocol ID
- 440
- Status last verified
- Aug 2024
- First submitted
- 7 Jul 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Subanesthetic Ketamine Versus Dexmedetomidine Infusion for Prevention of Post-traumatic Stress Disorder After Traumatic Brain Surgeries: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06498700
- Acronym / sponsor ID
- 440
- Conditions
- Subanesthetic Ketamine Dexmedetomidin
- Keywords
- Ketamine, Dexmedetomidine ,Post-traumatic Stress Disorder , traumatic Brain surgeries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 12 Jul 2024 (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.
Prevention of Post-traumatic Stress Disorder after traumatic Brain surgeries by using either subanesthetic ketamine or dexmedetomidine infusion.
Detailed description
after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into two equal groups (K group and D group). Using computer generated randomization table; each group consists of 26 patients: K group (n=26): Patient will receive with 0.5 mg/kg/h ketamine infusion. D group (n=26): Patient will receive 0.1 ug/kg/h dexmedetomidine infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine(K) | Experimental | Drug: ketamine0.5 mg/kg/h ketamine infusion |
| dexmedetomidine(D) | Experimental | Drug: dexmedetomidine0.1 ug/kg/h dexmedetomidine infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Aged 18-60 years old.Body mass index of less than or equal 35.American Society of I and II.Duration of surgery not more than 3 hours.
Key exclusion criteria (1 listed)
- Known hypersensitivity to dexmedetomidine or ketamine. Hemorrhagic shock decompensation.History of alcohol or drug abuse.History of neurologic or psychiatric diseases Advanced renal ,liver or cardiovascular disorders.
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 |
|---|---|---|
| ketamine0.5 mg/kg/h ketamine infusion | Drug | Ketamine(K) |
| dexmedetomidine0.1 ug/kg/h dexmedetomidine infusion | Drug | dexmedetomidine(D) |
Primary outcome
(PTSD)
Time frame: 6 months
To measure the change in PTSD symptom severity using the PTSD Checklist
2 secondary outcomes
VAS
Time frame: (24 hours, 48 hours, and 1 month)
postoperative delirium
Time frame: twice daily for 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: No
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.
marwa M Medhat principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketamine and dexmedetomidine in people with Subanesthetic Ketamine Dexmedetomidin, run by Zagazig University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Aug 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 Egypt. 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?
Results are not available in the source record.
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?
(PTSD) (time frame: 6 months). 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 19 Aug 2024.