Procedural SedationEarly Phase 1NCT06368219
Propofol or Benzodiazepine Combined With Ketamine for Procedural Sedation in Emergency Setting
A Early Phase 1 study testing ketamine- midazolam versus ketamine- propofol in people with Procedural Sedation, run by Alexandria University.
Trial summary
This single blinded parallel randomized clinical trial will be conducted on 50 patients presented to Emergency Department of Alexandria Main University Hospital who are indicated for procedural sedation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Procedural Sedation
- What is being tested?
- ketamine- midazolam versus ketamine- propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Oct 2024
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years) requiring procedural sedation and analgesia for painful procedures in ED . The following procedures are indications for PSA:
- Cardioversion
- Reduction of fracture or joint dislocation
- Procedures as central venous catheter (CVC) and chest tube insertion or wound management
Who cannot join
- Patients with anticipated difficult airway.
- Post cardiac arrest patients.
- Contraindication to study drugs.
- Pregnant women.
- Patients > 65 years.
Trial locations and contacts
No sites are listed yet.
About this study
This single blinded parallel randomized clinical trial will be conducted on 50 patients presented to Emergency Department of Alexandria Main University Hospital who are indicated for procedural sedation. All patients included in the study will be allocated randomly using computer software with concealment of randomization in to two groups:
- Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg)
- Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg) Additional ketamine (0.25 mg/kg) will be administered in case of inadequate sedation in both groups. the two groups will be compared as regard incidence of complications World Society of Intravenous Anesthesia (SIVA) international sedation task force to standardize reporting adverse events
- Conditions
- Procedural Sedation
- Being tested
- ketamine- midazolam versus ketamine- propofol
- Keywords
- midazolam, propofol, ketamine, procedural sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamine- midazolam versus ketamine- propofolDrug
- Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg)
- Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| midazolam- ketamine combination | Active comparator | - Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg Receives: Drug: ketamine- midazolam versus ketamine- propofol |
| propofol- ketamine combination | Active comparator | - Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg)( Receives: Drug: ketamine- midazolam versus ketamine- propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction and recovery time for both combinations
the induction and recovery time of ketamine/midazolam versus ketamine/propofol combinations used for procedural sedation in an Emergency setting.
Measured: 2 hours
Secondary outcomes (1)
incidence and severity of adverse events
- Incidence of complications between the two groups using World Society of Intravenous Anesthesia (SIVA) international sedation task force to standardize reporting adverse events
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368219
- Sponsor's protocol ID
- 0108161
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 16 Apr 2024
- Results posted
- 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 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol or Benzodiazepine Combined With Ketamine for Procedural Sedation in Emergency Setting
- ClinicalTrials.gov ID
- NCT06368219
- Acronym / sponsor ID
- 0108161
- Conditions
- Procedural Sedation
- Keywords
- midazolam, propofol, ketamine, procedural sedation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 16 Apr 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.
This single blinded parallel randomized clinical trial will be conducted on 50 patients presented to Emergency Department of Alexandria Main University Hospital who are indicated for procedural sedation. All patients included in the study will be allocated randomly using computer software with concealment of randomization in to two groups:
- Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg)
- Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg) Additional ketamine (0.25 mg/kg) will be administered in case of inadequate sedation in both groups. the two groups will be compared as regard incidence of complications World Society of Intravenous Anesthesia (SIVA) international sedation task force to standardize reporting adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| midazolam- ketamine combination | Active comparator | Drug: ketamine- midazolam versus ketamine- propofol- Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg |
| propofol- ketamine combination | Active comparator | Drug: ketamine- midazolam versus ketamine- propofol- Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg)( |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (≥18 years) requiring procedural sedation and analgesia for painful procedures in ED . The following procedures are indications for PSA:
- Cardioversion
- Reduction of fracture or joint dislocation
- Procedures as central venous catheter (CVC) and chest tube insertion or wound management
Key exclusion criteria (5 listed)
- Patients with anticipated difficult airway.
- Post cardiac arrest patients.
- Contraindication to study drugs.
- Pregnant women.
- Patients > 65 years.
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 |
|---|---|---|
| ketamine- midazolam versus ketamine- propofol* Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg) * Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg) | Drug | midazolam- ketamine combination, propofol- ketamine combination |
Primary outcome
Induction and recovery time for both combinations
Time frame: 2 hours
the induction and recovery time of ketamine/midazolam versus ketamine/propofol combinations used for procedural sedation in an Emergency setting.
1 secondary outcome
incidence and severity of adverse events
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ketamine- midazolam versus ketamine- propofol in people with Procedural Sedation, run by Alexandria University.
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 4 inclusion and 5 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 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Asmaa Ramadan (01274627276, a_ramadan15@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction and recovery time for both combinations (time frame: 2 hours). 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 16 Apr 2024.