Choosing Better Drug Option for Sedation in Pediatric Population IntraoperativelyEarly Phase 1NCT05574179
Comparison of Sedative Effect of Dexmedetomidine and Midazolam for TIVA
A Early Phase 1 study testing Dexmedetomidine injection and Midazolam in people with Choosing Better Drug Option for Sedation in Pediatric Population Intraoperatively, run by Sheikh Zayed Medical College.
Trial summary
Comparison of sedative effects of dexmedetomidine and midazolam using ramsay sedation scores intraoperatively in children undergoing inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Choosing Better Drug Option for Sedation in Pediatric Population Intraoperatively
- What is being tested?
- Dexmedetomidine injection and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Oct 2023
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA I and II Age 6 to 12 years Any gender
Who cannot join
- ASA III and above Age less than 2 years and above 12 years Congenital heart disease Cardiac arrythmias Congenital abnormalities Respiratory disease Endocrine disorders Mental retardation Organ dysfunction Bleeding disorders Physician or family refusal Previous surgeries Allergy to any drug
About this study
Official title: Comparison of Sedative Effect of Dexmedetomidine and Midazolam for TIVA in Pediatric Population Undergoing Inguinal Hernia Repair, Randomized Controlled Trial
Comparison of sedative effects of dexmedetomidine and midazolam using ramsay sedation scores intraoperatively in children undergoing inguinal hernia repair.
Read the detailed description
a randomized controlled trial to compare the sesative effects of dexmedetomidine and midazolam in pediatric population planned for inguinal herna repair under TIVA in sheikh zayed hospital rahim yar khan.
- Being tested
- Dexmedetomidine injection, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine injectionDrug
Also called Precidex
Inj precedex 200mcg in 1ml given in stat doses
MidazolamDrug
Inj.midazolam 5mg/5ml given in stat doses
| Study group | Role | What they receive |
|---|---|---|
| midazola. | Experimental | Inj.midazolam Receives: Drug: Midazolam |
| Dexnedetomidine | Experimental | inj.dexmedetomidine Receives: Drug: Dexmedetomidine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dexmedetomidine is better sedative agent than midazolam in pediatric population
Measured: 25 minutes
Secondary outcomes (2)
Midazolam is better sedating agent than dexmedetomidine in pediatric population
Measured: 25 minutes
Midazolam and dexmedetomidine are equally good sedating agents in pediatric population
Measured: 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choosing Better Drug Option for Sedation in Pediatric Population IntraoperativelyStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Barzah Durrani, Sheikh Zayed Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574179
- Sponsor's protocol ID
- Sheikh Zayed Medical College
- Status last verified
- Oct 2022
- First submitted
- 6 Oct 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sedative Effect of Dexmedetomidine and Midazolam for TIVA in Pediatric Population Undergoing Inguinal Hernia Repair, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05574179
- Acronym / sponsor ID
- Sheikh Zayed Medical College
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 10 Oct 2022 (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.
Comparison of sedative effects of dexmedetomidine and midazolam using ramsay sedation scores intraoperatively in children undergoing inguinal hernia repair.
Detailed description
a randomized controlled trial to compare the sesative effects of dexmedetomidine and midazolam in pediatric population planned for inguinal herna repair under TIVA in sheikh zayed hospital rahim yar khan.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| midazola. | Experimental | Drug: MidazolamInj.midazolam |
| Dexnedetomidine | Experimental | Drug: Dexmedetomidine injectioninj.dexmedetomidine |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA I and II Age 6 to 12 years Any gender
Key exclusion criteria (1 listed)
- ASA III and above Age less than 2 years and above 12 years Congenital heart disease Cardiac arrythmias Congenital abnormalities Respiratory disease Endocrine disorders Mental retardation Organ dysfunction Bleeding disorders Physician or family refusal Previous surgeries Allergy to any drug
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 |
|---|---|---|
| Dexmedetomidine injectionAlso: PrecidexInj precedex 200mcg in 1ml given in stat doses | Drug | Dexnedetomidine |
| MidazolamInj.midazolam 5mg/5ml given in stat doses | Drug | midazola. |
Primary outcome
Dexmedetomidine is better sedative agent than midazolam in pediatric population
Time frame: 25 minutes
2 secondary outcomes
Midazolam is better sedating agent than dexmedetomidine in pediatric population
Time frame: 25 minutes
Midazolam and dexmedetomidine are equally good sedating agents in pediatric population
Time frame: 25 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexmedetomidine injection and Midazolam in people with Choosing Better Drug Option for Sedation in Pediatric Population Intraoperatively, run by Sheikh Zayed Medical College.
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 10 Oct 2022. 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?
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?
Dexmedetomidine is better sedative agent than midazolam in pediatric population (time frame: 25 minutes). 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 10 Oct 2022.