Inguinal HerniaPhase 1NCT05337085
Comparison of Dexmedetomidine and Midazolam for Intra-op Sedation in TIVA in Children Undergoing Inguinal Hernia Repair
A Phase 1 study testing Dexmedetomidine and Midazolam in people with Inguinal Hernia, run by Sheikh Zayed Medical College.
Trial summary
To compare dexmedetomidine and midazolam for intra-op sedation in TIVA in children undergoing inguinal hernia repair. The results of the study if found significant will guide the anesthetist in appropriate choice and dose of sedative drug with highest efficacy and minimum side effects to avoid post operative adverse… Read more about this study
- Who is it for?
- Ages 12 months to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Dexmedetomidine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2022to 20 Mar 2023
- Phase
- 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 12 months to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male and female paediatric patients In age range neonates to 15 years
- Planned for elective inguinal hernia repair
- Patients with uncomplicated hernia With ASA class I or II
Who cannot join
- Patients undergoing emergency inguinal repair
- Patients with ASA class III,IV,V or VI
- Patients present with complicated hernia
- Patients with BMI above 40kg/m2
- Patients with any allergy to anesthesia
- Patients with coagulopathy
- Patients with narcotic/opioid addiction
Trial locations and contacts
No sites are listed yet.
About this study
Official title: To Compare Dexmedetomidine and Midazolam for Intra-op Sedation in TIVA in Children Undergoing Inguinal Hernia Repair
To compare dexmedetomidine and midazolam for intra-op sedation in TIVA in children undergoing inguinal hernia repair. The results of the study if found significant will guide the anesthetist in appropriate choice and dose of sedative drug with highest efficacy and minimum side effects to avoid post operative adverse effects associated with anesthesia
- Conditions
- Inguinal Hernia
- Being tested
- Dexmedetomidine, Midazolam
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Inj dexmedetomidine and inj midazolam given to 2 groups of participants and sedative effects of both drugs will be observed during surgery
MidazolamDrug
Midazolam
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Inj. Dexmedetomidine (precidex) 200/mcg/2ml given to participants in infusion form for 10 mins of surgery and maintenance dose given till the end of surgery Receives: Drug: Dexmedetomidine |
| Midazolam | Active comparator | Inj midazolam 0.5 mg/kg stat dose will be given to participants during surgery Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of sedation assessed through Ramsay Sedation Scale RSS
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start30 Jun 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion20 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies 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
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anab Farooqi, Sheikh Zayed Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337085
- Sponsor's protocol ID
- AFarooqi
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare Dexmedetomidine and Midazolam for Intra-op Sedation in TIVA in Children Undergoing Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT05337085
- Acronym / sponsor ID
- AFarooqi
- Conditions
- Inguinal Hernia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- 30 Jun 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 20 Mar 2023 (estimated)
- First posted
- 20 Apr 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.
To compare dexmedetomidine and midazolam for intra-op sedation in TIVA in children undergoing inguinal hernia repair. The results of the study if found significant will guide the anesthetist in appropriate choice and dose of sedative drug with highest efficacy and minimum side effects to avoid post operative adverse effects associated with anesthesia
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineInj. Dexmedetomidine (precidex) 200/mcg/2ml given to participants in infusion form for 10 mins of surgery and maintenance dose given till the end of surgery |
| Midazolam | Active comparator | Drug: MidazolamInj midazolam 0.5 mg/kg stat dose will be given to participants during surgery |
Who may qualify
- Ages
- 12 months to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male and female paediatric patients In age range neonates to 15 years
- Planned for elective inguinal hernia repair
- Patients with uncomplicated hernia With ASA class I or II
Key exclusion criteria (7 listed)
- Patients undergoing emergency inguinal repair
- Patients with ASA class III,IV,V or VI
- Patients present with complicated hernia
- Patients with BMI above 40kg/m2
- Patients with any allergy to anesthesia
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 |
|---|---|---|
| DexmedetomidineInj dexmedetomidine and inj midazolam given to 2 groups of participants and sedative effects of both drugs will be observed during surgery | Drug | Dexmedetomidine |
| MidazolamMidazolam | Drug | Midazolam |
Primary outcome
Level of sedation assessed through Ramsay Sedation Scale RSS
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- 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 Phase 1 study testing Dexmedetomidine and Midazolam in people with Inguinal Hernia, 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 3 inclusion and 7 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 20 Apr 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Anab Farooqi, MBBS (03337923232, zaibanaab94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of sedation assessed through Ramsay Sedation Scale RSS (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 20 Apr 2022.