Emergence DeliriumPhase 1NCT05872087
Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Children Undergoing Lower Abdominal Surgeries
A Phase 1 study testing Nebulised Dexmeditomidine and Nebulised Midazolam in people with Emergence Delirium and Anxiety Preoperative, run by Ain Shams University at 1 site in Egypt.
Trial summary
Comparative study between nebulised dexmedetomidine and nebulized midazolam in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Delirium, Anxiety Preoperative
- What is being tested?
- Nebulised Dexmeditomidine and Nebulised Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Feb 2024
- 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 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 3-8 years
- ASA I\&II
- Undergoing lower abdominal surgeries for example hernia repair and circumcision
Who cannot join
- Children with chest infection, respiratory disease, cardiac disease
- Children with mental or physical disabilities, treatment with sedatives and anticonvulsants
- Parental refusal
- Allergy to study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Reducing Preoperative Anxiety and Emergence Delirium in Children Undergoing Lower Abdominal Surgeries
Comparative study between nebulised dexmedetomidine and nebulized midazolam in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries
Read the detailed description
Dexmedetomidine is widely used in children and is replacing midazolam as the drug of choice for preoperative anxiolysis and sedation. However, there are limited studies comparing nebulized route in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries
- Conditions
- Emergence Delirium, Anxiety Preoperative
- Being tested
- Nebulised Dexmeditomidine, Nebulised Midazolam
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulised DexmeditomidineDrug
Also called premedication by nebulised dexmeditomidine
premedication by dexmeditomidine 3mcg/kg in children undergoing lower abdominal surgeries
Nebulised MidazolamDrug
Also called Premedication by nebulised midazolam
premedication by nebulised midazolam 0.3mg/kg in children undergoing lower abdominal surgeries
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | will receive nebulized Dexmedetomidine 3 µg/kg Receives: Drug: Nebulised Dexmeditomidine |
| Midazolam | Active comparator | will receive nebulized Midazolam 0.3 mg/kg Receives: Drug: Nebulised Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of preoperative anxiety
The level of anxiety of the child during separation from parents according to Parental separation anxiety scale (PSAS), with a 4-point scale as: 1=easy separation; 2=whimpers, but is easily reassured, not clinging; 3=cries and cannot be easily reassured, but not clinging to parents and 4=crying and clinging to parents
Measured: 30 minutes after drug administration
Incidence of emergence delirium
Incidence of emergence delirium, wake up behaviour will be assessed according to Watcha scale where Score is observed values as follows: 0= asleep, 1=calm, 2=crying but can be consoled, 3=crying but cannot be consoled, 4=agitating and thrashing around
Measured: immediate postoperative
Secondary outcomes (5)
the level of sedation
The level of sedation when the child first seen in the operating room 30 minutes after sedation using Ramsey sedation scale
Measured: 30 minutes after drug administration
hemodynamic changes
number of participants experienced any hemodynamic changes if more than 20% change in mean arterial pressure (MAP) and Heart Rate (HR).
Measured: perioperative
PONV
Incidence of post-operative nausea and vomiting.
Measured: perioperative
recovery time
Recovery time, time between laryngeal mask removal and discharge from recovery room.
Measured: up to 2 hours postoperative
total fentanyl use
Total fentanyl use during operation
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Nov 2022
- Primary completion1 Sep 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872087
- Sponsor's protocol ID
- midazolam vs dexmedetomidine
- Status last verified
- May 2023
- First submitted
- 22 Mar 2023
- Last updated
- 24 May 2024
- 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 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Reducing Preoperative Anxiety and Emergence Delirium in Children Undergoing Lower Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT05872087
- Acronym / sponsor ID
- midazolam vs dexmedetomidine
- Conditions
- Emergence Delirium, Anxiety Preoperative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 24 May 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.
Comparative study between nebulised dexmedetomidine and nebulized midazolam in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries
Detailed description
Dexmedetomidine is widely used in children and is replacing midazolam as the drug of choice for preoperative anxiolysis and sedation. However, there are limited studies comparing nebulized route in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Nebulised Dexmeditomidinewill receive nebulized Dexmedetomidine 3 µg/kg |
| Midazolam | Active comparator | Drug: Nebulised Midazolamwill receive nebulized Midazolam 0.3 mg/kg |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 3-8 years
- ASA I\&II
- Undergoing lower abdominal surgeries for example hernia repair and circumcision
Key exclusion criteria (4 listed)
- Children with chest infection, respiratory disease, cardiac disease
- Children with mental or physical disabilities, treatment with sedatives and anticonvulsants
- Parental refusal
- Allergy to study drugs
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 |
|---|---|---|
| Nebulised DexmeditomidineAlso: premedication by nebulised dexmeditomidinepremedication by dexmeditomidine 3mcg/kg in children undergoing lower abdominal surgeries | Drug | Dexmedetomidine |
| Nebulised MidazolamAlso: Premedication by nebulised midazolampremedication by nebulised midazolam 0.3mg/kg in children undergoing lower abdominal surgeries | Drug | Midazolam |
Primary outcome
level of preoperative anxiety
Time frame: 30 minutes after drug administration
The level of anxiety of the child during separation from parents according to Parental separation anxiety scale (PSAS), with a 4-point scale as: 1=easy separation; 2=whimpers, but is easily reassured, not clinging; 3=cries and cannot be easily reassured, but not clinging to parents and 4=crying and clinging to parents
Incidence of emergence delirium
Time frame: immediate postoperative
Incidence of emergence delirium, wake up behaviour will be assessed according to Watcha scale where Score is observed values as follows: 0= asleep, 1=calm, 2=crying but can be consoled, 3=crying but cannot be consoled, 4=agitating and thrashing around
5 secondary outcomes
the level of sedation
Time frame: 30 minutes after drug administration
hemodynamic changes
Time frame: perioperative
PONV
Time frame: perioperative
recovery time
Time frame: up to 2 hours postoperative
total fentanyl use
Time frame: intraoperative
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 24 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nebulised Dexmeditomidine and Nebulised Midazolam in people with Emergence Delirium and Anxiety Preoperative, run by Ain Shams 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 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 24 May 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.
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?
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?
level of preoperative anxiety (time frame: 30 minutes after drug administration). The study lists 2 primary outcomes in all. 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 24 May 2024.