Agitation, EmergencePhase 3NCT04941508
Mother's Recorded Voice Versus Dexmedetomidine on Postoperative Agitation
A Phase 3 study testing the mother's recorded voice and Dexmedetomidine in people with Agitation, Emergence, run by Assiut University at 2 sites in Egypt.
Trial summary
The aim of this study is to compare the efficacy of mother's recorded voice versus dexmedetomidine injection on postoperative agitation in children undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Agitation, Emergence
- What is being tested?
- the mother's recorded voice and Dexmedetomidine
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesEgypt
- Study dates
- 25 Jun 2021to 5 Nov 2021
- Phase
- Phase 3
- 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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (age 4-9 years)
- American Society of Anesthesiologists physical status (ASA) I-II who will be listed for outpatient elective surgery under general anesthesia.
Who cannot join
- Developmental delays
- Neurological diseases
- Deafness
- Hearing impairment
- Maternal mutism
- Absence of the mother
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Assiut university hospital
Asyut, Assuit university
Omar Soliman
Asyut, Assuit universi
About this study
Official title: Mother's Recorded Voice: a Neglected Therapeutic Stance for Pediatric Postoperative Agitation
The aim of this study is to compare the efficacy of mother's recorded voice versus dexmedetomidine injection on postoperative agitation in children undergoing elective surgery.
Read the detailed description
A written informed consent will be taken from the patients' legal guardians.Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized and either randomly assigned to listen to the mother's recorded voice at 2 times (in the holding area 3 minutes before induction of anesthesia till induction of anesthesia is ended) and (during emergence from anesthesia till complete recovery) (Group M) or will be given a single bolus of dexmedetomidine 0.2 µ/kg IV at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery) (Group D) or given the same volume of saline IV at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery) (Group C).To keep blinding, group M will be injected IV with the same volume of saline at the same 2 times as in groups D \& C while in groups D \& C, headphones will be putted as in group M at the same 2 times with no recorded voice.
- Conditions
- Agitation, Emergence
- Being tested
- the mother's recorded voice, Dexmedetomidine, saline 0.9% placebo
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the mother's recorded voiceBehavioural
Children will be assigned to listen to the mother's recorded voice at 2 times (in the holding area 3 minutes before induction of anesthesia till induction of anesthesia is ended) and (during emergence from anesthesia till complete recovery).
DexmedetomidineDrug
Also called Precedex
Children will be given a single bolus of dexmedetomidine 0.2 µ/kg IV at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery).
saline 0.9% placeboOther
Also called Normal saline
Children will be given the same volume of saline at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery).
| Study group | Role | What they receive |
|---|---|---|
| Mother's recorded voice | Experimental | Children will be exposed to the mother's voice. Receives: Behavioral: the mother's recorded voice |
| Dexmedetomidine IV | Experimental | Children will be given dexmedetomidine injection. Receives: Drug: Dexmedetomidine |
| Saline placebo IV | Placebo comparator | Children will be given normal saline. Receives: Other: saline 0.9% placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric anesthesia of emergence delirium (PAED) score
Emergence delirium (ED) will be measured by the pediatric anesthesia of emergence delirium (PAED).The scores for each of the five listed behaviours(makes eye contact with caregiver, actions are purposeful,aware of surroundings, restless and inconsolable) are added to achieve a total score (maximum score of 20). A score of >12 yields 100% sensitivity and 94.5% specificity for the diagnosis of ED
Measured: 2 hours Postoperative
Secondary outcomes (1)
Face, Legs, Activity, Cry, and Consolability (FLACC) score
Pain will be measured by Face, Legs, Activity, Cry, and Consolability (FLACC) score ranging from 0 to 10 where 0= relaxed and no pain, 1-3= mild pain/discomfort, 4-6= moderate pain, 7-10= severe discomfort/pain.
Measured: 24 hours Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start25 Jun 2021
- Primary completion3 Nov 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Agitation, EmergenceStudies of the same condition, open and under way.
- More trials run by Assiut 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Makram Soliman, Assiut University
- Investigators
- Omar Soliman, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941508
- Sponsor's protocol ID
- 17300621
- Status last verified
- Nov 2021
- First submitted
- 15 Jun 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Manyande A, Cyna AM, Yip P, Chooi C, Middleton P. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD006447. doi: 10.1002/14651858.CD006447.pub3.
PubMed 26171895
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mother's Recorded Voice: a Neglected Therapeutic Stance for Pediatric Postoperative Agitation
- ClinicalTrials.gov ID
- NCT04941508
- Acronym / sponsor ID
- 17300621
- Conditions
- Agitation, Emergence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 28 Jun 2021 (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.
The aim of this study is to compare the efficacy of mother's recorded voice versus dexmedetomidine injection on postoperative agitation in children undergoing elective surgery.
Detailed description
A written informed consent will be taken from the patients' legal guardians.Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized and either randomly assigned to listen to the mother's recorded voice at 2 times (in the holding area 3 minutes before induction of anesthesia till induction of anesthesia is ended) and (during emergence from anesthesia till complete recovery) (Group M) or will be given a single bolus of dexmedetomidine 0.2 µ/kg IV at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery) (Group D) or given the same volume of saline IV at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery) (Group C).To keep blinding, group M will be injected IV with the same volume of saline at the same 2 times as in groups D \& C while in groups D \& C, headphones will be putted as in group M at the same 2 times with no recorded voice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mother's recorded voice | Experimental | Behavioral: the mother's recorded voiceChildren will be exposed to the mother's voice. |
| Dexmedetomidine IV | Experimental | Drug: DexmedetomidineChildren will be given dexmedetomidine injection. |
| Saline placebo IV | Placebo comparator | Other: saline 0.9% placeboChildren will be given normal saline. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children (age 4-9 years)
- American Society of Anesthesiologists physical status (ASA) I-II who will be listed for outpatient elective surgery under general anesthesia.
Key exclusion criteria (6 listed)
- Developmental delays
- Neurological diseases
- Deafness
- Hearing impairment
- Maternal mutism
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 |
|---|---|---|
| the mother's recorded voiceChildren will be assigned to listen to the mother's recorded voice at 2 times (in the holding area 3 minutes before induction of anesthesia till induction of anesthesia is ended) and (during emergence from anesthesia till complete recovery). | Behavioural | Mother's recorded voice |
| DexmedetomidineAlso: PrecedexChildren will be given a single bolus of dexmedetomidine 0.2 µ/kg IV at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery). | Drug | Dexmedetomidine IV |
| saline 0.9% placeboAlso: Normal salineChildren will be given the same volume of saline at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery). | Other | Saline placebo IV |
Primary outcome
Pediatric anesthesia of emergence delirium (PAED) score
Time frame: 2 hours Postoperative
Emergence delirium (ED) will be measured by the pediatric anesthesia of emergence delirium (PAED).The scores for each of the five listed behaviours(makes eye contact with caregiver, actions are purposeful,aware of surroundings, restless and inconsolable) are added to achieve a total score (maximum score of 20). A score of >12 yields 100% sensitivity and 94.5% specificity for the diagnosis of ED
1 secondary outcome
Face, Legs, Activity, Cry, and Consolability (FLACC) score
Time frame: 24 hours Postoperative
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 18 Nov 2021.
- Results publication: PubMed 26171895Manyande A, Cyna AM, Yip P, Chooi C, Middleton P. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD006447. doi: 10.1002/14651858.CD006447.pub3.
- Individual participant dataSharing planned: Undecided
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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.
Omar Soliman, MD study director
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing the mother's recorded voice and Dexmedetomidine in people with Agitation, Emergence, run by Assiut University at 2 sites 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 2 inclusion and 6 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 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pediatric anesthesia of emergence delirium (PAED) score (time frame: 2 hours Postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04941508, which also lists 1 linked publication.
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 18 Nov 2021.