Mother's Recorded Voice Versus Dexmedetomidine on Postoperative Agitation
NCT ID: NCT04941508
Last Updated: 2021-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
90 participants
INTERVENTIONAL
2021-06-25
2021-11-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mother's recorded voice
Children will be exposed to the mother's voice.
the mother's recorded voice
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).
Dexmedetomidine IV
Children will be given dexmedetomidine injection.
Dexmedetomidine
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 placebo IV
Children will be given normal saline.
saline 0.9% placebo
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).
Interventions
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the mother's recorded voice
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).
Dexmedetomidine
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% placebo
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists physical status (ASA) I-II who will be listed for outpatient elective surgery under general anesthesia.
Exclusion Criteria
* Neurological diseases
* Deafness
* Hearing impairment
* Maternal mutism
* Absence of the mother
4 Years
9 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Omar Makram Soliman
Lecturer of anesthesia and ICU
Principal Investigators
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Omar Soliman, MD
Role: STUDY_DIRECTOR
Assiut University
Locations
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Assiut university hospital
Asyut, , Egypt
Omar Soliman
Asyut, , Egypt
Countries
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References
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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.
Other Identifiers
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17300621
Identifier Type: -
Identifier Source: org_study_id