Mother's Recorded Voice Versus Dexmedetomidine on Postoperative Agitation

Assiut University

Status and phase: Completed; Phase 3

Conditions: Agitation, Emergence

Treatments: Other: saline 0.9% placebo; Drug: Dexmedetomidine; Behavioral: the mother's recorded voice

Study type: Interventional

Funder types: Other

Identifiers

NCT04941508

17300621

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 4 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Developmental delays
• Neurological diseases
• Deafness
• Hearing impairment
• Maternal mutism
• Absence of the mother

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Mother's recorded voice

Experimental group

Description:

Children will be exposed to the mother's voice.

Treatment:

Behavioral: the mother's recorded voice

Dexmedetomidine IV

Experimental group

Description:

Children will be given dexmedetomidine injection.

Treatment:

Drug: Dexmedetomidine

Saline placebo IV

Placebo Comparator group

Description:

Children will be given normal saline.

Treatment:

Other: saline 0.9% placebo