Mother's Recorded Voice Versus Dexmedetomidine on Postoperative Agitation

NCT04941508 | Completed Phase 3 DMC

• 1 other identifier: 17300621
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Agitation, Emergence

Outcome Measures

Primary Outcomes (1)

• 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

  2 hours Postoperative

Secondary Outcomes (1)

• Face, Legs, Activity, Cry, and Consolability (FLACC) score

  24 hours Postoperative

Study Arms (3)

Mother's recorded voice

EXPERIMENTAL

Children will be exposed to the mother's voice.

Behavioral: the mother's recorded voice

Dexmedetomidine IV

EXPERIMENTAL

Children will be given dexmedetomidine injection.

Drug: Dexmedetomidine

Saline placebo IV

PLACEBO COMPARATOR

Children will be given normal saline.

Other: saline 0.9% placebo

Interventions

the mother's recorded voice BEHAVIORAL

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).

Mother's recorded voice

Dexmedetomidine DRUG

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).

Also known as: Precedex

Dexmedetomidine IV

saline 0.9% placebo OTHER

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).

Also known as: Normal saline

Saline placebo IV

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Assiut university hospital

Asyut, Assuit university, Egypt

Location

Omar Soliman

Asyut, Assuit universi, Egypt

Location

Related Publications (1)

• 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.

  PMID: 26171895 RESULT

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Omar Soliman, MD

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and ICU

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 28, 2021
• Study Start: June 25, 2021
• Primary Completion: November 3, 2021
• Study Completion: November 5, 2021
• Last Updated: November 18, 2021

Record last verified: 2021-11

Locations

EG (2)