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The effect of nebulized dexmedetomidine as sedative premedication in pediatrics undergoing cochlear implantation

Comparison of the effect of two different doses of nebulized dexmedetomidine as sedative premedication in pediatrics undergoing cochlear implantation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202204644214951
Enrollment
50
Registered
2022-04-19
Start date
2021-04-28
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthesia

Interventions

Group A
Group B

Sponsors

Rania Magdi Ali
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age: from 1 to 8 years old sex: male and females American Society of Anesthesiologist physical status (ASA-PS) I-II

Exclusion criteria

Exclusion criteria: Children with suspected difficult airway Children with Body Mass Index (BMI) > 30 Children with mental retardation or neurobehavioral disorders History of allergic reactions to Dexmedetomidine

Design outcomes

Primary

MeasureTime frame
to evaluate and compare parental separation, 30 minutes after premedication with two different doses of nebulized dexmedetomidine using the parental separation anxiety scales PSAS as follow: 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. PSAS scores of 1 and 2 signified calm separation whereas scores of 3 and 4 implied difficult separation.

Secondary

MeasureTime frame
Sedation level was assessed using the Sedation Scale (SS-5). 1= Rarely awake, needs shaking to wake up, 2= Asleep, eyes closed, wake up when lightly touched, 3= Sleepy, but eyes open spontaneously, 4= Awake, and 5= Agitated. The onset of sedation, the minimum time interval necessary to achieve a SS-5 score of 3, and time to Peak sedative effect, the time interval from drug administration to reaching maximum level of sedation, were recorded; Bispectral index (BIS) to measure sedation level. ;Patients Hemodynamics Heart Rate, Mean Arterial Pressure and peripheral O2 saturation SPO2;Ease of venipuncture (EVP) was graded as poor (uncooperative without success), fair (uncooperative with success), good (minor resistance), or excellent (no reaction;Quality of surgical field (QSF) assessed by operating surgeon using QSF score as follow 1 = minimal bleeding: not a surgical annoyance, 2 = mild bleeding: but does not affect dissection, 3 = moderate bleeding: slightly compromises dissection, 4 = severe bleeding: significantly compromises dissection, 5 = massive bleeding: prevent dissection.;Recovery time from discontinuation of anesthesia until child opens his or her eyes and become oriented, was recorded in minutes;Emergence agitation (EA) was assessed in post anesthesia care unit PACU using the Watcha scale as follow 0= Asleep, 1= Calm, 2= Crying, but can be consoled, 3= Crying, but cannot be consoled, 4= Agitated and thrashing around. Score more than 2 indicates the presence of EA;Adverse events such as hypotension (MABP reduction greater than 20% from baseline value) requiring fluid bolus administration, bradycardia (defined as HR< 100 bpm in patients 1-3 years old and <60 beats/min in patients 3-8 years old) requiring atropine administration, hypoxemia (defined as SpO2 <90%), the occurrence of postoperative shivering and postoperative nausea and vomiting were noted.

Countries

Egypt

Contacts

Public ContactRania Magdi Ali

Assistant Professor of Anesthesia intensive care and Pain management faculty of medicine Ain Shams university

rania.magdiali@yahoo.com+201001230545

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026