Back to resultsComparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Children Undergoing Lower Abdominal Surgeries
Primary Purpose
Emergence Delirium, Anxiety Preoperative
Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Nebulised Dexmeditomidine
Nebulised Midazolam
Sponsored by
About this trial
This is an interventional prevention trial for Emergence Delirium
Eligibility Criteria
Inclusion Criteria: Children aged 3-8 years ASA I&II Undergoing lower abdominal surgeries for example hernia repair and circumcision Exclusion Criteria: Children with chest infection, respiratory disease, cardiac disease Children with mental or physical disabilities, treatment with sedatives and anticonvulsants Parental refusal Allergy to study drugs
Sites / Locations
- Ainshams UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dexmedetomidine
Midazolam
Arm Description
will receive nebulized Dexmedetomidine 3 µg/kg
will receive nebulized Midazolam 0.3 mg/kg
Outcomes
Primary Outcome Measures
level of preoperative anxiety
The level of anxiety of the child during separation from parents according to Parental separation anxiety scale (PSAS), with a 4-point scale as: 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
Incidence of emergence delirium
Incidence of emergence delirium, wake up behaviour will be assessed according to Watcha scale where Score is observed values as follows: 0= asleep, 1=calm, 2=crying but can be consoled, 3=crying but cannot be consoled, 4=agitating and thrashing around
Secondary Outcome Measures
the level of sedation
The level of sedation when the child first seen in the operating room 30 minutes after sedation using Ramsey sedation scale
hemodynamic changes
number of participants experienced any hemodynamic changes if more than 20% change in mean arterial pressure (MAP) and Heart Rate (HR).
PONV
Incidence of post-operative nausea and vomiting.
recovery time
Recovery time, time between laryngeal mask removal and discharge from recovery room.
total fentanyl use
Total fentanyl use during operation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05872087
Brief Title
Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Children Undergoing Lower Abdominal Surgeries
Official Title
Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Reducing Preoperative Anxiety and Emergence Delirium in Children Undergoing Lower Abdominal Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparative study between nebulised dexmedetomidine and nebulized midazolam in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries
Detailed Description
Dexmedetomidine is widely used in children and is replacing midazolam as the drug of choice for preoperative anxiolysis and sedation. However, there are limited studies comparing nebulized route in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Delirium, Anxiety Preoperative
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
will receive nebulized Dexmedetomidine 3 µg/kg
Arm Title
Midazolam
Arm Type
Active Comparator
Arm Description
will receive nebulized Midazolam 0.3 mg/kg
Intervention Type
Drug
Intervention Name(s)
Nebulised Dexmeditomidine
Other Intervention Name(s)
premedication by nebulised dexmeditomidine
Intervention Description
premedication by dexmeditomidine 3mcg/kg in children undergoing lower abdominal surgeries
Intervention Type
Drug
Intervention Name(s)
Nebulised Midazolam
Other Intervention Name(s)
Premedication by nebulised midazolam
Intervention Description
premedication by nebulised midazolam 0.3mg/kg in children undergoing lower abdominal surgeries
Primary Outcome Measure Information:
Title
level of preoperative anxiety
Description
The level of anxiety of the child during separation from parents according to Parental separation anxiety scale (PSAS), with a 4-point scale as: 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
Time Frame
30 minutes after drug administration
Title
Incidence of emergence delirium
Description
Incidence of emergence delirium, wake up behaviour will be assessed according to Watcha scale where Score is observed values as follows: 0= asleep, 1=calm, 2=crying but can be consoled, 3=crying but cannot be consoled, 4=agitating and thrashing around
Time Frame
immediate postoperative
Secondary Outcome Measure Information:
Title
the level of sedation
Description
The level of sedation when the child first seen in the operating room 30 minutes after sedation using Ramsey sedation scale
Time Frame
30 minutes after drug administration
Title
hemodynamic changes
Description
number of participants experienced any hemodynamic changes if more than 20% change in mean arterial pressure (MAP) and Heart Rate (HR).
Time Frame
perioperative
Title
PONV
Description
Incidence of post-operative nausea and vomiting.
Time Frame
perioperative
Title
recovery time
Description
Recovery time, time between laryngeal mask removal and discharge from recovery room.
Time Frame
up to 2 hours postoperative
Title
total fentanyl use
Description
Total fentanyl use during operation
Time Frame
intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children aged 3-8 years
ASA I&II
Undergoing lower abdominal surgeries for example hernia repair and circumcision
Exclusion Criteria:
Children with chest infection, respiratory disease, cardiac disease
Children with mental or physical disabilities, treatment with sedatives and anticonvulsants
Parental refusal
Allergy to study drugs
Facility Information:
Facility Name
Ainshams University
City
Cairo
ZIP/Postal Code
0000
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M Abokamar, Assistant lecturer
Phone
01095573771
Ext
0000
Email
abokamar157@gmail.com
First Name & Middle Initial & Last Name & Degree
Ashraf E Elagamy, Professor
Phone
01004010962
Ext
000
Email
elagamy_ashraf@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Children Undergoing Lower Abdominal Surgeries
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