Back to resultsTransition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation
Primary Purpose
Emergence Agitation
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Propofol
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Emergence Agitation
Eligibility Criteria
Inclusion Criteria:
- Children Aged 3 - 8 years
- ASA (I - II)
- Genito-urinary Surgeries: hernia, varicocele, etc.
Exclusion Criteria:
- Patients or parental refusal
- Allergy to Propofol or egg products; or a family history of malignant hyperthermia
- Operating time more than 60 minutes
- Performance of any other procedure under the same anaesthetic
- Presence of co-morbidities or congenital anomalies
- mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.
Sites / Locations
- Assiut University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Propofol
Control
Arm Description
propofol 1 mg/kg IV bolus will be given to the patient with a further 2 mg/kg administered manually over the next 3 min prior to the patient leaving the OR
Normal saline will be administered IV over the next 3 min prior to the patient leaving the OR
Outcomes
Primary Outcome Measures
Emergence Agitation
The incidence of EA according to the Watcha scale (defined as a score ≥3 at any time in the 30 min after emergence)
Emergence Agitation
The incidence of EA according to the Paediatric Emergence Anaesthesia Delirium (PAED) scale (defined as a score >12 at any time in the 30 min after emergence )
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03179293
Brief Title
Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation
Official Title
Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation in Genito-urinary Paediatric Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut 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
5. Study Description
Brief Summary
The aim of this randomized double-blinded study is to determine whether transition to propofol for 3 min at the end of sevoflurane anaesthesia reduces the incidence of EA in children undergoing genito-urinary paediatric surgeries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Agitation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
propofol 1 mg/kg IV bolus will be given to the patient with a further 2 mg/kg administered manually over the next 3 min prior to the patient leaving the OR
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Normal saline will be administered IV over the next 3 min prior to the patient leaving the OR
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
propofol 1 mg/kg IV bolus will be given to the patient with a further 2 mg/kg administered manually over the next 3 min prior to the patient leaving the OR
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Normal saline will be administered manually over the next 3 min prior to the patient leaving the OR
Primary Outcome Measure Information:
Title
Emergence Agitation
Description
The incidence of EA according to the Watcha scale (defined as a score ≥3 at any time in the 30 min after emergence)
Time Frame
30 min after emergence
Title
Emergence Agitation
Description
The incidence of EA according to the Paediatric Emergence Anaesthesia Delirium (PAED) scale (defined as a score >12 at any time in the 30 min after emergence )
Time Frame
30 min after emergence
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children Aged 3 - 8 years
ASA (I - II)
Genito-urinary Surgeries: hernia, varicocele, etc.
Exclusion Criteria:
Patients or parental refusal
Allergy to Propofol or egg products; or a family history of malignant hyperthermia
Operating time more than 60 minutes
Performance of any other procedure under the same anaesthetic
Presence of co-morbidities or congenital anomalies
mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.
Facility Information:
Facility Name
Assiut University hospital
City
Assiut
State/Province
Asyut Governorate
ZIP/Postal Code
11111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation
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