Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation

Phase 4

Completed

• Conditions: Emergence Agitation
• Interventions: Drug: Propofol; Drug: Normal saline

• Registration Number: NCT03179293
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-03
• Study First Submitted QC: 2017-06-06
• Study First Posted: 2017-06-07
• Study Start: 2017-07-01
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-26
• Last Update Posted: 2018-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Children Aged 3 - 8 years
2. ASA (I - II)
3. Genito-urinary Surgeries: hernia, varicocele, etc.

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Exclusion Criteria

1. Patients or parental refusal
2. Allergy to Propofol or egg products; or a family history of malignant hyperthermia
3. Operating time more than 60 minutes
4. Performance of any other procedure under the same anaesthetic
5. Presence of co-morbidities or congenital anomalies
6. mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	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
Control	Normal saline	Normal saline will be administered IV over the next 3 min prior to the patient leaving the OR

Primary Outcome Measures

Name	Time	Method
Emergence Agitation	30 min after emergence	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 )

Trial Locations

Locations (1)

Assiut University hospital; 🇪🇬 Assiut, Asyut Governorate, Egypt