Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation

Emergence Agitation Clinical Trial

Official title:

Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation in Genito-urinary Paediatric Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03179293
• Other study ID #: propofol after sevo
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: November 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

Inclusion Criteria:

1. Children Aged 3 - 8 years

2. ASA (I - II)

3. Genito-urinary Surgeries: hernia, varicocele, etc.

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.

Related Conditions & MeSH terms

• Emergence Agitation
• Emergence Delirium
• Psychomotor Agitation

Intervention

Drug:
• 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
• Normal saline
Normal saline will be administered manually over the next 3 min prior to the patient leaving the OR

Locations

Country	Name	City	State
Egypt	Assiut University hospital	Assiut	Asyut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emergence Agitation	The incidence of EA according to the Watcha scale (de?ned as a score =3 at any time in the 30 min after emergence)	30 min after emergence
Primary	Emergence Agitation	The incidence of EA according to the Paediatric Emergence Anaesthesia Delirium (PAED) scale (de?ned as a score >12 at any time in the 30 min after emergence )	30 min after emergence