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Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03179293
Enrollment
70
Registered
2017-06-07
Start date
2017-07-01
Completion date
2018-06-01
Last updated
2018-11-28

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

Conditions

Emergence Agitation

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.

Interventions

DRUGPropofol

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

DRUGNormal saline

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Emergence Agitation30 min after emergenceThe incidence of EA according to the Watcha scale (defined as a score ≥3 at any time in the 30 min after emergence)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026