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Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation

A

Assiut University

Status and phase

Completed
Phase 4

Conditions

Emergence Agitation

Treatments

Drug: Normal saline
Drug: Propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT03179293
propofol after sevo

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

3 to 8 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups, including a placebo group

Propofol
Active Comparator group
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
Treatment:
Drug: Propofol
Control
Placebo Comparator group
Description:
Normal saline will be administered IV over the next 3 min prior to the patient leaving the OR
Treatment:
Drug: Normal saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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