Skip to main content
OpenTrials
Completed

NCT Number: NCT03179293

Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Emergence Agitation Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Assiut University hospital

Asyut, Asyut Governorate, 11111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol

Drug

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

Drug

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

Primary outcomes

  1. Emergence Agitation

    Time frame: 30 min after emergence

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

  2. Emergence Agitation

    Time frame: 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 )

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2017
Registry last updated
Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.