Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation

NCT ID: NCT03179293

Last Updated: 2018-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2018-06-01

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.

Conditions

Emergence Agitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: 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

Control

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Normal saline

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Samy Abbas

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University hospital

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Other Identifiers

propofol after sevo

Identifier Type: -

Identifier Source: org_study_id