Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation

NCT03179293 | Completed Phase 4

• 1 other identifier: propofol after sevo
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Emergence Agitation

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

  30 min after emergence

• Emergence Agitation

  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 )

  30 min after emergence

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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

Drug: Propofol

Control

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

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

Propofol

Normal saline DRUG

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

Control

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children Aged 3 - 8 years
• ASA (I - II)
• Genito-urinary Surgeries: hernia, varicocele, etc.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospital

Asyut, Asyut Governorate, 11111, Egypt

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Propofol; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 3, 2017
• First Posted: June 7, 2017
• Study Start: July 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: November 28, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)