Emergence Delirium in Children: Total Intravenous Anesthesia With Propofol and Remifentanil Versus Inhalational Sevoflurane Anesthesia

Summary

Emergence delirium (ED) refers to a wide variety of behavioural disturbances that are commonly seen in children following emergence from anesthesia. ED can potentially be dangerous and have serious consequences for the child such as injury, increased pain, and dislodgement of medical devices, often requiring physical restraint or pharmacological control. Witnessing this behaviour can be stressful for parents, which can negatively affect their interaction with the healthcare system, and their relationship with the child, nursing staff and other healthcare providers. The investigators aim to minimize ED to reduce the distress experienced by patients and their parents. This study will compare the recovery profile of sevoflurane with that of propofol remifentanil and their associated incidence of ED. This study should enable us to determine which form of anesthesia is associated with the fewest incidences of ED in children.

Conditions

• Emergence Delirium

Interventions

DRUG

Propofol

Patients will be anesthetised according to standard induction protocols with propofol/remifentanil intravenously. A laryngeal mask airway (LMA) will be placed by the anesthesiologist, as is usual practice for these cases. A standard dose of fentanyl (1 mcg.kg-1 IV, MAX dose 25 mcg) for postoperative pain and ondansetron (0.1 mg.kg-1 IV, MAX dose 2.5 mg) for PONV prophylaxis will be given to both groups. Dexamethasone will NOT be permitted as an additional antiemetic.

DRUG

sevoflurane

Patients will be anesthetised according to standard induction protocols with sevoflurane by inhalation. A laryngeal mask airway (LMA) will be placed by the anesthesiologist, as is usual practice for these cases. A standard dose of fentanyl (1 mcg.kg-1 IV, MAX dose 25 mcg) for postoperative pain and ondansetron (0.1 mg.kg-1 IV, MAX dose 2.5 mg) for PONV prophylaxis will be given to both groups. Dexamethasone will NOT be permitted as an additional antiemetic.

Sponsors & Collaborators

• University of British Columbia

  lead OTHER

Principal Investigators

• Carolyne Montgomery, MD · University of British Columbia

• Mark Ansermino, MD · University of British Columbia

• Clayton Reichert, MD · University of British Columbia

• Michelle Misse · British Columbia Children's Hospital

• John Chandler · British Columbia Children's Hospital

• Disha Mehta · British Columbia Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

6 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-02-28

Primary Completion

2011-08-31

Completion

2011-08-31

Countries

• Canada

Study Locations