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

NCT00885443 | Completed

• 1 other identifier: H08-02470
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

propofol; sevoflurane; pediatric; emergence delirium; Induction of sedation

Outcome Measures

Primary Outcomes (1)

• Occurrence of emergence delirium

  1 day

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Propofol

2

ACTIVE COMPARATOR

Drug: sevoflurane

Interventions

Propofol DRUG

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.

1

sevoflurane DRUG

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.

2

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children having general anesthesia for elective strabismus or other suitable minor eye surgery
• Age ≥ 2 and ≤ 6 years
• ASA I-II
• Appropriate procedure and patient for LMA airway management

You may not qualify if:

• Developmental delay or neurological injury
• Psychotropic medications or psychiatric diagnosis
• Abnormal lipid or carbohydrate metabolism
• Deviations from the anesthesia protocol including an inability to secure pre-anesthetic intravenous access in the TIVA group
• Severe anxiety in the pre-operative period requiring sedative. premedication according to the staff anesthesiologist's and family's assessment
• Patients experiencing pain requiring analgesia, postoperative nausea or vomiting (PONV) during the study period
• Patients seen in the pre-anesthetic assessment clinic, due to habituation to hospital environment
• Growth chart percentiles of \< 3% or \> 97%

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Propofol; Sevoflurane

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; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Carolyne Montgomery, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Mark Ansermino, MD

  University of British Columbia

  STUDY DIRECTOR

• Clayton Reichert, MD

  University of British Columbia

  STUDY DIRECTOR

• Michelle Misse

  British Columbia Children's Hospital

  STUDY CHAIR

• John Chandler

  British Columbia Children's Hospital

  STUDY CHAIR

• Disha Mehta

  British Columbia Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 22, 2009
• Study Start: February 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 5, 2017

Record last verified: 2017-05

Locations

CA (1)