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

June 30, 2017 updated by: Carolyne Montgomery, University of British Columbia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose:

In children, both propofol-only anesthesia maintenance infusions and single postoperative propofol boluses have been shown to be efficacious at reducing ED when compared with sevoflurane only [13, 17]. Methodological problems in these studies include: the administration of sedative premedications, ED provocative study designs that do not reflect reasonable clinical practice with sevoflurane, and the use of inadequately validated ED outcome tools.

Based on our extensive institutional experience with TIVA, we believe that this technique is superior to sevoflurane with respect to the incidence of ED. However, this clinical impression has never been validated in an appropriately robust investigation, and sevoflurane remains the pediatric anesthetic of choice for most other North American pediatric anesthesiologists.

Hypotheses:

  1. The use of total intravenous anesthesia (TIVA), rather than sevoflurane (SEVO) will reduce incidence of ED, as measured by the Pediatric Anesthesia Emergence Delirium (PAED) scale.
  2. The use of TIVA will not result in longer times to laryngeal mask airway removal and post anesthetic care unit (PACU) discharge when compared to SEVO.

Objectives:

  1. To compare the incidence of ED between SEVO and TIVA anesthesia in children
  2. To compare times for recovery from anesthesia between the TIVA and SEVO groups

Research Method:

Recruitment of subjects: With institutional review board approval, and with written informed consent, we will recruit children, ages 2-6 years, undergoing elective strabismus surgery, a relatively minor eye procedure.

Each child will be randomly assigned to one of two groups to receive either TIVA or SEVO. We will exclude children with ASA status IV-V, developmental delay, neurological injury, psychiatric diagnosis, abnormal lipid or carbohydrate metabolism, postoperative nausea or vomiting, Body Mass Index >30, severe anxiety in the pre-operative period requiring sedative premedication or complex medical conditions.

Study design: This study is a randomized, masked clinical trial comparing induction and maintenance of anesthesia with TIVA to SEVO. Every effort will be made to maximize the masking of the observer. All patients will be scored by the Research Fellow, Dr. John Chandler, who will be masked to the anesthetic technique. To evaluate the pre and postoperative state of children we will use of the following scoring tools:

  1. The Induction Compliance Checklist (ICC) will be used to evaluate patient preoperative behaviour
  2. The PAED scale will be used to assess patients for ED in the PACU.
  3. Pain will be assessed postoperatively by means of the face, legs, activity, cry, consolability (FLACC) score currently used in the PACU

Statistical Analysis:

Patients with a PAED score of ≥ 10 will be classified as experiencing ED. Continuous data (weight, BMI) will be analyzed with t-tests and ordinal data (FLACC, PAED, ICC) with Mann-Whitney U tests.

The primary hypothesis will be examined by means of a contingency table and Fisher's exact test.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • British Columbia Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
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.
ACTIVE_COMPARATOR: 2
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of emergence delirium
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Study Director: Clayton Reichert, MD, University of British Columbia
  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

April 20, 2009

First Submitted That Met QC Criteria

April 21, 2009

First Posted (ESTIMATE)

April 22, 2009

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H08-02470

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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