Emergence DeliriumNCT00885443
Emergence Delirium in Children: Total Intravenous Anesthesia With Propofol and Remifentanil Versus Inhalational Sevoflurane Anesthesia
A study testing Propofol and sevoflurane in people with Emergence Delirium, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- Propofol and sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
About this study
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.
Read the 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:
- 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.
- 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:
- To compare the incidence of ED between SEVO and TIVA anesthesia in children
- 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:
- The Induction Compliance Checklist (ICC) will be used to evaluate patient preoperative behaviour
- The PAED scale will be used to assess patients for ED in the PACU.
- 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.
- Conditions
- Emergence Delirium
- Being tested
- Propofol, sevoflurane
- Keywords
- propofol, sevoflurane, pediatric, emergence delirium, Induction of sedation
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
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.
sevofluraneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Propofol |
| 2 | Active comparator | Not described Receives: Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of emergence delirium
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyne Montgomery, University of British Columbia
- Investigators
- Carolyne Montgomery, MD, Principal investigator, University of British ColumbiaMark Ansermino, MD, Study director, University of British ColumbiaClayton Reichert, MD, Study director, University of British ColumbiaMichelle Misse, Study chair, British Columbia Children's HospitalJohn Chandler, Study chair, British Columbia Children's HospitalDisha Mehta, Study chair, British Columbia Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885443
- Sponsor's protocol ID
- H08-02470
- Status last verified
- May 2017
- First submitted
- 20 Apr 2009
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergence Delirium in Children: Total Intravenous Anesthesia With Propofol and Remifentanil Versus Inhalational Sevoflurane Anesthesia
- ClinicalTrials.gov ID
- NCT00885443
- Acronym / sponsor ID
- H08-02470
- Conditions
- Emergence Delirium
- Keywords
- propofol, sevoflurane, pediatric, emergence delirium, Induction of sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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:
- To compare the incidence of ED between SEVO and TIVA anesthesia in children
- 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:
- The Induction Compliance Checklist (ICC) will be used to evaluate patient preoperative behaviour
- The PAED scale will be used to assess patients for ED in the PACU.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Propofol |
| 2 | Active comparator | Drug: sevoflurane |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolPatients 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 | 1 |
| sevofluranePatients 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. | Drug | 2 |
Primary outcome
Occurrence of emergence delirium
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyne Montgomery, MD principal investigator
University of British Columbia
Mark Ansermino, MD study director
University of British Columbia
Clayton Reichert, MD study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and sevoflurane in people with Emergence Delirium, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of emergence delirium (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2017.