UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011841 |
|---|---|
| Receipt number | R000013841 |
| Scientific Title | Effect of melatonin on preventing emergence agitation after general anesthesia: systematic review and meta-analysis |
| Date of disclosure of the study information | 2013/09/24 |
| Last modified on | 2014/09/23 11:29:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of melatonin on preventing emergence agitation after general anesthesia: systematic review and meta-analysis
Acronym
Effect of melatonin on preventing emergence agitation after general anesthesia: systematic review and meta-analysis
Scientific Title
Effect of melatonin on preventing emergence agitation after general anesthesia: systematic review and meta-analysis
Scientific Title:Acronym
Effect of melatonin on preventing emergence agitation after general anesthesia: systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Children who are scheduled to undergo surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether melatonin is effective to prevent emergence agitation in children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of the meta-analysis is the effect of melatonin compared with placebo or active drugs such as midazolam for prevention of emergence agitation in children. The side effects of melatonin are also analyzed as the primary outcome.
Key secondary outcomes
The secondary outcome is the effect of melatonin against the children's anxiety before anesthesia.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All trials that included a component comparing melatonin with placebo or active drugs as a premedication that reported the incidence of emergence agitation after general anesthesia in children are included in this study. We consider melatonin receptor agonists such as ramelteon or tasimelteon as melatonin. Eligibility is not restricted by language, type of surgery, or anesthesia technique.
Key exclusion criteria
We exclude studies in which the incidence of emergence agitation (or emergence delirium) was not evaluated using specific assessment tool such as Pediatric Anesthesia Emergence Delirium (PAED) scale, Aono's scale, or any other adequate scales. We also exclude case reports, reviews, and animal studies.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Mihara |
Organization
Kanagawa Children's Medical Center
Division name
Department of Anesthesiology
Zip code
Address
Kanagawa Children's Medical Center, Mutsukawa 2-138-4, Minami-ku, Yokohama Postcode 232-8555 Japan
TEL
045-711-2531
miharaxxxtotoro@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Mihara |
Organization
Kanagawa Children's Medical Center
Division name
Department of Anesthesiology
Zip code
Address
Kanagawa Children's Medical Center, Mutsukawa 2-138-4, Minami-ku, Yokohama, Japan
TEL
045-711-2531
Homepage URL
miharaxxxtotoro@yahoo.co.jp
Sponsor or person
Institute
Kanagawa Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 08 | Month | 01 | Day |
Other
Other related information
We search MEDLINE, CENTRAL, Embase, Web of Science, clinicaltrials.gov and the UMIN clinical trial registry. Two authors independently assess for inclusion all of the studies that are identified for potential inclusion as a result of the search strategy. A data collection sheet is created and included data on: diagnosis tool for EA; dose of melatonin; type of control; number of patients in melatonin group and control group; result of agitation scale in melatonin group and control group; number of reported incidents of EA in melatonin group and control group; and adverse effects of melatonin. When EA was classified according to severity, we extract the data from the severe category. When EA was assessed several time points, we extract the data evaluated immediately after emergence. When a study included multiple midazolam groups with different doses, we extract the data of 0.5 mg/kg of midazolam. When a study included multiple melatonin groups with different doses, we extracted the data separately and both the number of events and the total number of participants in control group were divided up. We assess the risk of bias as described by the Cochrane Handbook for Systematic Reviews of Interventions. Dichotomous data are summarised using risk ratio with a 95% confidence interval. Heterogeneity is quantified with the I2 statistic. We use the random-effects model to combine the results of the studies. Forest plots are used to graphically represent and evaluate the effects of treatment. Publication bias is assessed using a funnel plot when the number of studies was more than 9. Sensitivity analyses are performed restricting to studies to which a low risk of bias was attributed.We considered midazolam premedication as placebo because midazolam premedication was reported to have no effect in preventing emergence agitation. We conducted a meta-regression analysis to confirm whether the pooled results would change according to the type of control and dose of melatonin.
Management information
Registered date
| 2013 | Year | 09 | Month | 23 | Day |
Last modified on
| 2014 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013841
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
