UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030901 |
|---|---|
| Receipt number | R000035285 |
| Scientific Title | Effect of perioperative intravenous dextrose administration in improving postoperative nausea and vomiting in adult patients: A meta-analysis with trial sequential analysis |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2019/07/23 09:10:03 |
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Basic information
Public title
Effect of perioperative intravenous dextrose administration in improving postoperative nausea and vomiting in adult patients: A meta-analysis with trial sequential analysis
Acronym
Dextrose for preventing PONV
Scientific Title
Effect of perioperative intravenous dextrose administration in improving postoperative nausea and vomiting in adult patients: A meta-analysis with trial sequential analysis
Scientific Title:Acronym
Dextrose for preventing PONV
Region
| Japan |
Condition
Condition
Patients who undergo elective surgery under general anesthesia
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of intravenous administration of dextrose on postoperative nausea and vomiting (PONV) was controversial. The aim of this study is to investigate the effect of intravenous dextrose on PONV.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome from the present meta-analysis is the incidence of PONV during postoperative 24 hours.
Key secondary outcomes
The secondary outcomes are the need for rescue antiemetics, incidence of hyperglycemia, postoperative blood glucose level.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We search for all randomized controlled trials that tested the effect of intravenous dextrose compared with a placebo on PONV.
Key exclusion criteria
We exclude data case reports, comments or letters to the editor, reviews, and animal studies. Eligibility is not restricted by language, type of surgery, anesthetic technique, or patient age.
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Mihara |
Organization
Yokohama City University Hospital
Division name
Department of Anesthesiology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama city
TEL
045-787-2800
miharaxxxtotoro@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Mihara |
Organization
Yokohama City University Hospital
Division name
Department of Anesthesiology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama city
TEL
045-787-2800
Homepage URL
miharaxxxtotoro@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Hospital
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
NA
Address
NA
Tel
NA
NA
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
| 2018 | Year | 08 | Month | 01 | 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
| 2018 | Year | 01 | Month | 19 | Day |
Date of IRB
| 1977 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 07 | Month | 10 | Day |
Other
Other related information
The study protocol is attached in this pre-registration or can be seen at http://www-user.yokohama-cu.ac.jp/~masuika/protocol/
MEDLINE, CENTRAL, Embase, and Web of Science are searched. Further, we conduct a search of clinicaltrials.gov and the UMIN Clinical Trials Registry.
Two authors independently scan the titles and abstracts of reports identified by the variety of search strategies described above. The articles that meet the inclusion criteria are assessed separately by two authors, and any discrepancies are resolved through discussion.
Continuous data are summarized using mean difference with a 95% confidence interval. Dichotomous data are summarized using risk ratio with a 95% CI. Heterogeneity is quantified with the I2 statistic. We consider that significant heterogeneity existed when the I2 statistic exceeded 50%. We plan to conduct subgroup analysis according to the following predefined factors when the I2 statistic exceeded 50%: presence or absence of prophylactic antiemetics, less than 250 ml of 5% dextrose or not, or type of surgery. We use the random effect model to combine the results. For our primary outcome, trial sequential analysis are performed to correct for random error and repetitive testing of accumulating and sparse data. Risk of type 1 error is maintained at 5% with a power of 90%. The RR of the incidence of PONV of 0.75 (i.e., 25% relative risk reduction) was considered clinically meaningful.
Management information
Registered date
| 2018 | Year | 01 | Month | 20 | Day |
Last modified on
| 2019 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035285
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
