UMIN-CTR Clinical Trial

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
Email	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
Email	miharaxxxtotoro@yahoo.co.jp

Sponsor
Institute	Yokohama City University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035285