UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039035 |
|---|---|
| Receipt number | R000044514 |
| Scientific Title | The effect of dexamethasone on sugammadex reversal of rocuronium-induced neuromuscular blockade in surgical patients undergoing general anesthesia: A systematic review and meta-analysis |
| Date of disclosure of the study information | 2019/12/31 |
| Last modified on | 2019/12/30 22:00:57 |
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Basic information
Public title
The effect of dexamethasone on sugammadex reversal of rocuronium-induced neuromuscular blockade in surgical patients undergoing general anesthesia: A systematic review and meta-analysis
Acronym
The effect of dexamethasone on sugammadex reversal of rocuronium-induced neuromuscular blockade in surgical patients undergoing general anesthesia: A systematic review and meta-analysis
Scientific Title
The effect of dexamethasone on sugammadex reversal of rocuronium-induced neuromuscular blockade in surgical patients undergoing general anesthesia: A systematic review and meta-analysis
Scientific Title:Acronym
The effect of dexamethasone on sugammadex reversal of rocuronium-induced neuromuscular blockade in surgical patients undergoing general anesthesia: A systematic review and meta-analysis
Region
| Asia(except Japan) |
Condition
Condition
Reversal of neuromuscular blockade during general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of dexamethasone on sugammadex reversal of rocuronium-induced neuromuscular blockade in surgical patients undergoing general anesthesia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the time to recovery after sugammadex administration (= time to recovery of the train-of-four [TOF] ratio to 0.9 after sugammadex administration)
Key secondary outcomes
the time to extubation after sugammadex administration, and incidence of postoperative nausea and vomiting (PONV) or other postoperative adverse events
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
| 1 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients undergoing administration of sugammadex for reversal of neuromuscular blockade after surgery under general anesthesia patients
Key exclusion criteria
patients not given IV dexamethasone during general anesthesia and sugammadex for reversal of neuromuscular blockade after surgery.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Heezoo |
| Middle name | |
| Last name | Kim |
Organization
Korea University Guro Hospital
Division name
Anesthesiology and Pain Medicine
Zip code
08308
Address
148, Gurodong-ro, Guro-gu, Seoul, South Korea
TEL
82-2-2626-1437
kimheezoo@hotmail.com
Public contact
Name of contact person
| 1st name | Byung Gun |
| Middle name | |
| Last name | Lim |
Organization
Korea University Guro Hospital
Division name
Anesthesiology and Pain Medicine
Zip code
08308
Address
148, Gurodong-ro, Guro-gu, Seoul, South Korea
TEL
82-2-2626-3231
Homepage URL
bglim9205@korea.ac.kr
Sponsor or person
Institute
Korea University Guro Hospital
Institute
Department
Personal name
Funding Source
Organization
Korea University Guro Hospital
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
Korea University Guro Hospital Institutional Review Board, Seoul, Republic of Korea
Address
Korea University Guro Hospital, 148, Gurodong-ro, Guro-gu, Seoul 08308, Republic of Korea
Tel
82-2-2626-1632
kughirb@naver.com
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
Korea University Guro Hospital
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 12 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study methodology is based on the Cochrane Review Methods. We will search MEDLINE, EMBASE, and the Cochrane Controlled Clinical Trials Register Database etc. using the Medical Subject Headings (MeSH) and free text terms to identify clinical trials that investigated the effect of dexamethasone on sugammadex reversal of rocuronium-induced neuromuscular blockade in surgical patients undergoing general anesthesia. Two reviewers will independently assess each study according to the pre-defined inclusion criteria and extract data from each study using the pre-specified data extraction form. We will use RevMan version 5.2 and STATA version 13.0 for the meta-analyses. The data from each study will be combined using the fixed-effect or random-effect model to calculate the pooled risk ratio, standardized or weighted mean difference and 95% confidence interval. Subgroup and sensitivity analysis will be performed.
Management information
Registered date
| 2019 | Year | 12 | Month | 30 | Day |
Last modified on
| 2019 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044514
