UMIN-CTR Clinical Trial

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
Email	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
Email	bglim9205@korea.ac.kr

Sponsor
Institute	Korea University Guro Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044514