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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032776
Receipt No. R000037392
Scientific Title Deep sedation versus light/moderate sedation for surgical procedure: a systematic review and meta-analysis
Date of disclosure of the study information 2018/12/31
Last modified on 2019/03/13

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Basic information
Public title Deep sedation versus light/moderate sedation for surgical procedure: a systematic review and meta-analysis
Acronym Deep sedation versus light/moderate sedation for surgical procedure
Scientific Title Deep sedation versus light/moderate sedation for surgical procedure: a systematic review and meta-analysis
Scientific Title:Acronym Deep sedation versus light/moderate sedation for surgical procedure
Region
Japan

Condition
Condition Patients who received deep sedation or light/moderate sedation
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To performe a systematic review and meta-analysis of several randomised controlled trials to compare the patients satisfaction of deep sedation with that of light/moderate sedation during surgical procedure.
The aim of this study is to examine patient satisfaction, surgeon satisfaction, oxygen saturation, blood pressure, and heart rate whether deep sedation is superior to light/moderate sedation in surgical procedure.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes patient satisfaction , oxygen saturation, blood pressure, heart rate, time to procedure, recovery time
Key secondary outcomes

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
18 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Inclusion criteria for analysis required that each study be a prospective randomised trial or a comparison between the deep sedation and the light or moderate sedation in surgical procedure.
Key exclusion criteria pediatrics
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Hiroshi Hoshijima
Organization Saitama Medical University Hospital
Division name Anesthesiology
Zip code 350-0495
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
TEL 0492761271
Email hhoshi6@gmail.com

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Hoshijima
Organization Saitama Medical University Hospital
Division name Anesthesiology
Zip code 350-0495
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
TEL 0492761271
Homepage URL
Email hhoshi6@gmail.com

Sponsor
Institute Saitama Medical University Hospital
Institute
Department

Funding Source
Organization Associate of japanese dental anesthesiology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor hokaido university,kanagawa dental university, okayama university, aitigakuin university
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saitama Medical University Hospital
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
Tel 0492761271
Email hhoshi6@gmail.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

Other administrative information
Date of disclosure of the study information
2018 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
2018 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2021 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Two authors independently assessed each article to determine whether it met the inclusion criteria. Disagreements between the authors regarding values or analysis assignments were resolved through discussion. We were careful to avoid including data from duplicate publications. In the case of suspected data discrepancies, we contacted the relevant author directly. Each author also performed independent data abstraction, using standardised data collection forms. Data extracted from eligible studies included the following parameters: oxygen saturation, blood pressure (systoric blood pressure), and heart rate. Deep sedation was defined as modified observer's alertness/sedation scale < 2, Paspatis), ramsay sedation scale > 4, Bispectral Index (BIS) < 70.

Management information
Registered date
2018 Year 05 Month 30 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037392

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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