UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032776 |
|---|---|
| Receipt number | 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 | 2022/05/23 11:33:50 |
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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
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
hhoshi6@gmail.com
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
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
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
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
658
Results
5 articles satisfied the inclusion criteria inthis study. Patient satisfaction was significantly higher in those who received deep sedation compared with light/moderate sedation
Results date posted
| 2022 | Year | 05 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The inclusion criteria were a prospective randomized study design, studies that compared deep, light or moderate sedation, studies that examined patient satisfaction, vital signs, procedure time, and recovery time. We also included studies that examined procedures not requiring tracheal intubation in adult patients. The exclusion criterion was a stay in the intensive care unit.
Participant flow
A comprehensive literature search was performed using MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE and Scopus. The following strategy was devised for the PubMed search: (deep sedation"[MeSH Terms] OR ("deep"[All Fields] AND "sedation"[All Fields]) OR "deep sedation"[All Fields]) AND (Clinical Trial[ptyp] AND "humans"[MeSH Terms]) (Supplemental 1). A manual search of the references listed in the reports and reviews was also performed. There were no restrictions regarding the language of the article or publication type. The most recent search was performed in September 2020.
Adverse events
none
Outcome measures
The primary outcome of this systematic review was to determine whether deep sedation improved patient satisfaction compared to light/moderate sedation. To evaluate patient satisfaction, we extracted information from scoring evaluations of patient satisfaction after surgery. The patient satisfaction analyzed the number of people who compared the number of excellent or highly satisfied and others. The secondary outcome was to investigate whether deep sedation is safe compared to light/moderate sedation. Data extracted from eligible studies included values of oxygen saturation, systolic blood pressure, and heart rate. As the tertiary outcome, we compared procedure time and recovery time between deep sedation and light/moderate sedation.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 01 | Day |
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
| 2022 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037392
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