UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043142 |
|---|---|
| Receipt number | R000049253 |
| Scientific Title | The impact of sevoflurane and propofol anesthetic induction on bag mask ventilation in surgical patients with high BMI. |
| Date of disclosure of the study information | 2021/01/27 |
| Last modified on | 2021/01/27 10:51:14 |
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Basic information
Public title
The impact of sevoflurane and propofol anesthetic induction on bag mask ventilation in surgical patients with high BMI.
Acronym
The impact of sevoflurane and propofol anesthetic induction on bag mask ventilation in surgical patients with high BMI.
Scientific Title
The impact of sevoflurane and propofol anesthetic induction on bag mask ventilation in surgical patients with high BMI.
Scientific Title:Acronym
The impact of sevoflurane and propofol anesthetic induction on bag mask ventilation in surgical patients with high BMI.
Region
| Africa |
Condition
Condition
finalizing manuscript
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to compare the effect of both propofol and sevoflurane on the efficacy of bag mask ventilation during anesthetic induction in obese patients with low physiological reserve
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
concluding weather propofol or sevoflurane is superior in management of bag mask ventilation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
1 group received propofol for induction of anaesthesia, second group receive sevoflurane for induction of anaesthesia
Interventions/Control_2
observation of risk factors of difficult BMV in obese patients.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA physical score of I or II
predicted to be difficult for bag mask ventilation
scheduled for elective operations using general anaesthesia
Key exclusion criteria
severe systemic comorbidities
ASA physical score > II
history of difficult intubation
refuse to participate in the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | HANI |
| Middle name | IBRAHIM |
| Last name | TAMAN |
Organization
MANSOURA FACULTY OF MEDICIN,MANSOURA UNIVERSITY, MANSOURA, EGYPT
Division name
ANAETHESIA AND SURGICAL INTENSIVE CARE DEPARTMENT
Zip code
53000
Address
11 ELGOMHORIA STREET, MANSOURA, ALDAKAHLIYA, EGYPT
TEL
04407534268934
hani_taman@yahoo.com
Public contact
Name of contact person
| 1st name | HANI |
| Middle name | IBRAHIM |
| Last name | TAMAN |
Organization
MANSOURA FACULTY OF MEDICIN,MANSOURA UNIVERSITY, MANSOURA, EGYPT
Division name
ANAETHESIA AND SURGICAL INTENSIVE CARE DEPARTMENT
Zip code
53000
Address
11 ELGOMHORIA STREET, MANSOURA, ALDAKAHLIYA, EGYPT
TEL
04407534268934
Homepage URL
hani_taman@yahoo.com
Sponsor or person
Institute
MANSOURA FACULTY OF MEDICIN,MANSOURA UNIVERSITY, MANSOURA, EGYPT
Institute
Department
Personal name
Funding Source
Organization
MANSOURA FACULTY OF MEDICIN,MANSOURA UNIVERSITY, MANSOURA, EGYPT
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
INSTITUTIONAL REVIEW BOARD, MANSOURA FACULTY OF MEDICIN,MANSOURA UNIVERSITY
Address
03 ALGOMHORIA STREET, MANSOURA, ALDAKAHLIYA, EGYPT
Tel
+20502202773
IRB.MFM@hotmail.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
| 2021 | Year | 01 | Month | 27 | 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
200
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
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 27 | Day |
Last modified on
| 2021 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049253
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
