UMIN-CTR Clinical Trial

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
Email	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
Email	hani_taman@yahoo.com

Sponsor
Institute	MANSOURA FACULTY OF MEDICIN,MANSOURA UNIVERSITY, MANSOURA, EGYPT
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049253