UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of different levels of elevated artificial pneumoperitoneum pressure on the cerebral perfusion pressure during laparoscopic-cholycystectomy.
Title of the study (Brief title)	The effect of different levels of elevated artificial pneumoperitoneum pressure on the cerebral perfusion pressure during laparoscopic-cholycystectomy.
Region	Africa

Condition
Condition	double blinded comparative study
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	improve the safety of the introduction of the first trocar and investigate the changes in cerebral perfusion pressure and cerebral oxygen extraction caused by high transient pneumo-peritoneum pressures for short periods of time
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Phase IV

Assessment
Primary outcomes	Determine the range of safety of inflation of intrapretoneal pressure on cerebral perfusion pressure
Key secondary outcomes	Improve the outcome after laparoscopic surgery.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	inflating the peritoneal cavity up to 20mmHg
Interventions/Control_2	Inflating the peritoneal cavity up to 12mmHg
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	20 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	1- elective laparoscopic cholycystectomy 2- ASA I or ASA II 3- between 20 and 45 years 4- no history of abdominal surgery on organs 5- body mass index less than 35
Key exclusion criteria	1- history of smoking 2- cardiovascular, respiratory, neurologic, renal, liver, or hormonal disease
Target sample size	60

Research contact person
Name of lead principal investigator	HANI I TAMAN
Organization	MANSOURA FACULTY OF MEDICINE, MANSOURA, EGYPT
Division name	ANAESTHESIOLOGY DEPARTMENT
Address	12, ELGOMHORIA STREET, MANSOURA, EGYPT
TEL	020502261333
Email	mfm@mans.edu.eg

Public contact
Name of contact person	HANI IBRAHIM TAMAN
Organization	MANSOURA FACULTY OF MEDICINE
Division name	ANAESTHESIOLOGY DEPARTMENT
Address	23 GEHAN STREET, MANSOURA, EGYPT
TEL	020507484774
Homepage URL
Email	hani_taman@yahoo.com

Sponsor
Institute	MANSOURA FACULTY OF MEDICINE, MANSOURA, EGYPT
Institute
Department

Funding Source
Organization	MANSOURA FACULTY OF MEDICINE
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 01 Day
Anticipated trial start date	2014 Year 11 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 03 Month 19 Day
Last modified on	2018 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036303