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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001929
Receipt No. R000002350
Scientific Title Magnesium sulphate attenuates arterial blood pressure increase during laparoscopic cholecystectomy under pneumoperitoneum
Date of disclosure of the study information 2009/05/01
Last modified on 2009/05/01

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Basic information
Public title Magnesium sulphate attenuates arterial blood pressure increase during laparoscopic cholecystectomy under pneumoperitoneum
Acronym Magnesium sulphate during laparoscopic cholecystectomy
Scientific Title Magnesium sulphate attenuates arterial blood pressure increase during laparoscopic cholecystectomy under pneumoperitoneum
Scientific Title:Acronym Magnesium sulphate during laparoscopic cholecystectomy
Region
Asia(except Japan)

Condition
Condition Patients scheduled for elective laparoscopic cholecystectomy under CO2 pneumoperitoneum
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigat the ability of magnesium sulphate to control cardiovascular disturbances and neurohumoral responses in patients undergoing elective laparoscopic cholecystectomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Hemodynamic stability during intraoperative period
Key secondary outcomes neurohumoral responses in patients undergoing laparoscopic cholecystectomy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 0.5 ml/kg of 10% magnesium sulphate (50 mg/kg) intravenously injection before pneumoperitoneum
Interventions/Control_2 0.5 ml/kg saline intravenously injection before pneumoperitoneum
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
65 years-old >=
Gender Male and Female
Key inclusion criteria ASA physical status 1 patients scheduled for elective laparoscopic cholecystectomy under CO2 pneumoperitoneum
Key exclusion criteria Patients with following criteria
1. hypermagnesaemia
2. a known allergy to magnesium sulphate 3. any degree of heart block hypertension, diabetes mellitus, cardiovascular diseases or kidney dysfunction
4. acute cholecystitis
5. an endocrine or metabolic disease
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Deok-hee Lee
Organization College of Medicine, Yeungnam University
Division name Department of Anaesthesiology and Pain Medicine
Zip code
Address Department of Anaesthesiology and Pain Medicine, College of Medicine, Yeungnam University, 317-1 Daemyung Dong, Namgu, Daegu 705-717, Republic of Korea
TEL 82-53-620-3368
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization College of Medicine, Yeungnam University
Division name Department of Anaesthesiology and Pain Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Chunma medical research foundation
Institute
Department

Funding Source
Organization Chunma medical research foundation
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 05 Month 01 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 Completed
Date of protocol fixation
2005 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2005 Year 07 Month 01 Day
Last follow-up date
2007 Year 06 Month 01 Day
Date of closure to data entry
2007 Year 07 Month 01 Day
Date trial data considered complete
2007 Year 10 Month 01 Day
Date analysis concluded
2008 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 05 Month 01 Day
Last modified on
2009 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002350

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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