UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001929 |
|---|---|
| Receipt number | 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 17:27:49 |
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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
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
Sponsor or person
Institute
Chunma medical research foundation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002350
