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

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 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


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

Value
https://center6.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