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Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery

NCT ID: NCT01938300

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-10-31

Brief Summary

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Magnesium sulphate is given to the patients during the colorectal cancer surgery under the hypothesis that it would attenuate the postoperative hypercoagulability. The investigators intend to characterize the changes of coagulation in colorectal cancer patients by using the point-of-care device after the infusion of magnesium sulphate.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Magnesium

Magnesium sulfate infusion during a operation period.

Infusion regimen:

1. Bolus 50 mg/kg of magnesium sulfate in 100 ml normal saline over 15 minutes
2. Infusion 15 mg/kg/h of magnesium sulfate throughout the operation

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

Control

administration of normal saline as a same volume of magnesium sulphate as a same method.

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Interventions

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Magnesium Sulfate

Intervention Type DRUG

Normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The patients undergoing a laparoscopic colorectal cancer surgery

Exclusion Criteria

* Renal disease
* Hepatic disease
* Neuromuscular disease
* Coagulation disorder
* Cardiopulmonary disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Seok Na

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Mg-ROTEM-colorectal ca

Identifier Type: -

Identifier Source: org_study_id