UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011866
Receipt number R000013873
Scientific Title Effects of magnesium sulphate on attenuation of the pain caused by propofol intravenous injection and anesthetic requirements: A Randomized Controlled Trial
Date of disclosure of the study information 2013/09/30
Last modified on 2015/09/01 14:12:27

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Basic information

Public title

Effects of magnesium sulphate on attenuation of the pain caused by propofol intravenous injection and anesthetic requirements: A Randomized Controlled Trial

Acronym

Multimodal Effects of magnesium for general anesthesia

Scientific Title

Effects of magnesium sulphate on attenuation of the pain caused by propofol intravenous injection and anesthetic requirements: A Randomized Controlled Trial

Scientific Title:Acronym

Multimodal Effects of magnesium for general anesthesia

Region

Japan


Condition

Condition

Healthy adult patients undergoing elective surgery

Classification by specialty

Anesthesiology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We investigate the effects of magnesium sulfate on attenuation of the pain caused by propofol intravenous injection. Further, stabilization of the concentration of propofol for achieving hypnosis, the effect of promoting the expression of muscle relaxants, suppression of postoperative shivering, the effect of postoperative analgesia, are compared with the saline group.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

1)vascular pain with propofol
2)vascular pain with magnesium
3)time to asleep onset with propofol 4)concentration of propofol at the time of conscious loss

Key secondary outcomes

1)frequency of shivering
2)postoperative pain
3)analgesic requirements
4)muscle relaxant requirement during surgery
5)time to onset of muscle relaxant
6)time to awake from anesthesia
7)hemodynamic changes at the induction of general anesthesia


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

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

Treatment

Type of intervention

Medicine

Interventions/Control_1

Intravenous administration of magnesium sulfate 5mL(2.5mmol) before propofol

Interventions/Control_2

Intravenous administration of saline 5mL before propofol

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

18 years-old <=

Age-upper limit

60 years-old >

Gender

Male and Female

Key inclusion criteria

Patients (American Society of Anesthesiologists physical status I-II) scheduled for elective surgery under general anesthesia without a combination of nerve block.

Key exclusion criteria

1)Daily intake Ca blocker
2)Daily intake antipsychotics
3)Having heart, liver or kidney comprication
4)BMI over 35
5)Having arrhythmia, or AV block
6)Preoperative blood magnesium concentration over 2.6mg/dL
7)Not obtained informed consent

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukitoshi Niiyama

Organization

Sapporo Medical University, School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan

TEL

011-611-2111(ext.3568)

Email

niiyama@sapmed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nobuyoshi Matsuoka

Organization

Sapporo Medical University, School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan

TEL

011-611-2111(ext.3568)

Homepage URL


Email

nobu_xt7@hotmail.com


Sponsor or person

Institute

Sapporo Medical University, School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


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

札幌医科大学付属病院(北海道)


Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 30 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

Terminated

Date of protocol fixation

2013 Year 09 Month 06 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 30 Day

Last follow-up date

2014 Year 04 Month 01 Day

Date of closure to data entry

2014 Year 04 Month 01 Day

Date trial data considered complete

2014 Year 04 Month 01 Day

Date analysis concluded

2014 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2013 Year 09 Month 25 Day

Last modified on

2015 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013873


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name