UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006269
Receipt number R000007420
Scientific Title Efficacy of capsicam plaster at acupoint GV14 in preventing postanesthetic shivering
Date of disclosure of the study information 2011/09/01
Last modified on 2013/03/01 10:23:47

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Basic information

Public title

Efficacy of capsicam plaster at acupoint GV14 in preventing postanesthetic shivering

Acronym

Acustimulation with capsicum plaster in prevention of postanesthetic shivering

Scientific Title

Efficacy of capsicam plaster at acupoint GV14 in preventing postanesthetic shivering

Scientific Title:Acronym

Acustimulation with capsicum plaster in prevention of postanesthetic shivering

Region

Asia(except Japan)


Condition

Condition

adult patients undergoing general anesthesia for elective minor urological surgery were recruited into the study

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of GV14 acupoint stimulation on the incidence of postanesthetic shivering

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

the overall incidence and grades of postanesthetic shivering

Key secondary outcomes



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

3

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

In group A, the capsicum plaster was affixed at the GV14 acupoint.

Interventions/Control_2

In group B, a similar inactive adhesive plaster on the same point.

Interventions/Control_3

In group C, the capsicum plaster was affixed at the 5 cm of the left of GV14 acupoint. All adhesive plaster were performed for a period of 30 min before the induction of anesthesia and were maintained until the patient return to the ward.

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

adult patients (ASA physical status I or II) scheduled for elective minor urological surgery under general anesthetic with no prior medication were included in this study

Key exclusion criteria

1, initial body temperature more than 38 centigrade or less than 36.5 centigrade;
2, hyperthyroidism, hypertension, diabetes mellitus, impaired renal or liver functions, endocrine or cardiopulmonary disease;
3, taking vasoactive or antidepressant drugs, receiving intraoperative blood or blood products transfusion;
4, known history of alcohol or substance abuse, or possible pregnancy;

Target sample size

240


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Chen Jie

Organization

Third Military Medical University

Division name

Department of Anaesthesiology, Southwest Hospital,

Zip code


Address

Gaotanyan road, Shapingba, Chongqing, China

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Third Military Medical University

Division name

Department of Anaesthesiology, Southwest Hospital,

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Anaesthesiology, Southwest Hospital,

Institute

Department

Personal name



Funding Source

Organization

Department of Anaesthesiology, Southwest Hospital,

Organization

Division

Category of Funding Organization

Self funding

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

2011 Year 09 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

2011 Year 08 Month 09 Day

Date of IRB


Anticipated trial start date

2011 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 09 Month 01 Day

Last modified on

2013 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007420


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name