UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025364
Receipt number R000028900
Scientific Title Clinical study of shivering after general anesthesia (anesthesia method and body temperature)
Date of disclosure of the study information 2017/01/10
Last modified on 2020/05/12 15:58:03

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Basic information

Public title

Clinical study of shivering after general anesthesia (anesthesia method and body temperature)

Acronym

Clinical study of shivering after general anesthesia

Scientific Title

Clinical study of shivering after general anesthesia (anesthesia method and body temperature)

Scientific Title:Acronym

Clinical study of shivering after general anesthesia

Region

Japan


Condition

Condition

jaw deformity

Classification by specialty

Oral surgery Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We study that anesthesia method and the change of body temperature relate to frequency of shivering.

Basic objectives2

Others

Basic objectives -Others

We study prophylaxis of shivering

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We measure the frequency of shivering after general anesthesia.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

6

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

oxygen, laughing gas, sevoflurane, remifentanil

Interventions/Control_2

oxygen, laughing gas, sevoflurane, remifentanil, fentanil

Interventions/Control_3

oxygen, laughing gas, sevoflurane, fentanil

Interventions/Control_4

oxygen, laughing gas, propofol, remifentanil

Interventions/Control_5

oxygen, laughing gas, propofol, remifentanil, fentanil

Interventions/Control_6

oxygen, laughing gas, propofol, fentanil

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 with jaw deformity operated lower jawbone osteotomy

Key exclusion criteria

patients with jaw deformity operated lower and upper jawbone osteotomy

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Hajime
Middle name
Last name Ishibashi

Organization

Nihon University School of Dentistry at Matsudo

Division name

Department of Anesthesiology

Zip code

271-8587

Address

2-870-1, Sakaecho-Nishi, Matsudo, Chiba

TEL

047-360-9440

Email

ishibashi.hajime@nihon-u.ac.jp


Public contact

Name of contact person

1st name Hajime
Middle name
Last name Ishibashi

Organization

Nihon University School of Dentistry at Matsudo

Division name

Department of Anesthesiology

Zip code

271-8587

Address

2-870-1, Sakaecho-Nishi, Matsudo, Chiba

TEL

047-360-9440

Homepage URL


Email

ishibashi.hajime@nihon-u.ac.jp


Sponsor or person

Institute

Nihon University

Institute

Department

Personal name



Funding Source

Organization

Nihon University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nihon University School of Dentistry at Matsudo

Address

2-870-1, Sakaecho-Nishi, Matsudo, Chiba

Tel

047-360-9440

Email

ishibashi.hajime@nihon-u.ac.jp


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

日本大学松戸歯学部付属病院(千葉県)


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 10 Day


Related information

URL releasing protocol

http://mol.medicalonline.jp/library/openurl/query?rft.issn=0385-0145&rft.volume=43&rft.issue=3&rft.s

Publication of results

Published


Result

URL related to results and publications

http://mol.medicalonline.jp/library/openurl/query?rft.issn=0385-0145&rft.volume=43&rft.issue=3&rft.s

Number of participants that the trial has enrolled

91

Results

Significant differences in body temperature changes were found between the NS and S group (p = 0.004). The mean skin temperature in the S group was higher than in the NS group. Mean skin temperature was significantly higher in the sevoflurane group than in the propofol group (p < 0.000).

Results date posted

2020 Year 05 Month 12 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2017 Year 12 Month 01 Day

Baseline Characteristics

Mean of age and gender ratio (male/female) in each groups were followed: GOS-F group(28.5, 6/11), GOS-R group (25.8, 8/9), GOS-RF group (24.7, 8/6), GOP-F(25.0, 6/6), GOP-R group (26.0, 3/10) and GOP-RF group (25.8, 8/10).

Participant flow

Total patient numbers were 91. Number of GOS-F group, GOS-R group, GOS-RF group, GOP-F group , GOP-R group, and GOP-RF group were 17, 17, 14, 12, 13 and 18.

Adverse events

no

Outcome measures

Based on the occurrence of shivering, the 91 patients were classified into a shivering (S) group (n = 22, 24.2 %) and a non-shivering (NS) group (n = 69, 75.8 %). The RF anesthesia subgroups had 19 patients in the S group and 43 in the NS group; The non-RF anesthesia subgroups had 3 patients in the S group and 26 in the NS group. Thus, shivering was significantly associated with RF anesthesia (p = 0.035).
Significant differences in body temperature changes (change from control value) were found between the NS and S group (p = 0.004). The mean skin temperature in the S group was higher than in the NS group. Mean skin temperature was significantly higher in the sevoflurane group than in the propofol group (p < 0.000).
Significant differences were found between the NS and S groups in forearm minus-fingertip skin temperature gradients (p = 0.008). Forearm minus-fingertip skin temperature gradients differed significantly between the sevoflurane and propofol- groups (p = 0.031).
No significant changes in bladder temperature were observed between the NS and S groups (p = 0.239) or between the sevoflurane and propofol groups (p = 0.379).

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 12 Month 20 Day

Date of IRB

2016 Year 10 Month 16 Day

Anticipated trial start date

2017 Year 02 Month 01 Day

Last follow-up date

2019 Year 03 Month 15 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 12 Month 22 Day

Last modified on

2020 Year 05 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028900