UMIN-CTR Clinical Trial

Basic information
Public title	Effects of pre-warming during epidural combined general anesthesia on body temperature reduction by induction of anesthesia
Acronym	Effects of pre-warming on body temperature reduction by induction of anesthesia
Scientific Title	Effects of pre-warming during epidural combined general anesthesia on body temperature reduction by induction of anesthesia
Scientific Title:Acronym	Effects of pre-warming on body temperature reduction by induction of anesthesia
Region	Japan

Condition
Condition	Patients undergoing laparoscopic surgery in the supine position under general anesthesia combined with an epidural
Classification by specialty	Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether the timing of initiation of a forced air warming device can prevent a decrease in central temperature in patients undergoing surgery under general anesthesia combined with epidural.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The degree of temperature and body temperature change between the two groups from the time of admission to the end of surgery will be compared.
Key secondary outcomes	Comparison of the presence or absence of shivering and surgical site infection (e.g., redness and wound separation) between the two groups

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Forced air warming equipment started immediately after entering the operating room.
Interventions/Control_2	Forced air warming equipment started just before starting surgery.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. patients in waiting laparoscopic surgery 2. general anesthesia combined with epidural 3. over 20 years old 4. the surgical position is supine 5. patients who have given written consent
Key exclusion criteria	1. inadequate data (e.g., medical records) 2. patients who are deemed unsuitable to participate in the study due to other serious complications
Target sample size	120

Research contact person
Name of lead principal investigator	1st name kazuhiro Middle name Last name shirozu
Organization	Kyushu University Hospital
Division name	Anesthesia and critical care medicine
Zip code	814-0001
Address	3-1-1 maidashi, higashi-ku, Fukuoka
TEL	092-642-5714
Email	shirozu.kazuhiro.334@m.kyushu-u.ac.jp

Public contact
Name of contact person	1st name kazuhiro Middle name Last name shirozu
Organization	Kyushu University Hospital
Division name	Anesthesia and critical care medicine
Zip code	814-0001
Address	3-1-1 maidashi, higashi-ku, Fukuoka
TEL	092-642-5714
Homepage URL
Email	shirozu.kazuhiro.334@m.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University Hospital
Institute
Department

Funding Source
Organization	Kyushu University Hospital
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	Center for Clinical and Translational Research(CCTR)
Address	3-1-1 maidashi, higashi-ku, Fukuoka
Tel	092-642-5082
Email	byskenkyu@jimu.kyushu-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

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 15 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	120
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	2020 Year 03 Month 30 Day
Date of IRB	2020 Year 04 Month 14 Day
Anticipated trial start date	2020 Year 04 Month 15 Day
Last follow-up date	2023 Year 04 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	2020 Year 04 Month 06 Day
Last modified on	2022 Year 07 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045674