UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015675 |
|---|---|
| Receipt number | R000018188 |
| Scientific Title | Effects of preoperative protein liquid supplement on anesthesia-induced hypothermia: A prospective, randomized, double-blind study |
| Date of disclosure of the study information | 2014/11/12 |
| Last modified on | 2014/11/12 22:43:00 |
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Basic information
Public title
Effects of preoperative protein liquid supplement on anesthesia-induced hypothermia: A prospective, randomized, double-blind study
Acronym
Effects of preoperative protein liquid supplement on anesthesia-induced hypothermia: A prospective, randomized, double-blind study
Scientific Title
Effects of preoperative protein liquid supplement on anesthesia-induced hypothermia: A prospective, randomized, double-blind study
Scientific Title:Acronym
Effects of preoperative protein liquid supplement on anesthesia-induced hypothermia: A prospective, randomized, double-blind study
Region
| Japan |
Condition
Condition
myoma uteri
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we investigated the effects of preoperative oral intake of a high-protein liquid supplement on general anesthesia-induced hypothermia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The number of patients with core temperature less than 36.5 degree during surgery.
Key secondary outcomes
The number of patients with core temperature less than 36.5 degree immediately after induction of general anesthesia and postoperative shivering.
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Seventy patients drank 400 mL of a protein liquid supplement. The supplements were administered 3 h before entering the operation room.
Interventions/Control_2
Seventy patients drank the same volume of a protein-free oral rehydration solution containing as many calories as the high-protein supplement (adjusted using malto-oligosaccharide). The supplement was administered 3 h before entering the operation room.
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
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
We enrolled 140 patients who were hospitalized for abdominal total hysterectomy and myomectomy (categorized ASA physical status I-II). Only patients who were operated on early in the afternoon were selected.
Key exclusion criteria
Exclusion criteria were as follows: body mass index > 35 kg/m2, cardiac failure with NYHA classification more than II; respiratory failure with Hugh-Jones classification more than II; renal dysfunction; hepatic dysfunction; diabetes mellitus; thyroid disease; a history of gastrointestinal surgery; and acute infection.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miho Kaneko |
Organization
Tohoku University
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
Address
1-1 Seiryo-machi Aoba-ku, Sendai, Japan
TEL
022-717-7321
mihonakamura@lagoon.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mamoru Murakami |
Organization
Tohoku Kosai Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-3-11 Kokubunn-cho Aoba-ku, Sendai, Lapan
TEL
022-227-2211
Homepage URL
mamoru@ope-tohokukosai.com
Sponsor or person
Institute
Tohoku Kosai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2014 | Year | 11 | Month | 12 | 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 | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 12 | Day |
Last modified on
| 2014 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018188
