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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028193
Receipt No. R000032221
Scientific Title The research to take the oral tablet morphine sulphate for preoperative under general anesthesia: to postoprative pain and sedation
Date of disclosure of the study information 2017/07/12
Last modified on 2017/07/12

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Basic information
Public title The research to take the oral tablet morphine sulphate for preoperative under general anesthesia: to postoprative pain and sedation
Acronym The research to take the oral tablet morphine sulphate for preoperative under general anesthesia: to postoprative pain and sedation
Scientific Title The research to take the oral tablet morphine sulphate for preoperative under general anesthesia: to postoprative pain and sedation
Scientific Title:Acronym The research to take the oral tablet morphine sulphate for preoperative under general anesthesia: to postoprative pain and sedation
Region
Japan

Condition
Condition We intend for ASA PS 1-2 from 20-80years old having anoperation of limbs among orthopedics patients
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Before surgery, oral tablet morphine sulphate 60mg preparation (surveyed group) or diazepam 5-7mg (comparative control group) is taken orally, and the difference between postoperative pain and sedation between the two groups and side effects are compared.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postoperative pain and side effects for oral tablet morphine sulfate are mainly determined around 4-6,18-24 hours after oral.
For postoperative pain relief, use of analgesic drugs as a main index.And we also visited patients up to 3 days postoperatively, including confirmation of side effects.
Key secondary outcomes Key secondary outcomes for postoperativepain,and sedation :Postoperativepain are determined VAS scale, and diverted part of face scale. For sedation, use the Ramsay sedation score (RSS). In addition, measure the blood concentration at the perioperative period from some patients, and use it as a reference index of the drug effect.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
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
Medicine
Interventions/Control_1 Study group: 60 mg of sustained-release morphine sulfate administered orally at 90 to 120 minutes before introduction of general anesthesia. Then I went to the operating room.

General anesthesia is 1% propofol (1 mg / kg) with introduction drug, sevoflurane, nitrous oxide, oxygen (oxygen concentration in the circuit 50%) for maintenance. The concentration of sevoflurane in the intraoperative carburetor will be set appropriately according to the situation of anesthesia and surgery. After that, we perform fundamental perioperative management and at the same time conduct surveys to be described later.
investigation:
Analgesia: Study using visual analog scale (VAS) score face scale (part diverted) immediately after returning home (4-6 hours after oral administration) and blood collection after returning (12-18 hours after oral administration) .In addition, 50 mg intravenous flurbiprofen (Flurbiprofen) as an analgesic, intramuscular injection of 30 mg pentazocine + 50 mg hydroxyzine (Hydroxyzine), 50 mg dose of diclofenac sodium (Diclofenac) according to the degree of analgesia. The use standard was VAS 50 mm or more. Also investigate the use of analgesics.
Sedation: Investigate using Ramsay sedation score (RSS) after oral administration, 2 hours, 4-6 hours, 12-18 hours.
and Investigation of circulatory dynamics during operation: (blood pressure, heart rate) etc.
And Morphine blood concentration is collected (at least twice) in 2, 4-6 and 12-18 hours after premedication.
The intervention period was up to 24 hours after drug oral.
In addition, when side effects appear, appropriate drug administration and treatment corresponding to symptoms should be carried out.
Interventions/Control_2 Comparative control group: 5-7 mg of diazepam orally administered 90 to 120 minutes before introduction of general anesthesia. Then I went to the operating room.
In the control group. No blood was drawn. Other general anesthesia management, postoperative analgesia, evaluation of sedation, and analgesic treatment were performed in the same manner as in the survey group.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients with good overall condition of 1-2 at ASA ps and cooperative patients for this survey were targeted.
Also, in the survey group, those who got an understanding of this research before the surgery and gave the consent form were targeted.
Key exclusion criteria We excluded those less than ASA physical status and non-cooperative in research.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Ozaki
Organization Tokyo women's medical university medical hospital
Division name Anestheology
Zip code
Address 8-1 Kawadamachi, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Email doku_kumo@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takaaki Chino
Organization Tokyo Women's medical University Medical Hospital
Division name Anestheology
Zip code
Address 8-1 Kawadamachi, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Homepage URL
Email ikyoku@anes.twmu.ac.jp

Sponsor
Institute Tokyo women's medical university medical hospital
Institute
Department

Funding Source
Organization Tokyo women's medical university medical 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 谷津保健病院(千葉県)、総合守谷第一病院(茨城県)

Other administrative information
Date of disclosure of the study information
2017 Year 07 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
2006 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2006 Year 11 Month 24 Day
Last follow-up date
2013 Year 06 Month 03 Day
Date of closure to data entry
2017 Year 06 Month 25 Day
Date trial data considered complete
2017 Year 07 Month 05 Day
Date analysis concluded
2017 Year 07 Month 10 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 12 Day
Last modified on
2017 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032221

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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