UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028193 |
|---|---|
| Receipt number | 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 00:00:03 |
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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
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
ikyoku@anes.twmu.ac.jp
Sponsor or person
Institute
Tokyo women's medical university medical hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032221
