UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The research to take the oral tablet morphine sulphate for preoperative under general anesthesia: to postoprative pain and sedation
Title of the study (Brief title)	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	Makoto Ozaki
Organization	Tokyo women's medical university medical hospital
Division name	Anestheology
Address	8-1 Kawadamachi, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Email	doku_kumo@yahoo.co.jp

Public contact
Name of contact person	Takaaki Chino
Organization	Tokyo Women's medical University Medical Hospital
Division name	Anestheology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 08 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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