UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024629 |
|---|---|
| Receipt number | R000028334 |
| Scientific Title | The effect of intravenous Ketamine for postoperative pain after laparoscopic cholecystectomy |
| Date of disclosure of the study information | 2016/10/31 |
| Last modified on | 2020/05/12 16:10:22 |
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Basic information
Public title
The effect of intravenous Ketamine for postoperative pain after laparoscopic cholecystectomy
Acronym
The effect of Ketamine for postoperative pain
Scientific Title
The effect of intravenous Ketamine for postoperative pain after laparoscopic cholecystectomy
Scientific Title:Acronym
The effect of Ketamine for postoperative pain
Region
| Japan |
Condition
Condition
Patients undergoing laparoscopic cholecystectomy
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the effect of intravenous administration of Ketamine for postoperative pain in patients undergoing laparoscopic cholecystectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluating the postoperative pain by using Visual Analogue Scale (VAS).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control group
Manage the general anesthesia by TIVA(Total intravenous anesthesia),using propofol,remifentanil,fentanyl. Control the effect cite fentanyl concentration within 1-1.5 ng/ml at the end of the anesthesia.
Interventions/Control_2
Ketamine group
Manage the general anesthesia as the control group. In this intervention group, also administer Ketamine 0.5 mg/kg intravenously before incision.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Man and female with the age between 20 to 75 years old.
2) Patients undergoing laparoscopic cholecystectomy
Key exclusion criteria
1) Patients having cerebrovascular disease, hypertention(systolic blood pressure over 160mmHg, diastolic blood pressure over 100mmHg), elevated intracranial pressure, severe heart failure.
2) Past medical histroy of convulsion.
3) Pregnant woman and woman having the possibility of pregnancy.
4) Obese patients with BMI over 35.
5) Patients excluded by the judge of principal investigator.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko Mae |
Organization
Tokyo Metropolitan Police Hospital
Division name
Department of Anesthesiology
Zip code
Address
4-22-1 Nakano, Nakano-ku,Tokyo,Japan
TEL
03-5343-5611
chikomae@sa2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Mae |
Organization
Tokyo Metropolitan Police Hospital
Division name
Department of Anesthesiology
Zip code
Address
4-22-1 Nakano, Nakano-ku,Tokyo,Japan
TEL
03-5343-5611
Homepage URL
chikomae@sa2.so-net.ne.jp
Sponsor or person
Institute
Tokyo Metropolitan Police 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
| 2016 | Year | 10 | Month | 31 | 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
27
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
| 2016 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 29 | Day |
Last modified on
| 2020 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028334
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
