UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025386
Receipt No. R000029227
Scientific Title Dexamethazone versus ketamine in interscalene block in patients undergoing arthroscopic shoulder surgery. A randomized double-blinded study.
Date of disclosure of the study information 2017/01/15
Last modified on 2018/12/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Dexamethazone versus ketamine in interscalene block in patients undergoing arthroscopic shoulder surgery. A randomized double-blinded study.

Acronym Dexamethazone versus ketamine in interscalene block in arthroscopic shoulder surgery.
Scientific Title Dexamethazone versus ketamine in interscalene block in patients undergoing arthroscopic shoulder surgery. A randomized double-blinded study.

Scientific Title:Acronym Dexamethazone versus ketamine in interscalene block in arthroscopic shoulder surgery.
Region
Africa

Condition
Condition The recruiting cases is going on
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 compare first request of analgesia between dexamethazone and ketamine in interscalene block in patients undergoing arthroscopic shoulder surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes compare first request of analgesia between dexamethazone and ketamine in interscalene block in patients undergoing arthroscopic shoulder surgery.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 First group receive interscalene block with bupivacaine 0.25%plus 8mg dexamethazone (Group D),
Interventions/Control_2 other group receive interscalene block with bupivacaine 0.25% plus 50mg ketamine (Group K).
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
60 years-old >=
Gender Male and Female
Key inclusion criteria ASA I &II
arthroscopic shoulder surgery
Key exclusion criteria Obstructive pulmonary disease
Diabetes
Neuropathy
Contralateral diaphragmatic paralysis
A history of allergic reaction to any of the study drugs
Epilepsy.
Neuromuscular disease.
Hematological disorders.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Khaled Elbahrawy
Organization Mansoura University
Division name Anesthesia
Zip code
Address Egypt,Mansoura
TEL 00201121011768
Email Elbahrawy_khaled@yahoo.com

Public contact
Name of contact person
1st name
Middle name
Last name Dr Khaled Elbahrawy
Organization Mansoura university hospital
Division name Anesthesia
Zip code
Address Egypt
TEL 0020502202515
Homepage URL
Email Elbahrawy_khaled@yahoo.com

Sponsor
Institute Mansoura university hospital

Anesthesia department
Institute
Department

Funding Source
Organization Self fund
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 15 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
2016 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 23 Day
Last modified on
2018 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029227

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.