UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030217 |
|---|---|
| Receipt number | R000034516 |
| Scientific Title | Prospective randomized comparison of effect of dexmedetomidine and remifentanil on intubation, intraoperative hemodynamics and revocery during general anesthesia for laryngeal microsurgery |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2021/03/05 22:51:24 |
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Basic information
Public title
Prospective randomized comparison of effect of dexmedetomidine and remifentanil on intubation, intraoperative hemodynamics and revocery during general anesthesia for laryngeal microsurgery
Acronym
Prospective randomized comparison of effect of dexmedetomidine and remifentanil during general anesthesia for laryngeal microsurgery
Scientific Title
Prospective randomized comparison of effect of dexmedetomidine and remifentanil on intubation, intraoperative hemodynamics and revocery during general anesthesia for laryngeal microsurgery
Scientific Title:Acronym
Prospective randomized comparison of effect of dexmedetomidine and remifentanil during general anesthesia for laryngeal microsurgery
Region
| Asia(except Japan) |
Condition
Condition
Prospective randomized trial
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Layngeal microsurgery involves intense laryngeal stimulation and hemodynamic response. Adverse intubation condition as well as strong emergence response is not desirable, because it may associated with post operative laryngeal morbidity. Dexmedetomidine has sympatholytic and antinociceptive property, so it can be used for subsitute for opioids during general anesthesia. Remifentanil is well known for rapidly acting mu opioid agonist, and widely used during general anesthesia. The aim of this study is to compare effect of dexmedetomidine and remifentanil on intubation, intraoperative hemodynamics and recovery characteristics during desflurane anesthesia for laryngeal microsurgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
intubation score, and intra-operative hemodynamic stability
Key secondary outcomes
desflurane requirement, emergence time, cough response score, agitation score, sore throat VAS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dexmedetomidine diluted with saline 1.0 mcg/kg for 10 minutes loading infusion and saline 5 cc 1 minute bolus before induction of propofol 2 mg/kg and rocuronium 0.5 mg/kg, and then maintenance dose 0.5-1.0 mcg/kg/hr of study drug
Interventions/Control_2
Saline (placebo) for 10 minutes and Remifentanil 1.0 mcg/kg diluted with saline 5cc bolus for 1 minutes before induction of propofol 2 mg/kg and rocuronium 0.5 mg/kg, and then maintenance dose 0.05-0.1 mcg/kg/min
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA 1,2 presenting for laryngeal microsurgery
Key exclusion criteria
Refusal to give consent, Hemodynamic instability, Cardiovascular disease, Myocardial infarct, hear frailure, asthma, recent upper respiratory infection, chronic kidney disease, severe liver disease, mental retardation, pregnancy, lactation , antihypertensive medication with angiotensin converting enzyme inhibitor
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Young Ju |
| Middle name | |
| Last name | Won |
Organization
Korea University Guro Hospital
Division name
Anesthesiology and Pain Medicine
Zip code
08308
Address
148 Gurodong-ro, Guro-gu, Seoul 08308
TEL
82226261437
moma2@naver.com
Public contact
Name of contact person
| 1st name | Hae Wone |
| Middle name | |
| Last name | Chang |
Organization
Korea University Guro Hospital
Division name
Anesthesiology and Pain Medicine
Zip code
08308
Address
148 Gurodong-ro, Guro-gu, Seoul 08308
TEL
82226261437
Homepage URL
chelenh@gmail.com
Sponsor or person
Institute
Korea University Guro Hospital
Institute
Department
Personal name
Funding Source
Organization
Korea University Guro 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
Korea University Guro Hospital
Address
148, Gurodong-ro, Guro-gu, Seoul, Korea
Tel
82-2-2626-1632
eirbadmin@kumc.or.kr
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
Korea University Guro Hospital
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 01 | 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
| 2017 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 18 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 18 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 18 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 01 | Day |
Last modified on
| 2021 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034516
