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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030217
Receipt No. 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 2017/12/04

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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
Middle name
Last name Won Young Ju
Organization Korea University Guro Hospital
Division name Anesthesiology and Pain Medicine
Zip code
Address 148 Gurodong-ro, Guro-gu, Seoul 08308
TEL 82226261437
Email moma2@naver.com

Public contact
Name of contact person
1st name
Middle name
Last name Hae Wone Chang
Organization Korea University Guro Hospital
Division name Anesthesiology and Pain Medicine
Zip code
Address 148 Gurodong-ro, Guro-gu, Seoul 08308
TEL 82226261437
Homepage URL
Email chelenh@gmail.com

Sponsor
Institute Korea University Guro Hospital
Institute
Department

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
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 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 Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 02 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
2017 Year 12 Month 01 Day
Last modified on
2017 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034516

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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