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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024495
Receipt No. R000028185
Scientific Title Comparison of the effect of continuous intravenous infusion and two bolus injections of remifentanil on haemodynamic responses during anaesthesia induction: a prospective open-label randomised trial
Date of disclosure of the study information 2016/10/20
Last modified on 2016/10/19

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Basic information
Public title Comparison of the effect of continuous intravenous infusion and two bolus injections of remifentanil on haemodynamic responses during anaesthesia induction: a prospective open-label randomised trial
Acronym Comparison of the effect of continuous intravenous infusion and bolus injections of remifentanil on haemodynamic responses during anaesthesia induction
Scientific Title Comparison of the effect of continuous intravenous infusion and two bolus injections of remifentanil on haemodynamic responses during anaesthesia induction: a prospective open-label randomised trial
Scientific Title:Acronym Comparison of the effect of continuous intravenous infusion and bolus injections of remifentanil on haemodynamic responses during anaesthesia induction
Region
Japan

Condition
Condition Induction of anaesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Remifentanil is a rapid-onset and ultra-short acting opioid. Since laryngoscopy and tracheal intubation can result in tachycardia and hypertension, remifentanil is commonly used not only to maintain anaesthesia, but also to attenuate adverse haemodynamic changes due to tracheal intubation. To raise the effect-site concentration of remifentanil quickly, it is infused at higher concentrations or injected in bolus doses prior to constant continuous infusion. However, differences in haemodynamics during anaesthesia induction between continuous infusion and bolus injection of remifentanil have not yet been investigated. In addition, it remains unclear which method is best suited to hypertensive patients in whom tachycardia and hypertension by intubation may be exaggerated.
The aims of this randomised open-label study were to compare the haemodynamic responses during anaesthesia induction between continuous intravenous infusion and bolus injections of remifentanil in normotensive patients, as well as in treated and untreated hypertensive patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes heart rate and non-invasive blood pressure immediately before tracheal intubation
Key secondary outcomes 1) heart rate and blood pressure immediately after tracheal intubation
2) heart rate and blood pressure during anaesthesia induction
3) adverse events (HR or SBP decreased to less than 50 bpm or 70 mmHg)
4) use of ephedrine: If HR or SBP decreased to less than 50 bpm or 70 mmHg respectively, IV of 4 mg ephedrine was deemed necessary

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 remifentanil administration type: the continuous intravenous (IV) infusion group (Group C)
Interventions/Control_2 remifentanil administration type: the IV bolus group (Group B)
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
90 years-old >
Gender Male and Female
Key inclusion criteria American Society of Anesthesiologists physical status (ASA) I-II patients scheduled for elective surgery under general anaesthesia were prospectively enrolled.
Key exclusion criteria Exclusion criteria included patients younger than 20 years of age and with the presence of cardiovascular or cerebrovascular disease, renal failure, or a predicted difficult airway. If tracheal intubation was not performed within 1 minute, this patient was excluded.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toyoaki Maruta
Organization Miyazaki Medical College, University of Miyazaki
Division name Departments of Anesthesiology
Zip code
Address Miyazaki 889-1692, Japan
TEL 0985-85-1742
Email mmctm2@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toyoaki Maruta
Organization Miyazaki Medical College, University of Miyazaki
Division name Departments of Anesthesiology
Zip code
Address Miyazaki 889-1692, Japan
TEL 0985-85-1742
Homepage URL
Email mmctm2@yahoo.co.jp

Sponsor
Institute University of Miyazaki
Institute
Department

Funding Source
Organization University of Miyazaki
Organization
Division
Category of Funding Organization Government offices of other countries
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
2016 Year 10 Month 20 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
A total of 107 patients were recruited from October 2013 to June 2015.There were 82 normotensive patients older than 20 years of age (n = 41 in both groups), 14 treated HT patients (n = 7 in both groups) and 11 untreated HT patients (n = 7 in Group C and n = 4 in Group B). Both the treated and untreated HT subgroups were compared between Group C and Group B. In both normotensive and treated HT patients, there were no significant differences between Group C and Group B in age, gender, height, weight, BMI, and ASA.
Comparisons of HR, SBP, diastolic blood pressure (DBP), and mean blood pressure (MBP) in normotensive patients between Group C and Group B: There were no significant differences between the groups for any parameters at any time points. When compared to baseline, HR was not significantly different at any time points in either group. 
Comparisons of HR, SBP, DBP, and MBP within treated and untreated HT patients between Group C and Group B: There were no significant differences between groups for any parameters at any time points in each subgroup.
Use of additional propofol and adverse events including HR < 50 bpm, SBP < 70 mmHg, and use of ephedrine: There were no significant differences between groups in each subgroup.
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
2013 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 18 Day
Last follow-up date
2015 Year 06 Month 18 Day
Date of closure to data entry
2015 Year 06 Month 18 Day
Date trial data considered complete
2016 Year 05 Month 18 Day
Date analysis concluded
2016 Year 05 Month 18 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 19 Day
Last modified on
2016 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028185

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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