UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024495 |
|---|---|
| Receipt number | 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 23:55:20 |
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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
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
mmctm2@yahoo.co.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028185
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