Clinical Trial Results:
A single-blinded multicenter randomized study comparing intubating conditions after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in elderly patients.
Summary
|
|
EudraCT number |
2019-004121-25 |
Trial protocol |
DK |
Global end of trial date |
25 Jan 2021
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
27 Mar 2021
|
First version publication date |
27 Mar 2021
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
NMBA_ELDERLY2019ROCU_REMI
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT04287426 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Rigshospitalet
|
||
Sponsor organisation address |
Inge Lehmanns Vej 6, Copenhagen, Denmark, 2100
|
||
Public contact |
Department of Anaesthesia, Rigshospitalet, 45 35458043, lars.rasmussen.01@regionh.dk
|
||
Scientific contact |
Department of Anaesthesia, Rigshospitalet, 61652212 35458043, lars.rasmussen.01@regionh.dk
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
25 Feb 2021
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
25 Jan 2021
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
25 Jan 2021
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
The aim of this study is to determine the effect on intubating conditions
and laryngeal morbidity after either rocuronium 0.6 mg/kg or
remifentanil 2 µg/kg in patients with age ≥ 80 years.
|
||
Protection of trial subjects |
All patients received general anaesthesia and postoperative pain treatment
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Mar 2020
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Denmark: 78
|
||
Worldwide total number of subjects |
78
|
||
EEA total number of subjects |
78
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
55
|
||
85 years and over |
23
|
|
||||||||||||||||
Recruitment
|
||||||||||||||||
Recruitment details |
Recruitment took place between March 2020 and December 2020. | |||||||||||||||
Pre-assignment
|
||||||||||||||||
Screening details |
We screened patients above 80 years of age scheduled for elective spine surgery | |||||||||||||||
Period 1
|
||||||||||||||||
Period 1 title |
Overall (overall period)
|
|||||||||||||||
Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
|
|||||||||||||||
Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator, Data analyst, Assessor | |||||||||||||||
Blinding implementation details |
The intervention medicine was prepared outside the operating room and delivered to the clinical staff. The patients, investigators, and surgical staff were unaware of the allocation. Two authors did the data analysis without knowing the allocation as groups were named 0 or 1.
|
|||||||||||||||
Arms
|
||||||||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||||||||
Arm title
|
Rocuronium | |||||||||||||||
Arm description |
Rocuronium 0.6 mg/kg | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
rocuronium
|
|||||||||||||||
Investigational medicinal product code |
119302-91-9
|
|||||||||||||||
Other name |
||||||||||||||||
Pharmaceutical forms |
Solution for injection
|
|||||||||||||||
Routes of administration |
Intravenous bolus use
|
|||||||||||||||
Dosage and administration details |
0.6 mg/kg ideal body weight or actual body weight (the lowest) iv
|
|||||||||||||||
Arm title
|
Remifentanil | |||||||||||||||
Arm description |
Remifentanil 2 microgram pr kg | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Remifentanil
|
|||||||||||||||
Investigational medicinal product code |
132875-61-7
|
|||||||||||||||
Other name |
||||||||||||||||
Pharmaceutical forms |
Powder for suspension for injection
|
|||||||||||||||
Routes of administration |
Intravenous use
|
|||||||||||||||
Dosage and administration details |
Remifentanil 2 microgram pr kg ideal body weight or actual body weight (lowest) iv
|
|||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Rocuronium
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Rocuronium 0.6 mg/kg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Remifentanil
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Remifentanil 2 microgram pr kg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis sets
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set title |
Recruited
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
78 recruited
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Rocuronium
|
||
Reporting group description |
Rocuronium 0.6 mg/kg | ||
Reporting group title |
Remifentanil
|
||
Reporting group description |
Remifentanil 2 microgram pr kg | ||
Subject analysis set title |
Recruited
|
||
Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
78 recruited
|
|
|||||||||||||
End point title |
Excellent intubating conditions | ||||||||||||
End point description |
Fuchs-Buder scale
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Two minutes after drug adminstration
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Chi Square | ||||||||||||
Comparison groups |
Rocuronium v Remifentanil
|
||||||||||||
Number of subjects included in analysis |
74
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.29 | ||||||||||||
Method |
Chi-squared | ||||||||||||
Parameter type |
Risk difference (RD) | ||||||||||||
Point estimate |
0.11
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.09 | ||||||||||||
upper limit |
0.33 |
|
|||||||||||||
End point title |
Intervention against hypotension | ||||||||||||
End point description |
Use of ephedrine or phenylephrine as decided by blinded investigator
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From induction to patient ready for positioning
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Chi Square | ||||||||||||
Comparison groups |
Remifentanil v Rocuronium
|
||||||||||||
Number of subjects included in analysis |
74
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.51 | ||||||||||||
Method |
Chi-squared | ||||||||||||
Parameter type |
Risk difference (RD) | ||||||||||||
Point estimate |
0.07
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.13 | ||||||||||||
upper limit |
0.28 |
|
|||||||||||||
End point title |
Intubating difficulty score | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At intubation
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Mann Whitney's rank sum test | ||||||||||||
Comparison groups |
Rocuronium v Remifentanil
|
||||||||||||
Number of subjects included in analysis |
74
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.48 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Hoarseness | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At 24 hours after anaesthesia
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Chi square | ||||||||||||
Comparison groups |
Rocuronium v Remifentanil
|
||||||||||||
Number of subjects included in analysis |
74
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.86 | ||||||||||||
Method |
Chi-squared | ||||||||||||
Parameter type |
Risk difference (RD) | ||||||||||||
Point estimate |
0.02
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.24 | ||||||||||||
upper limit |
0.2 |
|
|||||||||||||
End point title |
Sore throat | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At 24 hours after anaesthesia
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Chi square | ||||||||||||
Comparison groups |
Remifentanil v Rocuronium
|
||||||||||||
Number of subjects included in analysis |
74
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.2 | ||||||||||||
Method |
Chi-squared | ||||||||||||
Parameter type |
Risk difference (RD) | ||||||||||||
Point estimate |
-0.09
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.22 | ||||||||||||
upper limit |
0.05 |
|
|||||||||||||||||||||||||||||||
Adverse events information [1]
|
|||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Three days after surgery
|
||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||
Dictionary version |
23
|
||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||
Reporting group title |
Remifentanil
|
||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||
Reporting group title |
Rocuronium
|
||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: We only considered drug-specific AE according to the product summary |
|||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||
|
|
|||||||
Substantial protocol amendments (globally) |
|||||||
Were there any global substantial amendments to the protocol? No | |||||||
Interruptions (globally) |
|||||||
Were there any global interruptions to the trial? Yes | |||||||
|
|||||||
Limitations and caveats |
|||||||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
None reported |