Trial Outcomes & Findings for Neuromuscular Blocking Agents in the Elderly (NCT NCT03857750)
NCT ID: NCT03857750
Last Updated: 2020-06-02
Results Overview
The time from the end of rocuronium injection to train-of-four (TOF) count of 0 monitored by acceleromyography. The ulnar nerve was stimulated during the monitoring.
COMPLETED
32 participants
Day 0, after induction of anesthesia
2020-06-02
Participant Flow
Patients were included from the Departments of Anaesthesia, Centre of Head and Orthopaedics and Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Denmark in the period of the 27th of March 2019 to 7th of November 2019.
Five of 37 patients were excluded due to rescheduling, rapid sequence induction, prone position and different anesthetic medication. 3 patients in each group have missing data on duration of action due to supplementary doses of rocuronium.
Participant milestones
| Measure |
Elderly (>80 Years)
16 patients planned for elective surgery above 80 years
Rocuronium: 0.6 mg/kg
|
Younger (18-40 Years)
16 patients planned for elective surgery between 18-40 years
Rocuronium: 0.6 mg/kg
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Elderly (>80 Years)
n=16 Participants
16 patients planned for elective surgery above 80 years
Rocuronium: 0.6 mg/kg
|
Younger (18-40 Years)
n=16 Participants
16 patients planned for elective surgery between 18-40 years
Rocuronium: 0.6 mg/kg
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
84 years
n=16 Participants
|
31 years
n=16 Participants
|
60 years
n=32 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=16 Participants
|
13 Participants
n=16 Participants
|
26 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=16 Participants
|
3 Participants
n=16 Participants
|
6 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Denmark
|
16 participants
n=16 Participants
|
16 participants
n=16 Participants
|
32 participants
n=32 Participants
|
|
Height
|
164 centimeters
n=16 Participants
|
174 centimeters
n=16 Participants
|
169 centimeters
n=32 Participants
|
|
Weight
|
74 kilograms
n=16 Participants
|
72.5 kilograms
n=16 Participants
|
73.5 kilograms
n=32 Participants
|
|
ASA
ASA I
|
1 Participants
n=16 Participants
|
6 Participants
n=16 Participants
|
7 Participants
n=32 Participants
|
|
ASA
ASA II
|
8 Participants
n=16 Participants
|
9 Participants
n=16 Participants
|
17 Participants
n=32 Participants
|
|
ASA
ASA III
|
7 Participants
n=16 Participants
|
1 Participants
n=16 Participants
|
8 Participants
n=32 Participants
|
|
Comorbidities
Heart disease
|
7 participants
n=16 Participants
|
1 participants
n=16 Participants
|
8 participants
n=32 Participants
|
|
Comorbidities
Hypertension
|
13 participants
n=16 Participants
|
0 participants
n=16 Participants
|
13 participants
n=32 Participants
|
|
Comorbidities
Liver disease
|
0 participants
n=16 Participants
|
1 participants
n=16 Participants
|
1 participants
n=32 Participants
|
|
Comorbidities
Renal disease
|
2 participants
n=16 Participants
|
0 participants
n=16 Participants
|
2 participants
n=32 Participants
|
|
Comorbidities
Diabetes
|
3 participants
n=16 Participants
|
0 participants
n=16 Participants
|
3 participants
n=32 Participants
|
|
Medication
Any
|
15 participants
n=16 Participants
|
11 participants
n=16 Participants
|
26 participants
n=32 Participants
|
|
Medication
Loop-diuretics or thiazids
|
8 participants
n=16 Participants
|
5 participants
n=16 Participants
|
13 participants
n=32 Participants
|
|
Medication
Magnesium
|
1 participants
n=16 Participants
|
0 participants
n=16 Participants
|
1 participants
n=32 Participants
|
|
Duration of anesthesia
|
164 minutes
n=16 Participants
|
146 minutes
n=16 Participants
|
154 minutes
n=32 Participants
|
|
Duration of surgery
|
104 minutes
n=16 Participants
|
101 minutes
n=16 Participants
|
102 minutes
n=32 Participants
|
PRIMARY outcome
Timeframe: Day 0, after induction of anesthesiaThe time from the end of rocuronium injection to train-of-four (TOF) count of 0 monitored by acceleromyography. The ulnar nerve was stimulated during the monitoring.
Outcome measures
| Measure |
Elderly (>80 Years)
n=16 Participants
16 patients planned for elective surgery above 80 years
Rocuronium: 0.6 mg/kg
|
Younger (18-40 Years)
n=16 Participants
16 patients planned for elective surgery between 18-40 years
Rocuronium: 0.6 mg/kg
|
|---|---|---|
|
Onset Time
|
135 seconds
Interval 135.0 to 158.0
|
90 seconds
Interval 60.0 to 105.0
|
SECONDARY outcome
Timeframe: Day 0, after induction of anesthesia90 seconds after induction the conditions are rated by the Intubating Difficulty Scale (IDS). Easy is defined as IDS of 0. Slight is defined as IDS of 1 to 5 Moderate/Major is defined as \>5
Outcome measures
| Measure |
Elderly (>80 Years)
n=16 Participants
16 patients planned for elective surgery above 80 years
Rocuronium: 0.6 mg/kg
|
Younger (18-40 Years)
n=16 Participants
16 patients planned for elective surgery between 18-40 years
Rocuronium: 0.6 mg/kg
|
|---|---|---|
|
Comparing Intubating Conditions in the Two Groups
Easy
|
7 Participants
|
7 Participants
|
|
Comparing Intubating Conditions in the Two Groups
Slight
|
8 Participants
|
9 Participants
|
|
Comparing Intubating Conditions in the Two Groups
Moderate/Major
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0, after induction of anesthesiaPopulation: 3 in each group had missing data due to supplementary doses of rocuronium
Time from end of rocuronium injection to TOF ratio \>0.9. When the ratio between the first and last stimulation in TOF is above 90 %.
Outcome measures
| Measure |
Elderly (>80 Years)
n=13 Participants
16 patients planned for elective surgery above 80 years
Rocuronium: 0.6 mg/kg
|
Younger (18-40 Years)
n=13 Participants
16 patients planned for elective surgery between 18-40 years
Rocuronium: 0.6 mg/kg
|
|---|---|---|
|
Duration of Action
|
81 minutes
Interval 71.0 to 97.0
|
53 minutes
Interval 42.0 to 73.0
|
Adverse Events
Elderly (>80 Years)
Younger (18-40 Years)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place