Trial Outcomes & Findings for Use of Neuromuscular Blocking Agents and Neuromuscular Monitoring in 7 Danish Teaching Hospitals (NCT NCT02914119)
NCT ID: NCT02914119
Last Updated: 2019-09-12
Results Overview
Recruitment status
COMPLETED
Target enrollment
30430 participants
Primary outcome timeframe
in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
Results posted on
2019-09-12
Participant Flow
Estimated number of included cases
Participant milestones
| Measure |
Eligible Patients
Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection.
Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received.
Rocuronium
Succinylcholine
Cisatracurium
Mivacurium
Objective neuromuscular monitoring (acceleromyography)
Sugammadex
Neostigmine
|
|---|---|
|
Overall Study
STARTED
|
30430
|
|
Overall Study
COMPLETED
|
30430
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Eligible Patients
n=30430 Participants
Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection.
Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received.
Rocuronium
Succinylcholine
Cisatracurium
Mivacurium
Objective neuromuscular monitoring (acceleromyography)
Sugammadex
Neostigmine
|
|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 20 • n=30430 Participants
|
|
Sex: Female, Male
Female
|
16920 Participants
n=30430 Participants
|
|
Sex: Female, Male
Male
|
13510 Participants
n=30430 Participants
|
PRIMARY outcome
Timeframe: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hoursPopulation: Patients receiving non-depolarizing neuromuscular blocking agent
Outcome measures
| Measure |
Eligible Patients
n=16525 Participants
Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection.
Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received.
Rocuronium
Succinylcholine
Cisatracurium
Mivacurium
Objective neuromuscular monitoring (acceleromyography)
Sugammadex
Neostigmine
|
|---|---|
|
Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing Neuromuscular Blocking Agent (NMBA) (Yes/no)
Monitoring applied
|
14463 Participants
|
|
Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing Neuromuscular Blocking Agent (NMBA) (Yes/no)
Monitoring not applied
|
2062 Participants
|
PRIMARY outcome
Timeframe: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hoursPopulation: Patients receiving succinylcholine only
Outcome measures
| Measure |
Eligible Patients
n=13905 Participants
Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection.
Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received.
Rocuronium
Succinylcholine
Cisatracurium
Mivacurium
Objective neuromuscular monitoring (acceleromyography)
Sugammadex
Neostigmine
|
|---|---|
|
Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing NMBA (Succinylcholine) (Yes/no)
Monitoring applied
|
4224 Participants
|
|
Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing NMBA (Succinylcholine) (Yes/no)
Monitoring not applied
|
9681 Participants
|
SECONDARY outcome
Timeframe: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hoursPopulation: Only participants with data on the outcome was analyzed, as per protocol.
The train-of-four (TOF) ratio is the ratio between the last and first measurements after four stimuli of the ulnar nerve at 2 Hz. The ratio should be at least 0.9 before tracheal extubation.
Outcome measures
| Measure |
Eligible Patients
n=16525 Participants
Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection.
Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received.
Rocuronium
Succinylcholine
Cisatracurium
Mivacurium
Objective neuromuscular monitoring (acceleromyography)
Sugammadex
Neostigmine
|
|---|---|
|
Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA
|
0.97 Train-of-four ratio
Interval 0.9 to 1.06
|
SECONDARY outcome
Timeframe: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hoursPopulation: Only participants with data on the outcome was analyzed, as per protocol.
Outcome measures
| Measure |
Eligible Patients
n=13090 Participants
Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection.
Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received.
Rocuronium
Succinylcholine
Cisatracurium
Mivacurium
Objective neuromuscular monitoring (acceleromyography)
Sugammadex
Neostigmine
|
|---|---|
|
Number of Participants With and Without Administration of Sugammadex in Cases Receiving a Non-depolarizing NMBA (Yes/no)
Yes
|
145 Participants
|
|
Number of Participants With and Without Administration of Sugammadex in Cases Receiving a Non-depolarizing NMBA (Yes/no)
No
|
12945 Participants
|
SECONDARY outcome
Timeframe: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hoursPopulation: Only participants with data on the outcome was analyzed, as per protocol.
Outcome measures
| Measure |
Eligible Patients
n=16525 Participants
Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection.
Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received.
Rocuronium
Succinylcholine
Cisatracurium
Mivacurium
Objective neuromuscular monitoring (acceleromyography)
Sugammadex
Neostigmine
|
|---|---|
|
Number of Participants With and Without Administration of Neostigmine in Cases Receiving a Non-depolarizing NMBA (Yes/no)
Yes
|
8570 Participants
|
|
Number of Participants With and Without Administration of Neostigmine in Cases Receiving a Non-depolarizing NMBA (Yes/no)
No
|
7955 Participants
|
SECONDARY outcome
Timeframe: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutesPopulation: Only participants with data on the outcome was analyzed, as per protocol.
Outcome measures
| Measure |
Eligible Patients
n=12700 Participants
Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection.
Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received.
Rocuronium
Succinylcholine
Cisatracurium
Mivacurium
Objective neuromuscular monitoring (acceleromyography)
Sugammadex
Neostigmine
|
|---|---|
|
Time in Minutes From Tracheal Extubation or Removal of Supraglottic Airway Device to Discharge From Post-anaesthesia Care Unit in Cases Involving a Non-depolarizing NMBA With and Without Neuromuscular Monitoring, Respectively
|
97 Minutes
Interval 63.0 to 157.0
|
SECONDARY outcome
Timeframe: in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hoursPopulation: Only participants with data on the outcome was analyzed, as per protocol.
Outcome measures
| Measure |
Eligible Patients
n=15983 Participants
Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection.
Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received.
Rocuronium
Succinylcholine
Cisatracurium
Mivacurium
Objective neuromuscular monitoring (acceleromyography)
Sugammadex
Neostigmine
|
|---|---|
|
Number of Participants With and Without Mild Oxygen Desaturation (<90%, But >80%) in Cases Receiving a Non-depolarizing NMBA
Desaturation
|
1753 Participants
|
|
Number of Participants With and Without Mild Oxygen Desaturation (<90%, But >80%) in Cases Receiving a Non-depolarizing NMBA
No desaturation
|
14230 Participants
|
SECONDARY outcome
Timeframe: in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hoursPopulation: Only participants with data on the outcome was analyzed, as per protocol.
Outcome measures
| Measure |
Eligible Patients
n=15983 Participants
Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection.
Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received.
Rocuronium
Succinylcholine
Cisatracurium
Mivacurium
Objective neuromuscular monitoring (acceleromyography)
Sugammadex
Neostigmine
|
|---|---|
|
Number of Participants With and Without Severe Oxygen Desaturation (<80%) in Cases Receiving a Non-depolarizing NMBA
Desaturation
|
295 Participants
|
|
Number of Participants With and Without Severe Oxygen Desaturation (<80%) in Cases Receiving a Non-depolarizing NMBA
No desaturation
|
15688 Participants
|
Adverse Events
Eligible Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. JLD Thomsen
Herlev Hospital, research unit, anesthesia
Phone: 004538633863
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place