Trial Outcomes & Findings for Effect of Neuromuscular Blockade on Pulmonary Complications in Elective Cardiac Surgery (NCT NCT02635542)
NCT ID: NCT02635542
Last Updated: 2018-07-17
Results Overview
Having at least one of the following complications, determined according to pre-specified criteria: extubation delayed \>24hrs, reintubation, mechanical respiratory support, pneumonia, aspiration, ARDS (Acute Respiratory Distress Syndrome), or mortality from respiratory arrest.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
72 hours following surgical procedure
Results posted on
2018-07-17
Participant Flow
Participant milestones
| Measure |
Group CIS
Continual neuromuscular blockade (standard therapy) during general anesthesia will be provided with cisatracurium (CIS), with 0.2mg/kg IV given as an initial dose and repeated dosing determined by neuromuscular blockade monitoring (peripheral nerve stimulator maintained at 1-2 twitches).
Cisatracurium: Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia.
|
Group SUX
A single dose of neuromuscular blockade (experimental group) will be provided at the start of anesthesia with succinylcholine (SUX), with 1mg/kg IV given as an initial dose and no repeat dosing.
Succinylcholine: Succinylcholine will be used to facilitate endotracheal intubation for general anesthesia in the operating room. No additional neuromuscular blockade will be provided during general anesthesia.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
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 |
Group CIS
n=50 Participants
Continual neuromuscular blockade (standard therapy) during general anesthesia will be provided with cisatracurium (CIS), with 0.2mg/kg IV given as an initial dose and repeated dosing determined by neuromuscular blockade monitoring (peripheral nerve stimulator maintained at 1-2 twitches).
Cisatracurium: Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia.
|
Group SUX
n=50 Participants
A single dose of neuromuscular blockade (experimental group) will be provided at the start of anesthesia with succinylcholine (SUX), with 1mg/kg IV given as an initial dose and no repeat dosing.
Succinylcholine: Succinylcholine will be used to facilitate endotracheal intubation for general anesthesia in the operating room. No additional neuromuscular blockade will be provided during general anesthesia.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 14.5 • n=50 Participants
|
64.1 years
STANDARD_DEVIATION 14.6 • n=50 Participants
|
65.1 years
STANDARD_DEVIATION 14.5 • n=100 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=50 Participants
|
21 Participants
n=50 Participants
|
35 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=50 Participants
|
29 Participants
n=50 Participants
|
65 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
50 participants
n=50 Participants
|
50 participants
n=50 Participants
|
100 participants
n=100 Participants
|
|
Euroscore
|
5.56 units on a scale
STANDARD_DEVIATION 3.08 • n=50 Participants
|
5.28 units on a scale
STANDARD_DEVIATION 3.08 • n=50 Participants
|
5.42 units on a scale
STANDARD_DEVIATION 3.07 • n=100 Participants
|
|
Body Mass Index
|
30.2 kg/m2
STANDARD_DEVIATION 6.9 • n=50 Participants
|
28.2 kg/m2
STANDARD_DEVIATION 5.9 • n=50 Participants
|
29.2 kg/m2
STANDARD_DEVIATION 6.4 • n=100 Participants
|
PRIMARY outcome
Timeframe: 72 hours following surgical procedureHaving at least one of the following complications, determined according to pre-specified criteria: extubation delayed \>24hrs, reintubation, mechanical respiratory support, pneumonia, aspiration, ARDS (Acute Respiratory Distress Syndrome), or mortality from respiratory arrest.
Outcome measures
| Measure |
Group CIS
n=50 Participants
Continual neuromuscular blockade (standard therapy) during general anesthesia will be provided with cisatracurium (CIS), with 0.2mg/kg IV given as an initial dose and repeated dosing determined by neuromuscular blockade monitoring (peripheral nerve stimulator maintained at 1-2 twitches).
Cisatracurium: Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia.
|
Group SUX
n=50 Participants
A single dose of neuromuscular blockade (experimental group) will be provided at the start of anesthesia with succinylcholine (SUX), with 1mg/kg IV given as an initial dose and no repeat dosing.
Succinylcholine: Succinylcholine will be used to facilitate endotracheal intubation for general anesthesia in the operating room. No additional neuromuscular blockade will be provided during general anesthesia.
|
|---|---|---|
|
Number of Participants With Postoperative Pulmonary Complications
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: During general anesthesiaPopulation: 2 participants in the CIS group and 4 participants in the SUX group had missing data for this outcome.
Assessed by surgeon questionnaire designed for study to determine any negative effects impeding the progress of surgery or safety, on scale of 1=poor to 5=excellent
Outcome measures
| Measure |
Group CIS
n=48 Participants
Continual neuromuscular blockade (standard therapy) during general anesthesia will be provided with cisatracurium (CIS), with 0.2mg/kg IV given as an initial dose and repeated dosing determined by neuromuscular blockade monitoring (peripheral nerve stimulator maintained at 1-2 twitches).
Cisatracurium: Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia.
|
Group SUX
n=46 Participants
A single dose of neuromuscular blockade (experimental group) will be provided at the start of anesthesia with succinylcholine (SUX), with 1mg/kg IV given as an initial dose and no repeat dosing.
Succinylcholine: Succinylcholine will be used to facilitate endotracheal intubation for general anesthesia in the operating room. No additional neuromuscular blockade will be provided during general anesthesia.
|
|---|---|---|
|
Surgical Conditions
|
4.96 units on a scale
Standard Deviation 0.20
|
4.65 units on a scale
Standard Deviation 0.85
|
Adverse Events
Group CIS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group SUX
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place