Neuromuscular Blockade, Postoperative Complications
Conditions
Keywords
Postoperative Pulmonary Complications, Residual Neuromuscular Blockade, Cardiac Surgical Procedures
Brief summary
The investigators will conduct a prospective, randomized trial to assess the impact of neuromuscular blockade on early (\<72 hours post-ICU admission) postoperative respiratory complications in cardiac surgical patients. The study will compare continual neuromuscular blockade with cisatracurium to a single dose of succinylcholine during general anesthesia for cardiac surgery.
Detailed description
Residual neuromuscular blockade during the immediate postoperative period is an important patient safety issue. Although used to facilitate the technical performance of surgery, clinical studies have associated neuromuscular blockade (NMB) with increased incidence of postoperative respiratory complications. This effect is likely mediated by residual neuromuscular blockade interfering with airway tone and respiratory effort, leading to postoperative pneumonia, atelectasis or aspiration. However, the vast majority of these studies have involved non-cardiac patient populations, yet patients undergoing cardiac surgery are even more susceptible to the detrimental effects of residual neuromuscular blockade for a number of reasons. Despite widespread utilization of paralysis during cardiac surgery, very little is known about residual neuromuscular blockade in patients following cardiac surgery. Previously published clinical studies date from over a decade ago or are based on retrospective databases from non-cardiac surgery patients, precluding generalizable conclusions. Given the substantial role of neuromuscular blockade in the traditional management of cardiac surgical patients, prospective data is needed to determine the veracity of this association as well as the surgical tolerability of protocols that minimize intraoperative paralysis. The investigators will conduct a prospective, randomized trial to assess impact of neuromuscular blockade on early (\<72 hours post-ICU admission) postoperative respiratory complications.
Interventions
DRUGSuccinylcholine
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.
DRUGCisatracurium
Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Open label drug administration. Outcomes assessor and care providers are otherwise masked.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Elective cardiac surgery (CABG, valve replacement, CABG + valve) requiring cardiopulmonary bypass
Exclusion criteria
* Emergency surgery * Extremes of age * Previous cardiac surgery * Clinical contraindications to succinylcholine or cisatracurium * Anticipated difficult tracheal intubation * Preoperative mechanical ventilation * Preoperative pharmacologic/mechanical hemodynamic support
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postoperative Pulmonary Complications | 72 hours following surgical procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Conditions | During general anesthesia | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Group CIS | Group SUX | Total |
|---|---|---|---|
| Age, Continuous | 66.0 years STANDARD_DEVIATION 14.5 | 64.1 years STANDARD_DEVIATION 14.6 | 65.1 years STANDARD_DEVIATION 14.5 |
| Body Mass Index | 30.2 kg/m2 STANDARD_DEVIATION 6.9 | 28.2 kg/m2 STANDARD_DEVIATION 5.9 | 29.2 kg/m2 STANDARD_DEVIATION 6.4 |
| Euroscore | 5.56 units on a scale STANDARD_DEVIATION 3.08 | 5.28 units on a scale STANDARD_DEVIATION 3.08 | 5.42 units on a scale STANDARD_DEVIATION 3.07 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 14 Participants | 21 Participants | 35 Participants |
| Sex: Female, Male Male | 36 Participants | 29 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Number of Participants With Postoperative Pulmonary Complications
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.
Time frame: 72 hours following surgical procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group CIS | Number of Participants With Postoperative Pulmonary Complications | 8 Participants |
| Group SUX | Number of Participants With Postoperative Pulmonary Complications | 8 Participants |
p-value: 1Chi-squared
Secondary
Surgical Conditions
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
Time frame: During general anesthesia
Population: 2 participants in the CIS group and 4 participants in the SUX group had missing data for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group CIS | Surgical Conditions | 4.96 units on a scale | Standard Deviation 0.2 |
| Group SUX | Surgical Conditions | 4.65 units on a scale | Standard Deviation 0.85 |
p-value: 0.02t-test, 2 sided