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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group CIS | Active Comparator | 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). |
|
| Group SUX | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Succinylcholine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours following surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During general anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca M Gerlach, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 72 hours following surgical procedure |
|
10 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca M Gerlach, MD | University of Chicago | 773-702-6700 | rgerlach@dacc.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 5, 2017 | Jan 22, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D055191 | Delayed Emergence from Anesthesia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013390 | Succinylcholine |
| C101584 | cisatracurium |
| ID | Term |
|---|---|
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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Open label drug administration. Outcomes assessor and care providers are otherwise masked.
|
| Cisatracurium | Drug | Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia. |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Euroscore | The additive Euroscore (European System for Cardiac Operative Risk Evaluation) is a measure of predicted operative mortality for patients undergoing cardiac surgery. The score is comprised of patient-related factors, cardiac-related factors, and operation-related factors. Higher scores indicate greater risk for operative mortality (possible range 0-43). | Mean | Standard Deviation | units on a scale |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| OG001 |
| 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. |
|
|
|
| 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 | 2 participants in the CIS group and 4 participants in the SUX group had missing data for this outcome. | Posted | Mean | Standard Deviation | units on a scale | During general anesthesia |
|
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 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. | 0 | 50 | 0 | 50 | 0 | 50 |
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| D009930 |
| Organic Chemicals |
| D013386 | Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009861 | Onium Compounds |