Effect of Neuromuscular Blockade on Pulmonary Complications in Elective Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT02635542|
Recruitment Status : Completed
First Posted : December 21, 2015
Results First Posted : July 17, 2018
Last Update Posted : July 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neuromuscular Blockade Postoperative Complications||Drug: Succinylcholine Drug: Cisatracurium||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||Open label drug administration. Outcomes assessor and care providers are otherwise masked.|
|Official Title:||Prospective, Randomized Trial Comparing Effect of General Anesthesia With and Without Neuromuscular Blockade on Postoperative Pulmonary Complications in Elective Cardiac Surgical Patients|
|Actual Study Start Date :||March 2016|
|Actual Primary Completion Date :||September 15, 2017|
|Actual Study Completion Date :||September 15, 2017|
Active Comparator: 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 will be used to maintain neuromuscular blockade during general anesthesia.
Other Name: Nimbex
Experimental: 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 will be used to facilitate endotracheal intubation for general anesthesia in the operating room. No additional neuromuscular blockade will be provided during general anesthesia.
Other Name: Suxamethonium
- Number of Participants With Postoperative Pulmonary Complications [ Time Frame: 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.
- Surgical Conditions [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635542
|United States, Illinois|
|University of Chicago Medicine|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Rebecca M Gerlach, MD||University of Chicago|