Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery
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|ClinicalTrials.gov Identifier: NCT02812186|
Recruitment Status : Enrolling by invitation
First Posted : June 24, 2016
Last Update Posted : March 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cholecystitis Endometriosis Bowel Obstruction Fibroids Prostate Cancer Chronic Kidney Disease Uterine Prolapse||Procedure: deep neuromuscular blockade Procedure: moderate neuromuscular blockade Drug: Rocuronium||Phase 4|
Neuromuscular blockade (NMB) is frequently utilized in laparoscopic procedures to improve surgical conditions by relaxing the abdominal muscles and thus facilitating insufflation with carbon dioxide to optimize surgical view. Increased airway pressures can lead to an increase in alveolar and perivascular edema, a decline in dynamic lung compliance and hypoxemia.
Several studies have investigated surgical view under deep vs. moderate neuromuscular blockade. Literature supports deep neuromuscular blockade providing better operating conditions/view by a surgeon and low airway pressures but, potentially, longer duration to extubation and worse respiratory mechanics at the end of anesthesia versus moderate neuromuscular blockade which shows worse operating conditions/view by a surgeon and worse airway pressures but possibly shorter duration to extubation and better respiratory mechanics at the end of anesthesia.
Thus, there is clearly equipoise with regard to the comparative effectiveness of deep vs medium NMB. Therefore, this study is designed to ascertain if a deep neuromuscular block will decrease the airway pressures in patients undergoing laparoscopic procedures compared to those under a moderate block. A reduction in airway pressures may lead to a decrease in the complications associated with elevated airway pressures including hypoxemia, total static lung compliance, alveolar edema, and long term morbidity. Additionally, the study aims to determine if time from administration of sugammadex to reversal is different between patients that have a moderate NMB as compared to a deep NMB.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Effect of Deep Versus Moderate Neuromuscular Blockade on Peak Airway Pressures During Elective Laparoscopic Surgery|
|Actual Study Start Date :||December 27, 2016|
|Actual Primary Completion Date :||January 11, 2019|
|Estimated Study Completion Date :||May 2019|
deep neuromuscular blockade
This group will undergo deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery followed by a period of moderate blockade.
Procedure: deep neuromuscular blockade
After induction and intubation, the patient will be maintained in a "deep" (post-tetanic count, one or two twitches) neuromuscular block (NMB), obtained with an intubating dose of rocuronium of 0.6 mg/kg followed by a continuous infusion. The initial infusion rate will be set at 0.6 mg/kg/h. To minimize any type of carry-over effects, after the completion of the deep NMB 20 minute period, a "transition period" of approximately 10-15 minutes will begin. During this "transition period" the rocuronium infusion will be paused and the Train of Four (TOF) monitor will be set to every 1-2 min. Once the patient has achieved a "moderate" NMB state (one to two twitches), the infusion of the muscle relaxant will be resumed at a low dose to maintain the patient at this level of blockade.
moderate neuromuscular blockade
This group will undergo moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery followed by a period of deep blockade.
Procedure: moderate neuromuscular blockade
After induction and intubation, the patient will be maintained in a "deep" (post-tetanic count, one or two twitches) neuromuscular block (NMB), obtained with an intubating dose of rocuronium of 0.6 mg/kg followed by a continuous infusion. The initial infusion rate will be set at 0.6 mg/kg/h. To minimize any type of carry-over effects, after completion of the moderate NMB 20 minute period, a "transition period" of approximately 10-15 min will begin. During this "transition period" the rocuronium infusion will be increased in increments of 0.1-0.2 mg/kg/hr. and the TOF monitor will be set to every 1-2 min. Once the patient has no twitches and a PTC of 0-1 ("deep" NMB) the infusion will be adjusted to maintain the patient at this level of NMB.
- Peak Airway Pressures [ Time Frame: intra-operative ]
- Heart rate [ Time Frame: intra-operative: measured every 15 min at the time of airway pressure measurement ]beats per minute
- Blood Pressure [ Time Frame: intra-operative: measured every 15 min at the time of airway pressure measurement ]systolic/diastolic
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): NCT02812186
|United States, New York|
|Stony Brook University Hospital|
|Stony Brook, New York, United States, 11794|
|Principal Investigator:||Ruchir Gupta, MD||Stony Brook Medicine|