Brief Title
Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery
Official Title
Effect of Deep Versus Moderate Neuromuscular Blockade on Peak Airway Pressures During Elective Laparoscopic Surgery
Brief Summary
This is a two period cross-over study randomizing patients undergoing laparoscopic surgery into 2 different groups: group 1 in which patients receive "deep neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "moderate blockade" and, group 2 in which patients receive "moderate neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "deep blockade". The deep neuromuscular block is defined as post tetanic count of 1 to 2 and the moderate neuromuscular block is defined as 1-2 twitches. In all patients, sugammadex is used to reverse the block at the end of surgery in order to obtain optimal extubating conditions.
Detailed Description
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
Peak Airway Pressures
Secondary Outcome
Abdominal Insufflation Pressure
Condition
Cholecystitis
Intervention
Deep to Moderate NMB
Study Arms / Comparison Groups
Deep to Moderate NMB
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
79
Start Date
December 27, 2016
Completion Date
February 6, 2019
Primary Completion Date
January 17, 2019
Eligibility Criteria
Inclusion Criteria: - Each participant must be willing and able to provide written informed consent for the study. - Each participant must be American Society of Anesthesiologists (ASA) class I, II or III. - Each participant must be scheduled for elective laparoscopic surgery (this includes robotic laparoscopic surgery). - Expected surgical duration of 60 min or longer Exclusion Criteria: - Inability to give informed oral or written consent - Known or suspected neuromuscular disorders impairing neuromuscular function; - True allergies as defined as hypotension, bronchospasm, or anaphylaxis to muscle relaxants, anesthetics or opioids - A history (patient or family) of malignant hyperthermia - A contraindication for neostigmine administration - Renal insufficiency, as defined by serum creatinine levels at 2.5 fold the normal level - Body mass index >40 kg/m^2 - Significant respiratory disease. - Planned postoperative mechanical ventilation
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ruchir Gupta, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02812186
Organization ID
823925
Responsible Party
Principal Investigator
Study Sponsor
Stony Brook University
Collaborators
Merck Sharp & Dohme Corp.
Study Sponsor
Ruchir Gupta, MD, Principal Investigator, Stony Brook Medicine
Verification Date
March 2020