Clinical trial NCT02812186: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cholecystitis
Endometriosis
Bowel Obstruction
Fibroids
Prostate Cancer
Chronic Kidney Disease
Uterine Prolapse
Keywords: Neuromuscular blockade
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2016-06-24
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Peak Airway Pressures
timeFrame: Intra-operative, from intubation time to extubation time
Secondary outcomes:
measure: Abdominal Insufflation Pressure
timeFrame: Intra-operative, from intubation time to extubation time
measure: Surgical Rating Scale
timeFrame: Intra-operative, from intubation time to extubation time
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
affiliation: Stony Brook Medicine
name: Ruchir Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References: