Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Digestive System Diseases

Rare Diseases

Prostatic Neoplasms

Kidney Diseases

Leiomyoma

Prolapse

Myofibroma

Endometriosis

Uterine Prolapse

Cholecystitis

Acalculous Cholecystitis

Intestinal Obstruction

Renal Insufficiency, Chronic

Renal Insufficiency

Genital Diseases

Urogenital Diseases

Male Urogenital Diseases

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Chronic Disease

Disease Attributes

Genital Diseases, Female

Pathological Conditions, Anatomical

Gallbladder Diseases

Biliary Tract Diseases

Gastrointestinal Diseases

Intestinal Diseases

Uterine Diseases

Pelvic Organ Prolapse

Chronic Graft Versus Host Disease

All Drugs and Chemicals

Central Nervous System Depressants

Other Dietary Supplements

Rocuronium

Benzocaine

Neuromuscular Nondepolarizing Agents

Neuromuscular Blocking Agents

Tannic Acid

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.

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.

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.

Deep to Moderate NMB

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.

Moderate to Deep NMB

Ruchir Gupta, MD

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.

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.

Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery

Effect of Deep Versus Moderate Neuromuscular Blockade on Peak Airway Pressures During Elective Laparoscopic Surgery

Fully analyzed results may be shared with Merck Investigator Studies Program personnel after the study has completed

To determine if a deep NMB can lead to lower peak airway pressures in patients undergoing laparoscopic procedures when compared to a moderate NMB

To compare surgical operating condition by Abdominal Insufflation Pressure in patients undergoing laparoscopic procedures using deep NMB versus moderate NMB

To compare surgical operating condition by Surgical Rating Scale (SRS) in patients undergoing laparoscopic procedures using deep NMB versus moderate NMB

Surgical Rating Score scores are on a 1-5 scale with 1 = extremely poor conditions, 2 = poor conditions, 3 = adequate conditions, 4 = good conditions, 5= excellent conditions. Higher scores mean a better outcome.

Merck Sharp & Dohme LLC

Stony Brook University

Clinical Assistant Professor

This group will underwent neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion or during the second portion of the surgery

Deep NMB

This group underwent moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery or during the second portion of the surgery

Moderate NMB

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Procedure

Dr. Ruchir Gupta

Mean

Maximum

This group underwent deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery or during the second portion of the surgery

This group underwent moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery or during the second period of the surgery

Peak Airway Pressures

This group underwent deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion or during the second portion of the surgery

Abdominal Insufflation Pressure

ModerateNMB

Surgical Rating Scale

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.

Rocuronium

Deep to Moderate Neuromuscular Block (NMB)

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.

Rocuronium

Period 1

Period 2

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery	NCT02812186	Cholecystitis Endometriosis Bowel Obstructi... Fibroids Prostate Cancer Chronic Kidney ... Uterine Prolaps...	Deep to Moderat... Moderate to Dee... Rocuronium	18 Years -	Stony Brook University
Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery	NCT02812186	Cholecystitis Endometriosis Bowel Obstructi... Fibroids Prostate Cancer Chronic Kidney ... Uterine Prolaps...	Deep to Moderat... Moderate to Dee... Rocuronium	18 Years -	Stony Brook University

Spots Global Cancer Trial Database for moderate to deep nmb