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Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT02812186
Recruitment Status : Completed
First Posted : June 24, 2016
Results First Posted : April 8, 2020
Last Update Posted : April 8, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ruchir Gupta, Stony Brook University

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.

Condition or disease Intervention/treatment Phase
Cholecystitis Endometriosis Bowel Obstruction Fibroids Prostate Cancer Chronic Kidney Disease Uterine Prolapse Procedure: Deep to Moderate NMB Procedure: Moderate to Deep NMB Drug: Rocuronium Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 17, 2019
Actual Study Completion Date : February 6, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rocuronium

Arm Intervention/treatment
Deep to Moderate NMB
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 to Moderate NMB
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.

Drug: Rocuronium
Moderate to Deep 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.
Procedure: Moderate to Deep 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.

Drug: Rocuronium



Primary Outcome Measures :
  1. Peak Airway Pressures [ Time Frame: Intra-operative, from intubation time to extubation time ]
    To determine if a deep NMB can lead to lower peak airway pressures in patients undergoing laparoscopic procedures when compared to a moderate NMB


Secondary Outcome Measures :
  1. Abdominal Insufflation Pressure [ Time Frame: Intra-operative, from intubation time to extubation time ]
    To compare surgical operating condition by Abdominal Insufflation Pressure in patients undergoing laparoscopic procedures using deep NMB versus moderate NMB

  2. Surgical Rating Scale [ Time Frame: Intra-operative, from intubation time to extubation time ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, New York
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Ruchir Gupta, MD Stony Brook Medicine
  Study Documents (Full-Text)

Documents provided by Ruchir Gupta, Stony Brook University:
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Responsible Party: Ruchir Gupta, Clinical Assistant Professor, Stony Brook University
ClinicalTrials.gov Identifier: NCT02812186    
Other Study ID Numbers: 823925
First Posted: June 24, 2016    Key Record Dates
Results First Posted: April 8, 2020
Last Update Posted: April 8, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Fully analyzed results may be shared with Merck Investigator Studies Program personnel after the study has completed
Keywords provided by Ruchir Gupta, Stony Brook University:
Neuromuscular blockade
Additional relevant MeSH terms:
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Cholecystitis
Intestinal Obstruction
Kidney Diseases
Renal Insufficiency, Chronic
Endometriosis
Uterine Prolapse
Prolapse
Urologic Diseases
Renal Insufficiency
Pathological Conditions, Anatomical
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Uterine Diseases
Pelvic Organ Prolapse
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs