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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
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 neuromuscular blockade Procedure: moderate neuromuscular blockade 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)
Estimated Enrollment : 100 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 11, 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rocuronium

Arm Intervention/treatment
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.

Drug: Rocuronium
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.

Drug: Rocuronium



Primary Outcome Measures :
  1. Peak Airway Pressures [ Time Frame: intra-operative ]

Secondary Outcome Measures :
  1. Heart rate [ Time Frame: intra-operative: measured every 15 min at the time of airway pressure measurement ]
    beats per minute

  2. Blood Pressure [ Time Frame: intra-operative: measured every 15 min at the time of airway pressure measurement ]
    systolic/diastolic



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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

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Responsible Party: Ruchir Gupta, Clinical Assistant Professor, Stony Brook University
ClinicalTrials.gov Identifier: NCT02812186     History of Changes
Other Study ID Numbers: 823925
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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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Kidney Diseases
Renal Insufficiency, Chronic
Prolapse
Endometriosis
Cholecystitis
Acalculous Cholecystitis
Intestinal Obstruction
Uterine Prolapse
Urologic Diseases
Renal Insufficiency
Pathological Conditions, Anatomical
Genital Diseases, Female
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