Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery

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 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

NCT ID

NCT02812186

Organization ID

823925

Responsible Party

Principal Investigator

Study Sponsor

Stony Brook University

Collaborators

 Merck Sharp & Dohme LLC

Study Sponsor

Ruchir Gupta, MD, Principal Investigator, Stony Brook Medicine

Verification Date

March 2020