Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery
Condition: Cholecystitis; Endometriosis; Bowel Obstruction; Fibroids; Prostate Cancer; Chronic Kidney Disease; Uterine Prolapse
MeSH terms: Cholecystitis; Intestinal Obstruction; Kidney Diseases; Renal Insufficiency, Chronic; Endometriosis; Uterine Prolapse; Prolapse
Intervention: Deep to Moderate NMB; Moderate to Deep NMB; Rocuronium
Intervention description: 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.; 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.
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neuromuscular blockade

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.
    

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