A Study Comparing the Use of Deep or Standard Neuromuscular Blockade in Combination With Low or Standard Insufflation Pressures in Participants Undergoing Laparoscopic Cholecystectomy (P07982)
Condition: Gallbladder Disease
MeSH terms: Gallbladder Diseases
Intervention: Rocuronium; Insufflation; Sugammadex
Intervention description: NMB will be induced by intravenous (IV) administration of a bolus dose of 0.45 mg/kg rocuronium. NMB will be maintained using rocuronium infusion or additional bolus doses as needed for the management of NMB to the targeted depth according to the assigned treatment condition. - Standard NMB - administration of neuromuscular blocking agent (NMBA) titrated to a depth of blockade at a targeted TOF ratio of 10% (range: TOF count 2-3 to TOF ratio of 20%). - Deep NMB - administration of NMBA titrated to a targeted depth of 1-2 Post Tetanic Counts (PTCs) (range: 1-5 PTC).; Insufflation (injection) of carbon dioxide will be used to induce pneumoperitoneum, which is presence of air or gas in the abdominal (peritoneal) cavity.
Standard insufflation pressure - a starting pressure of 12 mmHg will be used.
Low insufflation pressure - a starting pressure of 8 mmHg will be used.; NMB will be reversed with IV administration of 2 or 4 mg/kg sugammadex (depending on the depth of NMB) according to the approved label for sugammadex.
Intervention MeSH terms: Bromides; Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this pilot study is to compare the use of deep or standard neuromuscular
      blockade (NMB) in combination with low or standard insufflation pressure in participants
      undergoing a surgical procedure, laparoscopic cholecystectomy. Insufflation refers to the
      injection of carbon dioxide into the abdomen during the laparoscopic surgery, to allow
      visualization of and access to the surgical field. The primary hypothesis of the study is
      that the use of sustained deep NMB improves the surgeon's overall satisfaction with surgical
      conditions as compared to standard NMB. The in-patient surgery is performed on Day 1 and the
      participant remains hospitalized for at least 48 hours following the surgery (or at least 24
      hours following the surgery, if local practice does not allow 48 hours of hospitalization
      post surgery). On Day 8, a follow-up visit/contact including all participants occurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) Class 1 or 2 or 3

          -  Scheduled to undergo an elective in-patient laparoscopic cholecystectomy procedure
             under general anesthesia with total intravenous anesthesia (TIVA) using propofol and
             remifentanil

          -  Eligible to undergo rocuronium-induced NMB for endotracheal intubation and maintenance
             of NMB

          -  Will recover in the post-anesthesia care unit (PACU) and remain in the hospital for at
             least 48 hours following the surgical procedure (or at least 24 hours following the
             surgical procedure, if local practice does not allow 48 hours of hospitalization post
             surgery)

          -  Body mass index (BMI) ≤35

          -  Willing and able to adhere to visit schedules including all required study assessments
             on Day 3 through 8 (daily pain and medication diary entry)

          -  For sexually active female participants of child-bearing potential - able to use a
             medically accepted method of contraception through 7 days after receiving
             protocol-specified medication

        Exclusion criteria:

          -  Neuromuscular disorders that may affect NMB and/or trial assessments

          -  Lifetime history of previous abdominal surgery, including laparotomies, Cesarean
             section, laparoscopic procedures or diagnostic laparoscopies

          -  Substance abuse or dependence (excluding nicotine) within the past 6 months

          -  History of a chronic pain condition (requiring continuous/daily pain medication prior
             to surgery)

          -  For female participants - lifetime history of a Cesarean section, or has given birth
             to one or more children within the last year, or is currently pregnant or has the
             intention to become pregnant between randomization and pregnancy follow-up contact ≥30
             days after administration of trial treatments (rocuronium, sugammadex)

          -  Evidence of acute cholecystitis

          -  Dialysis-dependency or suspected of having severe renal insufficiency

          -  Significant hepatic dysfunction that would prevent participation in the trial

          -  History of or family history of malignant hyperthermia

          -  Allergy to trial treatments (rocuronium or sugammadex) or their excipients, to
             opioids/opiates, or other medication used during general anesthesia

          -  Received or is planned to receive toremifene or fusidic acid within 24 hours before or
             after receiving rocuronium or sugammadex

          -  Expected transfer to an Intensive Care Unit after surgery

          -  Any clinically significant condition or situation, other than the reason for the
             cholecystectomy that would interfere with the trial evaluations or optimal
             participation in the trial

          -  Used any investigational drugs within 30 days of randomization

          -  Participated in any other clinical trial within 30 days of signing the informed
             consent form of the current trial

          -  Participated in any other clinical trial involving any personnel of the
             investigational or Sponsor staff directly involved with this trial

          -  Is a family member of any personnel of the investigational or Sponsor staff directly
             involved with this trial